Electroconvulsive Therapy – Guidelines for Health Authorities in British Columbia

2000 document from UBC Department of Psychiatry and the BC Ministry of Health

Download PDF File (3.7 mb)

Harold Sackeim Mecta deposition video clips

Here are a number of clips from the videotaped deposition of Harold Sackeim (2004). Sackeim was the expert witness for Mecta in a lawsuit in California.

You can read most of the deposition here, in PDF format.

I’m splitting the videos into two pages to reduce your load. If the page loads slowly, or the videos don’t load, try again in thirty minutes…it’s likely YouTube is down.

Richard Abrams is defensive, says Harold Sackeim

Harold Sackeim, king of ECT, discusses his complaints about Richard Abrams, president of Somatics, Inc., saying that Abrams is defensive because of the “fascist” groups, and goes too far with his defensiveness by ignoring the “problems” inherent with ECT. Meow!

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Harold Sackeim tells NY Assemblyman Rivera he “discarded” requests

After making a public offer to evaluate individuals with damage after ECT, Sackeim explains that he told the NY Assemblyman Peter Rivera (D-Bronx) he discarded the responses. They “spent the day” together. How cozy. Rivera is head of the New York Committee on Mental Health. Harold has more than one cozy relationship, and it’s paid off in a big way for him.

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Killroy was here

An endorsement? No, but Harold admits he’s been here. Everyone, please, a warm welcome to the Lord of the Dance, Harold Sackeim.

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He’s said it, very clearly

Very emphatically: “I don’t dispute that there are some people who have very severe memory loss. I’ve been the one who’s been saying that very clearly.”

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2 million people?

“Uh, what I do know is that probably about 2 million people are receive ECT each year…” When questioned by the attorney asking if he “knows” that, Harold backpedals and says he said “estimate.” A few years ago he told Extra it was a million. I guess that Cyberonics VNS device isn’t working out so well.

Perhaps saying “I do know” and then claiming he said “estimate” is being a tad picky. But consider that this seems to be a habit with him: reinventing himself, parading himself as the champion of the shock patient by criticizing “Dick” Abrams, and claiming he’s a purist scientist, even when he admits statistics were not genuine statistics as claimed, but merely a guesstimate. Since the long-held guess of how many Americans receive ECT annually is 100,000 to 200,000 (usually quoted as 100,000 in the media), where on earth did he get this 2 million figure for the world?

Oh, it’s an estimate. He made it up.

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Follow the money…

Here’s something he can’t make up, because there’s a paper trail. He billed Mecta for $10,875 for pretrial consulting. And that was *before* the trial, or even this deposition, took place. No telling what the final bill will be! His rate is $500 an hour to help Mecta defend against a lawsuit. Notice how he refuses to say the amount, instead, referring to the “rate that’s there.” For whatever reason, Harold Sackeim cannot say the words “I charge $500 an hour.”

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Part 2 of the video deposition

Harold Sackeim Mecta deposition video clips, page 2

The Awakening

This clip is an interesting explanation of why psychiatrists have apparently been unaware for 70 years that ECT can and does cause profound memory loss and cognitive damage. The reason? Because until a few years ago, the only persons who complained of severe memory loss also said it didn’t help them. It took finding some patients who experienced devastating memory loss who would also proclaim it “saved their life” before Harold Sackeim would listen.

Hey, I’m not the one who said it…Harold is. He’s the champion of the shock patient, at least in his own head. Maybe he needs to revisit the early years of Sackeimology, when his research revolved around self deception, the lies we tell ourselves.

Harold (call him doctor, damn you!) relates an interesting story, if true. He’s been known to make up statistics and a vignette or two. And he questioned whether or not the individuals on ect.org were really ECT patients. That’s called projection, Harold. Or deflection. You should have learned these terms when you studied Sackeimology.

The story takes place at an ECT donut course. (Shock docs and donuts are like cops and donuts.) One of the “very famous people” (that could really only be Abrams, Fink or Kellner, probably the Finkster) announced that profound memory loss just doesn’t happen. But our hero Harold asked the audience – all shock docs – if they’d encountered it. Two-thirds raised their hands. Oops. 70 years of denial down the drain.

It was almost a watershed moment, he says. The only thing missing was the heavens opening and the Angel Gabriel trumpeting the good news: Harold Sackeim is GOD, everyone. He’s your savior.

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FDA and ECT devices

This is the well-known story of how the FDA has been lobbied by the industry to change ECT devices from Class III to Class II. What’s interesting (and keeps popping up in Harold’s testimony) is that apparently the psych rights movement is having an impact on things. Despite his admitting that he speaks with the FDA regularly, and that the industry has lobbied the FDA for the change, Harold says the FDA is afraid to make a move.

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“I DO consider it.”

When asked if he discounts the many personal accounts of memory loss post-ECT, he responds that he does consider it.

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Electrical parameters

Harold discusses the parameters of ECT, cognitive side effects and Mecta machines.

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What they knew, when they knew

Is it necessary to inform patients of the risk of permanent, severe memory loss? Harold says it’s not in dispute…of course you tell them, and he always does. At least in the last three or four years…once they discovered it really happens. Before then, well, they kinda knew, but they just had no scientific evidence that it did, and the wrong kinds of people had been talking about it. So it’s not their fault because they didn’t know. They just didn’t know. Until a few years ago.

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Sackeim: “I got the field to do that”

Harold says the APA Task Force Report now says that ECT can cause profound memory loss. ECT patients have only been saying that for…hmmm, nearly SEVENTY YEARS!

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Memory and cognitive effects of ECT

Memory and cognitive effects of ECT: informing and assessing patients

Advances in Psychiatric Treatment (2006), vol. 12, 228 238

Harold Robertson & Robin Pryor

Abstract:

Over the past few years electroconvulsive therapy (ECT) has come under increased scrutiny in the UK, with the first systematic review of patients’ experiences and new national guidelines. Our aim in this article is to translate recent and sometimes confusing research and policy statements into practical guidance that benefits patients. We examined the evidence on the permanent memory and cognitive effects of ECT, with a focus on delineating their nature, understanding how ECT may cause them, informing prospective patients about them, and assessing their impact on former patients. We describe a simple and effective method for assessing retrograde amnesia. Data do not exist at this time to confirm the mechanisms by which ECT exerts its adverse effects, but clinicians should fully inform patients of the possible permanent adverse effects of the treatment, which include amnesia, memory disability and cognitive disability, and should provide follow-up testing using relevant instruments.

In January 2002, as part of a review of electroconvulsive therapy (ECT) undertaken by the UK’s Department of Health, the Service User Research Enterprise (SURE) published the first-ever systematic review of patients’ views on ECT (Service User Research Institute, 2002). The review encompassed several large-scale surveys by or of people who had received ECT in the UK (United Kingdom Advocacy Network, 1996; ECT Anonymous, 1999; Pedler, 2000). In April 2003, the National Institute for Clinical Excellence (now the National Institute for Health and Clinical Excellence, NICE) issued guidance on the use of ECT, and at the same time, the UK ECT Review Group published a review of its safety and efficacy (National Institute for Health and Clinical Excellence, 2003; UK ECT Review Group, 2003). The Royal College of Psychiatrists has established the ECT Accreditation Service and revised its guidelines for practitioners to take into account the NICE advice (Royal College of Psychiatrists, 2005).

Some of the conclusions to come out of the new work – in particular, that at least one-third of patients experience permanent amnesia (Service User Research Institute, 2002; Rose et al, 2003; Scott, 2005), that half of patients had not received an adequate explanation prior to treatment (Rose et al, 2003, 2005; Philpot et al, 2004) and that newer methods of ECT have not resulted in an appreciable decrease in adverse effects (UK ECT Review Group, 2003) – suggest that changes are overdue in both practice and policy.

The new evidence presents opportunities for improving clinical care in several areas: delineating the nature of ECT’s permanent adverse effects; developing adequate and relevant tools to assess patients; and providing consent that is fully informed.

Defining deficits

It is evident from a close reading of patient reports such as those documented by SURE that ‘memory’ is too simple a term to encompass the range of ECT’s permanent adverse effects, yet there has been almost no work done on improving terminology (Box 1). The confusion goes back to the first instrument specifically designed to assess people given ECT, the Squire Memory Questionnaire (SMQ; Squire et al, 1979). The SMQ was developed to distinguish between the cognitive impairments associated with depression and those caused by ECT. Although Squire and his colleagues believed that they had done this (Squire & Slater, 1983; Squire & Zouzounis, 1988), others have not used the test for its intended purpose, and it is hard to say whether the SMQ has muddied the water more than it has cleared it. Although often spoken of as if it measured a unitary entity ‘memory’, the SMQ actually encompasses multiple dimensions of cognition: attention, alertness, concentration, learning. It does not at all address the most common effect of ECT, which is variously called amnesia, retrograde amnesia or memory loss. By these terms is generally understood the obliteration of a specific time period in a person’s life.

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It is when ‘memory’ is used as a shorthand term for both retrograde amnesia and ongoing difficulties with memory function in the present that confusion ensues, a confusion that intensifies when the latter is sometimes called ‘anterograde amnesia’. Although most will understand anterograde amnesia to mean ongoing memory disability, this is not always the case. The US National Institute of Mental Health has defined anterograde amnesia as the inability to remember events that happened after ECT (National Institutes of Health, 1985) and the College’s new handbook (Royal College of Psychiatrists, 2005) appears to use it in the same way.

To confuse matters further, the term ‘short-term memory loss’ is sometimes used as a synonym for anterograde amnesia. Short term to some will mean temporary, to others it will be seen as a description of the type of memory that is affected – the ability to retain information for a short period, or working memory (Baddeley & Hitch, 1974) – which says nothing about its longevity. The term ‘temporary’ rather than ‘short-term’ should always be used to refer to effects that resolve, but even then it should be used with caution because neuropsychology recognises that transient impairment of cognitive function may have residual permanent effects. ‘Dysfunction’ or ‘disability’ should be used rather than ‘loss’ (which implies a one-time event) to refer to ongoing difficulties with memory ability and cognition.

If the term anterograde amnesia must be used, it should be clearly defined as difficulties with memory in daily life, and examples given (Box 2).

Inevitably, memory overlaps with and subsumes other cognitive functions, such as learning and attention as well as overall intelligence. When individuals who have had ECT report ongoing memory disability, it is necessary for a clinician
trained in neuropsychological evaluation to tease out the roles played by attention, concentration, overall slowed mental processing and deficits of executive function such as inability to shift mental set. The ECT psychiatrist and treatment team may not be trained in neuropsychological evaluation, since outside of research settings it is not routinely performed on people who have had ECT. When it is, it is usually initiated by the patient, not the doctor. Because of this, the treating psychiatrist may fear personal liability and thus be unwilling to attribute deficits to ECT.

It has long been known that ECT can produce deficits in non-memory-related cognitive function (Calev, 1994). However, long-term studies comparing controls and people who have had ECT to determine when and if non-memory cognitive function normalises after ECT have not been done. A comprehensive battery of neuropsychological tests carried out on individuals who had had ECT between 9 months and 30 years previously revealed impairment on a range of measures, even after controlling for the effects of illness and medication (Freeman et al, 1980).

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Despite recommendations that psychiatrists inform patients of non-memory cognitive after- effects (Calev, 1994) and warn them that ‘they are not going to function well on more tasks than they anticipate’ (Calev et al, 1995), patients are still routinely not informed about these effects; there is no mention of them in the recommended consent forms of the American Psychiatric Association (APA; 2001), the Royal College of Psychiatrists (2005: Appendix 1V) or the manufacturers of ECT equipment. This may contribute to the consistent findings (Rose et al, 2003, 2005; Philpot et al, 2004) that half of people given ECT say they did not receive an adequate explanation of the treatment.

The current APA consent forms not only contain no warnings about adverse effects on cognition, but advise that ‘Most patients report that memory is actually improved by ECT’ (American Psychiatric Association, 2001). This statement is contradicted by all service-user research as well as the findings of SURE (2002) and NICE (2003); indeed, Scott (2005) remarked that NICE took ‘special note of the evidence from users that cognitive impairment after ECT often outweighed their perception of any benefit from it’.

Is it depression?

If the task of assessing amnesia, memory disability and cognitive deficits is left to a patient’s treating psychiatrist, there may be a tendency to attribute all deficits, without evaluation, to depression, even when the patient has fully recovered. The APA guidelines state that

‘Patients with the greatest symptomatic benefit from
ECT typically report the greatest improvement in
subjective evaluations of memory. Thus, when patients
report subjective memory impairment after ECT, their
mood as well as their cognition should be assessed’
(American Psychiatric Association, 2001: p. 72).

It seems that this statement is based on SMQ scores from six studies: Pettinati & Rosenberg, 1984; Weiner et al, 1986; Mattes et al, 1990; Sackeim et al, 1993 and Coleman et al, 1996, which involved the same patients; and Sackeim et al, 2000. On average, patients reported improvement in cognitive functions assessed by the SMQ within 1 week of ECT. However, the following should be taken into account: first, the improvement was relative only to immediate pre-ECT status, not baseline, thus in fact reflecting a net impairment; and second, objective testing revealed that the patients were in fact cognitively impaired post-ECT. There are other studies in which patients reported impairment post- ECT on the SMQ (Squire et al, 1979; Squire & Slater, 1983; Squire & Zouzounis, 1988). To the extent that a handful of studies support a claim of correlation between memory and cognitive self-rating and mood during or immediately after ECT, there might be a correlation between relatively improved memory self-rating and improved mood. There is no evidence of a correlation between impaired memory/cognition after ECT and impaired mood, much less a causal relationship. The problem of premature assessment There are many reasons why hospitalised patients who have received ECT might overestimate their abilities. After each treatment they experience acute organic brain syndrome (Sackeim, 1986). In hospital, they are not exposed to even minimally taxing actions such as shopping and driving. There are no environmental cues as to what they are expected to know and remember in their roles outside the hospital. In a few days or even weeks, patients cannot gain enough experience of using their minds and memories to accurately assess their altered capacities (Weiner et al, 1986; Coleman et al, 1996; Donahue, 2000). In the longer term, i.e. 2-6 months, patients who initially rated their memory and cognition as improved, experience and accurately report impairment (Weiner et al, 1986; Coleman et al, 1996).

More recent work using the SMQ suggests that, in the short term as well, patient ratings of memory function are negative and are correlated with the results of objective tests, even when controlling for the level of depression. These researchers say that patient reports of memory impairment ‘must not be dismissed as being depressive complaints only’ (Schulze-Rauschenbach et al, 2005).

Differentiating the effects of ECT

Although terms such as memory loss are often used interchangeably by clinicians to describe the temporary effects of depression on cognition (especially attention) and the long-lasting effects of ECT on a range of cognitive functions, this confusion is unnecessary and could be avoided. The effects of ECT are quantitatively and qualitatively different from those of depression (Squire et al, 1979) and researchers have consistently distinguished between them (Cronholm & Ottoson, 1963; Squire et al, 1979; Squire & Slater, 1983; Pettinati & Rosenberg, 1984; Squire & Zouzounis, 1988). Numerous controlled studies show that individuals who are depressed but have not had ECT do not suffer amnesia (Janis, 1950;

Weiner et all 1986). People who have experienced the effects of both depression and ECT rarely mistake one for the other (Food and Drug Administration, 1982; Donahue, 2000): ECT’s effects are different and worse, they occur only after ECT and they persist in the absence of depression and drugs.

Possible mechanisms of action

How might ECT cause permanent amnesia and memory and cognitive disability? There are several theories (Box 3). One is that memory is affected because the applied electrical current is densest in the medial temporal area structures associated with memory, including the hippocampus; these areas have low seizure thresholds. However, this has not been studied directly (Calev, 1994).

Other theories focus on ECT’s effects on brain metabolism and neurochemistry: breach of the blood-brain barrier and increased cerebral blood pressure (Bolwig et al, 1977; Taylor et al, 1985); regional increases in T2 relaxation times (Diehl et a!, 1994); disturbance of the long-term potentiation mechanism (Sackeim, 2000; Rami-Gonzalez et al, 2001); excessive release of excitatory amino acids and activation of their receptors (Chamberlin & Tsai, 1998; Rami-Gonzalez et all 2001), and decreased cholinergic transmission (Khan et al, 1993; Rami- Gonzalez et al, 2001). Even temporary alterations in any of these may have permanent effects on the brain.

Since ECT affects both temporal and frontal lobes, it is logical that its effects would not be limited to amnesia, but would involve both memory and non-memory neuropsychological functions (Calev et al, 1995). Sackeim (2000) hypothesises that the traditional view that amnesia results from damage to medial temporal lobe structures alone may be wrong, since it is known both that frontal lobe damage can result in amnesia as extensive as that seen after ECT and that ECT exerts its most profound effects on the prefrontal cortex.

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If this hypothesis holds, then frontal functions must be affected as well as memory. Simply because there has been very little investigation of ECT’s effects on these functions, doctors should not be sanguine as to lack of permanent effects. Absence of evidence is not evidence of absence. In particular, Sackeim (2000) points to the lack of formal research on ECT’s effects on the executive functions of the prefrontal cortex: working memory (holding onto information in the service of a range of cognitive functions), logical reasoning and abstraction, shifting of mental set, problem-solving, planning and organising. These are ‘fundamental to organising one’s life and controlling behavior, yet there has been little investigation of the impact of ECT’ (Sackeim, 2000).

Three trials, two controlled and one small and uncontrolled, support the theory of frontal lobe involvement in functional impairment, although assessments were carried out only during or immediately after ECT (Neylan et al, 2001; Rami- Gonzalez et al, 2003; Schulze-Rauschenbach et al, 2005).

A generation ago, one researcher, reviewing the literature on ECT experimentation, wrote that the ease of its administration has resulted in its widespread use

‘without the usual background information customarily thought appropriate for most treatment modalities o this is undoubtedly the case because of the clinically observed changes in affect and behavior that result from such treatment. While such behavioral observations are certainly fruitful, such a model should be reversed to allow behavioral inferences to the possible effects on neocortical structures of such a procedure’ (Goldstein et al, 1977).


The evidence base

In the absence of long-term follow-up studies over the past two decades, the best available evidence for the permanent effects of ECT on memory ability and cognition has been generated by former patients. This has most often taken the form of patient-designed survey instruments, which ask specifically about cognition. Of the groups whose findings were incorporated into the SURE systematic review, one found that 65% of people who had had ECT reported impaired organisational skills (ECT Anonymous, 1999). Another found that one-third had difficulty concentrating, and 15% reported loss of reasoning ability (Pedler, 2001). A third asked people whether they had experienced a loss of intelligence ‘soon after the treatment’, and about 40% answered affirmatively (they were not asked whether the loss persisted) (Philpot et al, 2004). However, former patients have publicly testified that ECT can result in a very significant (>30 point) permanent decrement in IQ score (Food and Drug Administration, 1982; Andre, 2001; Cott, 2005: p. 5) and have documented the claims by extensive neuropsychological evaluation.

Although surveys and case reports are not rigorous controlled trials, in the absence of such trials conducted months or years after ECT, they provide a basis for inferences as to the treatment’s permanent adverse effects and possible mechanisms of action.

What’s wrong with the way patients have been assessed?

Claims that ECT does not have permanent adverse effects on memory and cognitive ability have been based on extremely gross measures of mental function such as the Mini-Mental State Examination (MMSE; Folstein et al, 1975) and other dementia screening scales (Stoudemire et al, 1993; Sackeim, 2000; McCall et al, 2004). But if ECT had produced wholesale dementia on a scale gross enough to be detected by these tests, it would have been abandoned decades ago.

Researchers have used very simple, brief measures to assess patients – typically, highly structured tests of verbal learning involving familiar material. Examples include the Auditory Verbal Learning Test (AVLT; Rey, 1964) and various forms of paired associates, with very short retention intervals. But there is no evidence that ECT interferes with well- established skills such as vocabulary or with short recall periods (Squire & Chace, 1975; Zervas & Jandorf, 1993).

Even people with severe brain injury or lobotomy can perform well on simple tests of overlearned verbal material that require culturally common information, for example the Wechsler Memory Scale. Highly motivated and concerned ECT patients are even more likely to do well on these tests. However, clinicians who conclude from this that there is ‘no memory loss’ have not measured memory loss at all, and certainly not the type of memory and cognitive disability that people can experience after ECT (National Institute for Clinical Excellence, 2003).

Collectively, the comments of people who have had ECT indicate loss of complex skills that underlie real-world roles such as student, professor, nurse or physicist, and often inability to return to those roles post-ECT (Box 4).

The sensitivity of the tests used after ECT depends largely on whether and how well they reflect actual cognitive demands of the type placed on ex-patients. Researchers have assured patients that ECT has no permanent adverse effects on the basis of the assumption that these demands will be minimal (McCall et al, 2004). But this assumption has never been tested, and patient reports warn against it. The ECT patient population includes people who are in the prime of life, highly educated and involved in demanding professions, and who can be very articulate in describing their deficits. If simple standardised tests cannot detect these deficits, the challenge is not to dismiss their comments but to find or devise more appropriate tests.

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The Autobiographical Memory Interview

Weiner et al (1986) and Sackeim and his colleagues (Coleman et al, 1996; Sackeim et al, 2000) have attempted to measure amnesia with an unvalidated instrument of their own design, known as the (Columbia University) Autobiographical Memory Interview. This test is insensitive to ECT-induced amnesia in two related ways: it measures very old information whereas ECT amnesia is known to be densest for more recent memory; and as many as 60% of the 200-300 test items involve overlearned and highly rehearsed facts – grandparents’ names, telephone numbers of close relatives, etc. – which are not likely to be erased by ECT. The overlearned and the old information may overlap (as in questions such as ‘What is your address’) or it may not, but in either case confounding the testing with these factors will unnecessarily result in an underestimate of the extent of retrograde amnesia.

Furthermore, the Autobiographical Memory Interview assumes that amnesia is limited to events that took place within the 12 months prior to ECT and does not attempt to assess amnesia that is not limited to that time period. However, only about 20% of the questions ask specifically about that year; the rest ask about overlearned personal information (What are your parents’ names? What are the rooms in your house?) or about events that have ‘ever’ happened to patients or their families.

Thus, it is remarkable that even as insensitive an instrument as this has shown extensive permanent retrograde amnesia measured at 2 months (Cole- man et al, 1996) and 6 months (Weiner et al, 1986) after ECT.

Assessment of amnesia

Routine neuropsychological tests are unhelpful in attempting to assess retrograde amnesia (Rose et al, 2003). Squire & Slater (1983) attempted to measure amnesia by asking people who had had ECT to make a time line showing the amount of life lost. The accu- racy of this depends, of course, on the patients’ ability to assess the extent of their amnesia, which can take many years, as they can only discover what they have forgotten when prompted by others to remember it. If asked soon after ECT, they are very likely to under- estimate the extent of retrograde amnesia.

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Because the information stored in memory is unique to each individual, standardised questionnaires or checklists may prove insensitive to amnesia even when the patient can describe or demonstrate it. Janis (1950) interviewed patients before and 1 month after ECT. He suggested general topics but let the patients speak at length. After ECT, he attempted to elicit the same information, but could not. For each individual he could count 10-20 significant life experiences that had been erased that were not limited to the period immediately before the treatment. Even when he prompted patients to recount events they had described in great detail before treatment, they could neither recall nor recognise them. One year after ECT, the amnesias remained stable. The same interviews were given to controls matched in all ways: age, gender, education, duration of hospitalisation, type and duration of mental disorder; the controls, who had not had ECT, had no amnesia.

The Janis test (Janis, 1950) can be done easily and cost-effectively even by those with no special research training. SURE (2002) in particular calls for the replication of this study, as have others over the years. But it has not yet been done.

Assessment of memory and cognitive ability

Tests of memory and cognitive ability must assess a range of functions, because ECT impairment may vary not only between individuals (Goldstein et al, 1977) but within individuals when they undergo more than one course of treatment. Simple tests of rote verbal learning or the memory sub-tests of the Wechsler are not sufficient, since ECT (if the amnesia is not catastrophic) spares vocabulary, overall wealth of knowledge and overlearned verbal skills. Patients who have had ECT should be evaluated with the type of neuropsychological batteries that would be used for patients with a known or suspected history of brain injury. These should include tests of non- verbal and visuospatial memory and reasoning such as those listed in Box 5.

If there are constraints of time and finances, tests should be tailored to the individual’s deficits, which can be identified by narrative self-report and by rating scales such as the Cognitive Failures Questionnaire (Broadbent et al, 1982).
When should patients be tested?

If there is to be baseline testing, compensation must be made to account for the difference between the patient’s true memory and cognitive capacity and the performance when preoccupied by depression, medicated or hospitalised. If such compensation is not made, all a return to ‘baseline’ function after ECT would show would be that ECT’s effects are roughly equal to – although not necessarily the same as – those of depression (Calev et al, 1995).

A better estimation of pre-ECT capacity would be the patient’s history and normal functioning at school, work or in some other capacity. Many patients, at least in the USA, will have had an IQ test, which can be used for comparison with post- ECT scores.

Patients cannot be meaningfully evaluated in hospital during or soon after ECT. Neither self- reports nor crude memory tests may be reliable (Cronholm & Ottoson, 1963). A patient may do well on the MMSE or counting serial sevens but may not know that her friend visited her the day before – and will not know she doesn’t know. Having had no reason theretofore not to trust her memory, and not having been warned to expect severe dysfunction, she will adamantly insist that her memory cannot be faulty. It is not the psychological defence mechanism of denial, nor is it only the acute organic brain syndrome which occurs with ECT, that causes this genuine unawareness. Most patients have never before experienced a day in their life when they did not know what they ate for dinner or who they had seen or what they had read the day before. They do not even know that this is possible, let alone that it is happening to them.

The ECT Accreditation Service (2005) recommends that patients should be interviewed 3 and 6 months after ECT. But at 3 months, they may not have recovered the ability to hold on to day-to-day memories (they may still be within the period of anterograde amnesia, estimated by the US National Institutes of Health (1985) to average 2 months). We propose that follow-up should be no sooner than 6 months. One year allows for optimal stabilisation of permanent cognitive deficits and better assessment of retrograde amnesia.

The Service User Research Enterprise (2002) has called for a research study with ‘long followup because losses of memory prior to ECT may only become apparent after a long interval’, as have Greenhalgh et al (2005: p. 78).

What should patients be told?

Amnesia

The clinician who tells her patients that there is a lack of research on the permanent adverse effects of ECT will certainly be on solid ground; however, this is unlikely to help patients in making a potentially life-altering decision. The best she can do is present her patients with what is known (and not known) and encourage them to assess the risk in light of their personal situation.

Thus, patients can be told that permanent amnesia is one of the ‘common’ (Sackeim, 2000) or ‘serious/ frequently occurring’ (Royal College of Psychiatrists, 2005: p. 207) effects of ECT and that it affects at least one-third of patients (Service User Research Institute, 2002; Rose et al, 2003). Such amnesia may be presented as having multiple dimensions: the amount of life lost, the temporal gradient, the nature of what is lost, and the effect of the memory erasure on the individual’s life.

The amount of life lost to amnesia cannot be predicted; patients should be warned that it has been known to extend to 10-20 years (Pedler, 2001; Service User Research Enterprise, 2002). It should be made clear that amnesia is not limited to information about discrete events or to facts that are easily regained, such as dates and telephone numbers, but that it encompasses all thoughts, feelings, personal interactions and relationships, learning and skills associated with the erased time period, and thus there is no simple or easy way to recapture what is lost. Since the temporal gradient of ECT amnesia is the opposite of normal forgetting, patients should be warned that the most recent months or years will be most affected. When amnesia is permanent it has profound, rarely positive, effects on all aspects of the patient’s subsequent life. For many people the effects of permanent amnesia and/or memory and cognitive disability negate any benefit sustained from ECT (National Institute for Clinical Excellence, 2003).

The College now advises psychiatrists to discuss the topic of retrograde amnesia carefully (Royal College of Psychiatrists, 2005: p. 7). But profound and sudden retrograde amnesia has no parallel in ordinary human experience. Doctors cannot be expected to understand the myriad ways in which permanent amnesia can disrupt one’s life. For this reason, prospective patients should be encouraged to speak with, or read accounts written by, people who have experienced amnesia. Such accounts are contained within the above-mentioned reports of SURE, NICE and MIND (Pedler, 2001), and are widely available in print (e.g. Donahue, 2000) and through online forums, e.g. http://www. ect.org) where prospective patients and families can sometimes ask questions directly of former patients.

Cognitive impairment

The Royal College of Psychiatrists (2005: p. 19) and NICE (2003) advise that the potential for cognitive impairment be highlighted during the consent process. Patients should be clearly told that ECT may have serious and permanent effects on both memory ability and non-memory cognition. These are best described in everyday terms: ‘the ability to plan and organise and get things done’ rather than ‘executive function’.

Intact memory and intelligence are highly prized in our culture. The more valuable a possession, the more important it is to know about even a small chance that it might be permanently lost. Even if the answer to how often IQ is permanently lowered is ‘We don’t know’, that is a material fact to be weighed by the patient. As individuals, patients vary greatly in the demands placed on their intellect and the potential consequences of permanent impairment. The decision to agree to ECT is theirs; the duty to inform, their physician’s.

Conclusions

Evaluation and re-evaluation of ECT’s risks and benefits by SURE, NICE and the Royal College of Psychiatrists, and the growing recognition of the extent and importance of research by and involving people who have experienced ECT, as well as increased interest in qualitative data, should lead to improvement in both patient care and research. In light of alarming findings that 50% of patients report receiving inadequate warnings of the potential side- effects of ECT, informed consent practices need to be revised. In particular, prospective patients should be warned of the significant risk of permanent amnesia and the possibility of permanent memory and cognitive disability. Research to adequately assess the nature and longevity of these effects should be undertaken, ‘incorporating patients’ perspectives on the impact of ECT into future RCTs’ (Greenhalgh et al, 2005: p. 78). By all accounts this is long overdue.

Declaration of interest
None.

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For a commentary on this article see pp. 237-238, this issue.

Harold Robertson (148 Beach 94th St, Suite 6, 3rd Fl., Queens, NY 11693, USA. Email: robertson.harold@gmail.com) is the director of a not-for-profit charitable foundation in New York focusing on the underserved patient population. His interest in psychiatric research, in particular research into the use of electroconvulsive therapy, has brought him into contact with others with similar interests across the globe for the past 20 years. Robin Pryor is a psychologist who has held a private practice in New York, NY, for 30 years. His particular interests are the history of psychiatry and first-person narratives of mental health service users. He writes and lectures on these topics.

ECT in India

ECT (ELECTRO CONVULSIVE THERAPY): NEED FOR DEBATE
Center for Advocacy in Mental Health

A research center of Bapu Trust, Pune, India

INTRODUCTION

The World Health Report, 2001 of the WHO is the most recent among a line of reports and documents suggesting the tremendous increase in the burden of mental disorders in developing regions. Several researchers (for example Patel, 1999) have underscored the “social determinants model” of mental health, where poor social and economic development is linked with increased risk for mental ill health. The poor and vulnerable groups are seen as being at high risk for common mental disorders (CMD). The research of the last decade on gender and mental health has also shown the greater vulnerability of men and women to substance abuse and depression respectively (Davar, 1999; 2001).

Incommensurate with the emerging epidemiological and social science data bases in mental health today, and the increasing awareness in society about mental disorder, there is a large gap in service provision and quality of care research or advocacy. When it comes to service provision, “cost effectiveness”, “risk benefit analysis”, etc. has led to some questionable arguments and conclusions, because of the lack of public debate. Only partisan views prevail in this area and the debate is polarized between medical professionals and human rights groups in mental health.

Two significant arguments made on the basis of cost effectiveness are the following:

(1) That direct ECT (Electro Convulsive Therapy) is the cheapest and most effective form of treatment (Andrade, 2003a, b; Tharyan, et. al. 1993) and

(2) That anti-depressants are better (cheaper and more effective) than placebo or psychological counseling in the treatment of depression (Patel et al 2003).

Both these arguments boost the prominent bio-medical profile and future of mental health provision in India. With a view to starting a public debate on community alternatives and quality of care in mental health service provision, in this paper, we take a position regarding the recent advocacy promoting the use of direct ECT (i.e. shock treatment without anesthesia), as the cheapest, and most effective form of treatment for mental disorders (Andrade, 2003a, b; Tharyan, et. al. 1993).

We argue that direct ECT is a controversial, hazardous and traumatizing procedure. There is no contemporary evidence base for the use of the procedure. There is an uncommon degree of death, injury, terror and trauma caused by the procedure. And finally, there is a high potential for abusing it as a form of punishment. These factors, we conclude, makes direct ECT an instrument of torture, rather than of treatment. The use of the procedure must be brought within human rights jurisprudence and should be the subject of consumer action and litigation. Regulatory bodies such as the IECs, Medical Research Council and the Psychiatric Society should stop further research on direct ECT.

We do admit that families may have obtained beneficial results from use of the ECT when administered well. However, we agree with Pathare (2003) who writes that people friendly, psychotherapeutic and community-based options must be developed instead of routinely prescribing ECT on the basis of the “poor country” argument. The topic of ECT in general and its relevance in community mental health must be more widely debated.

1. ELECTRO-CONVULSIVE THERAPY (ECT): OUT OF THE CLOSET

Finally, the subject is out of the closet. Shock treatment has always been a taboo subject in India. It has been an esoteric topic discussed in medical forums, but never brought up before for public debate. Recently, in the wake of the Supreme Court approval of the procedure, a prominent psychiatrist has written making a case for direct ECT (Andrade, 2003a, b). This article follows in a line of other articles advocating direct ECT in recent times (Tharyan, et al 1993). This resurgence of direct ECT is risky in mental health service provision in India.

1.1 What is ECT?

In ECT, an electrical current of between 70 to 170 volts is passed for between 0.5 and 1.5 seconds. In direct ECT, the body is thrown into frank epilepsy like seizures. While the patient is conscious in the beginning, he or she is rendered unconscious when the grand mal seizure starts. He is held down physically by staff to prevent fractures and internal injuries. The risk of injury is high. As the procedure is usually given in series, this hazard is experienced again and again. In an ideal text book situation, the procedure is repeated between 6 to 10 times. But continuous dosing of up to 20 times or more is neither unknown nor uncommon in India.

In its “modern” or “modified” form (Modified ECT), text book practice suggests that the patient should not eat or drink for four hours or more before the procedure, to reduce the risk of vomiting and incontinence. Medication may be given to reduce the mouth secretions. Muscle relaxants and anesthesia are given to reduce the overt epileptic / muscular convulsions. The muscle relaxant paralyzes all the muscles of the body, including those of the respiratory system. Anxiety may be caused to the patient due to a sense of suffocation and anesthesia is given to prevent the anxiety. General anesthesia is given intravenously to make the patient unconscious. A “crash cart” is kept nearby, with a variety of life-saving devices and medications, including a defibrillator for kick starting the heart in case of a cardiac arrest. The brain is subjected to seizure activity induced by the electrical current, as it is believed that seizure is the essentially curative. The causal mechanism by which the treatment works is not known. Endocrinological, neurotransmitter and other changes have drawn a blank (Kiloh, et al 1988). It is believed that electricity itself and the seizure activity it produces is the curing element.

To get a picture of the procedure, read below, a full narrative of the experience of modified ECT, reported by doctors in 1988:

“In a generalized seizure (grand mal) the patient loses consciousness immediately and the whole musculature goes into a powerful tonic spasm. The upper limbs are held close to the body with flexion of the wrists and fingers, while the lower limbs extend with inversion of the feet and flexion of the toes. The trunk muscles contract and as the extensor muscles are the more powerful the spine tends to become hyperextended. The respiratory muscles are involved so that respiration ceases. The pupils dilate and become inactive and the eyes are insensitive to touch. There is an increase in heart rate and a rise in both systolic and diastolic blood pressure. If the bladder or bowel are distended at the time of the fit, either or both may be evacuated. The tonic phase usually lasts some 10-30 s followed by a partial, brief relaxation of muscles and a swift return of the spasm. Violent jerks then convulse the body in rapid succession and blood-stained froth may exude from the mouth. The clonic jerkings continue, the intervals between them lengthening, until with a final jerk the clonic stage terminates. At this point a degree of cyanosis is usual but after a brief period of flaccidity breathing is re-established. Often as consciousness begins to return, the patient passes into a deep sleep. If this does not occur the patient shows evidence of confusion with disorientation and may talk in a rambling and disjointed manner sometimes with paraphasias. The patient is likely to be restless and may show excited behaviour perhaps becoming irritable, angry and even violent” (Kiloh, et. al. 1988: p. 189).

1.2 Use of ECT in India

Only a few scattered articles exist in India, mostly published in the official journal of the Indian Psychiatric Society (Indian Journal of Psychiatry), on direct ECT practice. Vahia et al’s early study (1974) reported that in Bombay, 10580 patients out of 12,540 were given direct ECT, a large proportion of the help seeking population. Davar (1999) reviewing secondary literature wrote that, unlike the trend in the west, the use of ECT increased 20-fold in a hospital in Mumbai over a decade. Agarwal, Andrade and Reddy (1992) reported that direct ECT is widely practiced in India as a form of psychiatric treatment. Sharma and Chadda’s (1990) review of hospital facilities also showed that a majority of Indian mental hospitals used direct ECT.

Agarwal and Andrade (1997) studied the attitudes of psychiatrists towards ECT. Of 263 respondents 2.7% strongly objected to the procedure and another 9.5% generally opposed. Another 5.3% had no feelings one way or another. 64.3% were generally favourable, another 12.5% were decidedly favourable. 80% of doctors felt that ECT is the safest, cheapest and most effective form of treatment. A fair majority disagreed that ECT should be used when all else failed. The researchers are “reassured that most felt positive towards ECT”.

Professionals claim that patients are overwhelmingly happy about the effects of ECT (Andrade, 2003b). However, there is no experiential or quantified consumer satisfaction research to back this up. Not surprisingly, patient views on ECT are completely missing in the literature. Experiential accounts of staff or doctors, who have administered the procedure, are not available. There are problems, as we will see, about doing such studies. One study done during the direct ECT era (Verghese, Gupta & Prabhu, 1968) reported that not a single patient out of 36, voluntarily opted for ECT. 26 passively submitted, 8 had apprehensions and 2 strongly objected. This study reported memory loss and marked disorientation following the treatment. This is the only consent study we have found reported in literature.

1.3 SC interest in direct ECT

As readers of EPW may be aware, direct ECT has been placed as a controversial and contested issue before the Supreme Court recently. In the month of August, 2001, 28 people labeled with mental illness perished in a fire tragedy in Ramanathapuram district of Tamil Nadu. The manager of the private shelter in Erwadi had kept them tied to their cots, and so, escape was impossible. The SC took suo moto action and ordered all State Governments to file affidavits on a continuing basis, tabling information on the following topics: the availability of services within the state for mental disorders; whether the Mental Health Act has been implemented; the functioning of the State Mental Health Authority (SMHA); information on religious healing sites and whether mentally ill persons have been kept in chains in any part of the state. The SC appointed an amicus curiae to make recommendations, to field relevant information to the court and to process related petitions that may be filed by the public.

Direct ECT is considered a most contested and controversial procedure in the treatment of mental disorders. Saarthak, an NGO working for persons with mental illness in New Delhi, filed a petition before the SC appealing mainly the following: limitations on physical restraint, an unconditional ban on direct ECT and removal of Section (81.2) of the Mental Health Act, which allows proxy consent for research on persons with mental illness (Writ Petition No. 562/2001 in Saarthak vs. Union of India). While noting that ECT is not the top question for discussion in mental health today, Pathare (2003) has written responding to the Saarthak petition: “This debate [direct vs. modified] is a non-starter: it is accepted the world over that ECT must be administered in a modified form. It has been argued that there is a special case for permitting direct ECT in India because of the lack of facilities for anesthesia and to reduce the costs of treatment. Both these arguments are spurious. ECT is a major procedure and must be carried out under reasonably safe medical conditions” (p. 11). Not many professionals have written in response to the SC intervention.

The response of the state and the judiciary to use of direct ECT has however been ambivalent. In response to the SC orders, many states have reported that direct ECT is being phased out and that as per modern practice, only modified ECT is being used. Some states have given a justification for continuing the use of direct ECT, while also certifying that in their State this practice is not being followed.

In their final judgment, the apex court noted that “ECT remains effective in several major mental disorders”. It is “life saving” and reduces the “risk of suicide”. It further states, notoriously, that direct ECT is safer than modified ECT, as in the latter the risk of use of anesthesia and muscle relaxants is added. Dr. D. Mohan, Psychiatrist, AIIMS advised the apex court, in this instance. The doctor observes a mortality rate of “only 0.03%” in direct ECT, considered clinically insignificant, where as with modified ECT risks of use of anesthesia are to be added. Dr Gauri Devi, erstwhile director of NIMHANS, wrote observing mainly that modified ECT is a non-issue in the treatment of certain mental disorders. But she did not frontally address the issue of direct ECT, the central topic of the Saarthak litigation.

The Supreme Court judgment in this regard raises several questions about the interphase between law and science, the responsibility of medical professionals when giving testimony or scientific evidence, and the collective responsibility of the sciences and the judiciary, towards establishing certain standards of quality health care. The AIIMS professional did not give the background database about direct ECT, or explore the controversy surrounding it, even as a matter of informing the court. Instead of treating this as a quality of care issue and as an investigative matter, he “certified” the procedure as safe, raising the concern about questionable authorisation. The court, on its part, considered the certification given by a couple of psychiatrists as sufficient for making a decision. The Saarthak petition with respect to ECT was not treated with the respect that it deserved by the judiciary or by the professional community.

Around the world, in well-developed legal or policy formulations on involuntary commitments for mental illness, there are provisions and sanctions on the use of (modified) ECT. In India, legal or policy instruments in mental health do not address the procedure of ECT. The Mental Health Act, 1987, is about the institutionalization of persons with mental illness through commitment procedures. The Act was formulated in the context of involuntary commitment of persons labelled with mental illness – a reality in mental health care. Involuntary commitment ill automatically cancels the constitutional right of liberty (Dhanda, 2001) and a further law was required to allow this to happen within the law. However, the Act makes no mention at all of ECT, the top notch instrument of involuntary treatment in mental health care.

A few premier mental health institutions in the country have internal guidelines for the practice of ECT within their institution. At a National workshop on ECT in NIMHANS in 1990, members of the Indian Psychiatric Society recommended the use of modified ECT, in the presence of a qualified anesthetist as the norm for clinical practice. In a meeting of the State Health Secretaries in Bangalore in June, 1999, organized by NIMHANS, modified ECT has been recommended. Regulation of direct ECT has happened in some states of India mainly by High Court interventions. The Bombay High Court recommended against the use of direct ECT way back in 1989, following the Mahajan Committee Recommendations. In Goa too, due to legal advocacy and the proactive role of psychiatrists there, direct ECT has been banned (WP (Civil) No. 257, 1998, Collossa vs. State of Goa in the High Court of Mumbai). In Japan, ECT is used, just as in India, without anesthesia (Minkowitz, 2002), often as a type of punishment for political prisoners. Some countries in the Central and South of America continue to use direct ECT, and international human rights organizations are involved in challenging and reforming the practice.

1.4 Status of Direct ECT in the developed world

If we were to ask, “what is the evidence base which will validate the use of direct ECT” it is difficult to find the answer. It is difficult to find materials on direct ECT in world academic journals of the last 30 years. The only “evidence base” cited is the one or two studies done in India itself, Tharyan, et. al.’s eleven year study (1993) being a very significant one. Indian professionals advocating direct ECT will not find international academic journals, which will publish their articles, and so such articles are published in the obscure Indian Journal of Psychiatry. The world professional community considers the procedure of shock treatment without anesthesia, as barbaric and obsolete.

Many European countries including Holland have phased out even modified ECT, with other countries drastically reducing usage. In the US, use of ECT came down by 46% following consumer action between 1975 and 1980. As awareness about quality care and patient self-determination grows in mental health, every “forced ECT” (i.e. modified ECT where patient has not consented) in any part of the US elicits immediate activism, direct consumer action and patient litigation. In the words of LR Frank, who is called the “Gandhi” of mental health activism in the US, “ECT is a brutal, dehumanizing, memory-destroying, intelligence-lowering, brain-damaging, brain-washing, life threatening technique. ECT robs people of their memories, their personality and their humanity. It is a method for gutting the brain in order to control and punish people who fall or step out of line, and intimate others who are on the verge of doing so” (Frank, 2003: p. 17). Several efforts are on to ban the use of even modified ECT, some of them with partial success. The American Psychiatric Association survey of 1978 showed that only 16% of psychiatrists in the US gave ECT. Consumer groups in mental health maintain “Shock Doctor Rosters”, registering and shaming in public all doctors who indiscriminately prescribe shock treatments, and who do not offer a whole range of other psychotherapeutic opportunities.

This is why Dr Andrade’s recent article (2203a), which has set off a recent controversy in Issues in Medical Ethics, is incredibly astonishing and terribly disappointing. The paper does not even place an exclamation mark in making a case for direct ECT. To make a case for direct ECT in today’s context establishes a fresh, new low for psychiatric ethics in India. So, instead of debating the issue of ‘whether or not ECT at all’, and what other people and user-friendly alternatives we can create in mental health, we are placed in this ridiculous situation of debating direct ECT.

2. IMPACT OF DIRECT ECT

Any discussion on direct ECT, as mentioned above, has to draw from literature that is dated by atleast three decades. It is important to ask, why did the developed world ban the practice? Two major effects of direct ECT led to the phasing out of this procedure in the west– One, relating to the death and injury, and second, relating to the terror and the trauma, caused by the procedure on patients. We discuss these two aspects in this section and the next.

2.1 Injury caused by direct ECT

Direct ECT was invented in curious circumstances. The Italian, Ugo Cerletti, was inspired by the fact that electricity was used in preparing pigs for slaughter in an abattoir. They were rendered unconscious by bilateral placement of electrodes and passing current. Convulsions preceded the loss of consciousness. Following much experimentation on the pigs, he and his colleague, Lucio Bini invented the ECT procedure in 1938 when they first induced an artificial convulsion in a man (Kiloh, et. al., 1988). The man in question was a wandering mentally ill person. In 1940s and 1950s ECT use greatly increased, with experimental research on direct ECT holding sway.

Soon the data on death and injury, which started emerging on direct ECT, was alarming enough to lead to a ban on the procedure. 0.5% to 20% reportedly experienced vertebral fractures in use of direct ECT (Wiseman, pp. 118-119). In the UK, what stopped direct ECT was a well-known case, Bolam v. Friern Barnet Hospital Management Committee, when the patient sustained pelvic fracture. The US army forbade use of ECT during World War II in the early days, but with the increasing role of psychiatrists in the military during this time, it was reintroduced in 1943. The “Young Turks” of the nascent American Psychiatric Society railed against the “promiscuous and indiscriminate use of ECT” in 1947.

Professionals claim (Andrade 2000; 2003a; Tharyan et al 1993) that direct ECT is risk free. Infact, the world experience shows that direct ECT is not safe. As Andrade (2003a) himself mentions, reviewing previous research done in the 40s and 50s, direct ECT is associated with risk of vertebral / thoracic fractures, dislocation of various joints, muscle or ligament tears, cardiac arrhythmias, fluid secretion into the respiratory tract, internal tears, haemorrhages and blood letting, other than fear and anxiety. Risks are greater in males, older subjects, pregnant women and those with osteoporosis. Their own study (Andrade et al 2000) had found that “only 2%” of patients (i.e. 1 out of every 50 patients) experienced “an adverse musculoskeletal event with unmodified ECT”. Tharyan, et al (1993) enlist the risks involved in direct ECT: fractures of the spine, femur, humerus, acetabulum, scapula; dislocations of the arm, jaw and hip; rupture of abdominal muscles; fat embolism; rupture or bleeding of internal organs or viscera and increased apprehension. They do not mention cardiac complications and death, both of which their own study reported.

For “evidence base”, Andrade (2003a) cites the earlier study by Tharyan, et al. (1993), advocating direct ECT. First, a single study is not “an evidence base”. Secondly, this study itself needs careful examination. Andrade writes that in this study, only 12 patients experienced fractures out of a total of 1835 patients receiving 13,597 treatments. In the way the data from this study has been re-presented, it sounds as if a few of the patients walked out of the ECT table with a slight twisting of the middle finger. Andrade fails to mention all the relevant data from this study. The fractures that patients had during this study were thoracic / vertebral fractures involving almost a third of the body vertebrae. The sudden onset of convulsions has a crushing impact on the bones. The neurological disabilities and other orthopaedic consequences of these spinal injuries are unknown. Andrade also fails to mention that in this study, there was one reported death due to cardiac arrest (i.e. one patient out of 1835 died), a good percentage experienced body aches, both local and generalised, and another one percent of the patients had cardiac complications. These data, especially the high rate of spinal injury and mortality rate, which from the patient point of view seem horrific, are not considered “clinically significant” by the authors of this study. Absent, the professional standards for refusing any practice in psychiatry, there does not seem any other way of contesting this data except by throwing up your hands in horror.

Table 1: Complications. Click for larger view.

table.jpg

Source: Kiloh, et. al. (1988: pp.254-266) “True side effects” refers to inevitable events that always accompany ECT; “Complications” refers to infrequent but not rare events accompanying ECT; “risks” refers to unlikely events accompanying ECT; and “complaints” refers to the physical or somatic complaints associated with ECT. It must be highlighted that with modified ECT, such events are “less likely” but not completely ruled out.

2.2 Death due to ECT
The recent APA Task Force on ECT (2001) notes that contrary to earlier evidence, they have to now acknowledge that mortality rates with ECT (modified) may be as high as 1 in 10,000 patients. Consumers (Frank, 2002) say that mortality rates may be as high as 1% with modified ECT. The mortality rates are probably higher among the elderly. The Task Force report also notes that 1 in 200 will experience irretrievable memory loss, a fact hitherto dismissed as irrelevant by the medical fraternity.

Death in the case of ECT is usually due to cardio-vascular or cerebral-vascular complications, followed by respiratory failure. Shukla (1985), in discussing a case report of death following modified ECT, reviews the mortality data associated with the procedure. Rates between 0.8% and 0.003% have been reported in the western literature. Shukla, finding it a curious fact that deaths have not been reported at all in the Indian professional literature, observes that fatalities are not always publicly reported, particularly in India, but every psychiatrist would have experienced such cases in his practice.

3. DIRECT ECT AS TRAUMA
Leo Frank, an ex-patient subjected to many years of insulin treatment and direct ECT, says, “Why is it that 10v of electricity applied to a political prisoner’s private parts is seen as torture, while 10 or 15 times that amount applied to the brain is called “treatment”?” (2002, p. 19). Many human rights instruments around the world cover the area of the psychiatric system also, as medical coercion and violence, the loss of liberty, political abuse and being incarcerated through misuse of the criminal justice system is high in this health care sector. Involuntary commitment, patient consent, restraint and limits to coercive treatment are covered in human rights jurisprudence because of the fact that this constituency is particularly at risk for loss of constitutional rights. The UN Principles of 1991 also enlists fundamental rights and freedoms of psychiatric patients, and right to quality health care, as such explicit protection is seen as necessary for this vulnerable population. The Council of Europe came out with a White Paper (2000) on “protection of rights” of mentally ill patients and the Convention for Prevention of Torture (2002) also covers involuntary commitment. The ICCPR also covers the rights of institutionalized patients. As the label of mental disorder literally deletes personhood, such human rights safe guards are seen as necessary.

In India, we do not have human rights instruments covering the fundamental rights and freedoms of psychiatric patients. (The Mental Health Act, even though it has a human rights chapter, makes some general statements on such rights such as “no cruelty”). Such instruments are necessary because such patients are the most vulnerable within the community and risk abuse and civil rights violation on a daily basis (Dhanda, 2001).

In developing this instrument, use of direct ECT must be enlisted as a type of torture and as a human rights violation, as found in other world conventions. The European CPT (Convention for the Prevention of Torture) 2002 prohibits the use of direct ECT as a form of torture. The Convention says: “The CPT is particularly concerned when it encounters the administration of ECT in its unmodified form; this method can no longer be considered as acceptable in modern psychiatric practice. ECT should always be administered in a modified form” (Chapter VI, Section 39). One of the reasons cited by the CPT for prohibition on direct ECT is the terror experienced by patients during and after the procedure. The White paper (2000) on the “Protection of the human rights and dignity of people suffering from mental disorder, especially those placed in a psychiatric establishment” drafted by the Working Party of the Steering Committee on Bio Ethics (CDBI), Council of Europe, also prohibits the use of direct ECT.

3.1 Mental effects of direct ECT
Nearly all patients suffer amnesia about the period around which they were given ECT. People given ECT do not remember the experience itself and are not able to report on what it felt like to be given an ECT. In fact, this is a good reason why getting patient experiences of ECT is near impossible: As in trauma, the memories about the experience itself are not available to the conscious mind. Why does memory get wiped out, is a question that all concerned people have been grappling with for a long time. Earlier, professionals used to actually believe that brain damage is curative. We have also heard the clich? that “why would patients want to remember painful memories about mental disorder”, mistakenly suggesting that such memories were wiped out selectively. Advocates against the procedure argue that since it traumatizes the brain, memories are wiped out.

Direct ECT, as a treatment procedure, causes several disruptive psychological effects (Wiseman, 1995). Patient stories show that loss of memory and concentration are common. This affects personal lives (loss of cherished memories), and job performance (technical or mathematical memory, which can be the basic skill for engineers, lawyers or accountants can be lost). Artistic abilities can be lost. Because of this, there is the risk of having to do mechanical unskilled jobs, be unemployed, lose relationships, etc. Confusion, self-doubt due to the loss of memory, uncertainty, increased helplessness, loss of ability to learn and unlearn, lethargy, loss of ability in cognitive subjects will be experienced by many. Suicide and increased violence has also been associated following the use of ECT.

It is common experience in India, too, that patients are terrified of ECT. Within institutional settings, taking someone for ECT is experienced as a punishment by the patients. There is an undercurrent of humilation, shaming and punitive action in the use of the procedure within institutional contexts. Few patients, even those who actually find it beneficial, escape the sense of rage and humiliation that the procedure evokes. As direct ECT is very much like what is crudely shown on bollywood films, the fear and apprehension is quite understandable.

Direct ECT, in the medical narratives, comes across as any other stimulus, which freezes a person in terror, fear and pain. The terror associated with the procedure is a sign of trauma, and not a sign of insanity. As Breggin writes, ECT evokes raw survival fears to the fore. Even the highest experts on ECT (Abrams, et al pp. 130-131) have written that organic brain syndrome to varying degrees is common following all ECTs. ECT may affect all aspects of the brain system including thoughts, feelings and behaviours. EEG abnormalities may not go away for several months or years following ECT, indicating continuing brain seizure activities and possible brain damage. Other psychiatric experts write: “What cannot be denied is that transient forms of brain dysfunction, sometimes of considerable severity, occur with the Cerletti-Bini technique [direct ECT] particularly in elderly patients” (Kiloh, et. al., 1988: p. 190). The most evident effect of ECT on the brain was the vegetativeness of the patient, and reduction in his motor abilities. In fact, psychiatrists of yore believed that temporary brain damage effects the “cure” of mental illness (p. 213).

Direct ECT was described even in doctor’s narratives as somewhat close to lobotomy, the surgical removal of a portion of the frontal brain. Early doctors who gave direct ECT expected “regression”, a state when the patient was meek and submissive, wetting or soiling themselves, whimpering and crying easily, like a child. A writer in the Diseases of the Nervous System wrote, in 1951: “By the end of this intensive course of treatment practically all 52 patients showed profound disturbances. All showed incontinence of urine, and incontinence of feces was not uncommon. Most of them were underactive and did not talk spontaneously. Many failed to respond to questions but a few patients would obey simple requests. They appeared prostrated and apathetic. At the same time, most of them whined, whimpered and cried readily, and some were resistant and petulant in a child like way” (Wiseman, pp.118-119). The suggestion in literature is that ECT affects the limbic system of the brain, the same system that is affected by deep trauma.

In the UK, following the famous case against direct ECT, there was also a general consensus among professionals and policy makers that its unpleasant effects gave more scope for it to be used as a punishing tool, and several such stories did emerge until the 1980s. Case after case indicates that ECT is made as a choice of treatment in the case of “unmanageable” patients. ECT quiets the patients and remits agitation immediately, for unknown reasons. Within institutional contexts, therefore, the risk of abuse of the procedure is high. In India, although there is negligible documentation, direct ECT has been used as a punishment by families in collusion with psychiatrists against errant daughters and given to cure “naxalism” (Ramaswamy, 1999). For many years, the writer has suffered irretrievable memory loss. ECT has been given in India for all and sundry problems, including “curing” homosexuality. The use of direct ECT for dealing with political prisoners in Japan is also known (Minkowitz, 2002).

3.2 Use of sedation to allay fear
The fear associated with direct ECT is equal to the fear caused by any instrument of punishment and torture, and it is not a sign of insanity. It is the prejudicial attitude of professionals towards persons with mental illness, which allows them to interpret every response to their treatment as a symptom warranting further abusive treatment. With this logic, it will never be possible for a patient diagnosed with mental illness, to ever raise a question about the treatment they receive, for all such questions will risk being interpreted as a “psychiatric symptom”. Infact, Peter Breggin (1993), an erstwhile psychiatrist who gave up the profession in disgust over its abusive practices, and joined the mental health consumer movement as a researcher and a social scientist, wrote that the most dangerous impact of ECT was that the patient is no longer in a position to protest the damage done to him (p. 240). This strategy of seeing patient refusal of a particular treatment, as symptomatic behaviour, is evident in Tharyan et al’s study as well, which we discuss below. Such attitudes diminish the self determination of the patient in his or her own care.

In Tharyan et al’s opinion fuelling study, too, a high percentage of patients (7.5%) reported fear and apprehension of the procedure, and 50 patients actually refused the treatment. On ordinary ethical conditions of doing human behavioural research, we assume that such subjects would have been allowed to drop out of the study. How did the researchers proceed with this frightened sample of 150 patients?

Well, they did so, by actually sedating them and getting them to comply. Quoting them in full: “A fifty of them [patients] refused further ECT due to this fear while in the remainder (100 patients) the fear was reduced by sedative premeditation enabling them to complete the course of ECT. In the earlier half of the decade under review, barbiturates, oral diazepam, parenteral haloperidol and even thiopentone were used to allay anxiety; in recent years, this has been effectively managed by pretreatment with 1 to 4 mg of lorazepam given orally”. Further, it was interesting for these authors to observe that those who refused ECT were not among those who were sedated, that is, most of those sedated complied.

Such is the prejudicial approach to mentally ill patients, that refusal of a hazardous and life-threatening procedure is considered as a mere symptom, and further treated with sedatives to obtain patient compliance. We are of course aware of other power situations, such as rape or wife battery, when refusal is treated as consent. Tharyan et al’s study also suggests that it is common practice to sedate patients who refuse ECT. Amazingly, in their list of recommendations, they recommend the use of sedatives to minimize the fear of ECT among the patients. Their political message seems to be that, if people refuse a hazardous treatment, or if they will not participate in research that involves study of such a treatment, then it is okay sedate them. Patient ethics fundamentally rests on the principle of autonomy, which is seriously violated with this approach.

The world data of three decades already exists to rule out the procedure as barbaric. No further research is necessary on direct ECT. And if over six decades of ECT research has come up with little hard data on the causal effects of its beneficence, except the vague claim that electricity itself causes the cure, then perhaps it is time to question the assumption of its value in mental health service provision. Andrade recommends systematic sampling and interviewing of patients who have received ECT, as “dissatisfied patients can be found for all treatments?” (pp. 44-45). This call for quantified survey data on patient experience of direct ECT is against the very basis of human rights jurisprudence, where a single case of violation is indeed representative.

Because of the physical and mental trauma caused by the procedure, patients given direct ECT must be considered as victims of torture and the perpetrators of this form of torture must be brought within human rights jurisprudence. Direct ECT research should not be allowed to happen in future, as this would be a clear human rights violation. Statutory authorities, institutional ethics committees and consumer bodies must ask explanations regarding the recent highly objectionable research done on direct ECT.
4. WHY DIRECT ECT
The main argument used by Tharyan, et al (1993), Andrade (2003) and others is that direct ECT is “cost-effective”. The dogma among professionals is that direct ECT is the cheapest and safest form of treatment for mental disorder, as it does not require medical facilities and an anesthetist. It is argued that in a resource poor setting, we have to compare “existing alternatives”, use the cheapest means available for cure, and not go for the most ideal (modified ECT). If the choice were between no ECT and direct ECT, then direct ECT is considered to be the more “ethical” alternative in the treatment of mental disorders. We question these arguments in this last section.

4.1 ECT is not a cure

Andrade (2003b) argues that:

“From an emotional perspective, a seizure-inducing treatment could certainly seem barbaric. However, if ECT is barbaric or unattractive, so too are cardioversions, abortions, Caesarean sections, radical mastectomies, open heart surgeries, orthopaedic and neurosurgical interventions, and so where does one draw the line?” (p. 44)

It is misleading to compare ECT with major surgery in justifying usage. Surgery intends to cure. But ECT is palliative, not curative. This means that in practice, professionals use it repeatedly as and when they like as, palliative care being an ongoing need, unlike curative care. Infact, relapse rate has been reportedly high in the use of ECT for schizophrenia and patients have to go for ECT “like an addiction”, in the words of someone who has experienced the treatment. Within the span of a week or two, mastectomies or open heart surgeries are not prescribed in series. It would incredibly impoverish families and patients, if this were so. The text book prescribes 6 to 10 sessions of ECT, unlike the case of surgery. If we wish to adopt the surgery metaphor, then, ideally, the procedure would be used as a last resort. However, ECT is used often as the first line of treatment for dealing with mental disorders in India. Over-prescription is the rule rather than the exception. In the cost-effectiveness argument, are such realities of practice taken into account?

Finally, the stout evidence base underlying surgery is simply not comparable to the very weak epistemological foundations of ECT. Mental sciences in general suffer from weak epistemologies (Davar and Bhat, 1995) when compared to the natural sciences. Professionals cannot say how ECT works. Neurotransmitter and endocrinological studies have drawn a blank (Kiloh, et al 1988), and all that can be said is that electricity itself cures.

4.2 Training for direct ECT
Tharyan, et al’s study (1993) reassures the reader that in giving direct ECT, “trained” professionals were used to give direct ECT. What does “training” mean in the context of giving direct ECT? You just need some physically very strong people to tie down the patient in strategic points and to keep the jaw and joint areas from major injury. [If we were to include direct ECT in our community mental health, NGO training or volunteer training programs, what kind of programs will we have to run? Training Programs on "Accident management during ECT", "Bone setting and suturing course for ECT managers", "Martial arts and body techniques for CHWs giving direct ECTs", etc. seem appropriate titles.]

However that may be, in Tharyan et al’s study (1993), the composition of the full “trained team” used to prevent injury were the following: four orderlies, three nurses, two postgraduate trainees and a consultant psychiatrist, that is, a total of 10 “trained” people! If cost-effectiveness is our preferred parameter for “ethically” choosing a particular option, wouldn’t it be just cheaper to hire an anesthetist? It is unrealistic that in the actual settings where direct ECTs are going to be used, for example, the district hospital or the private clinic, there would be so many “trained” people to audit the ECT procedure. The research situation was an ideal situation, unlike the practice situation. Even here, with a full load of 10 people tying down a patient from the convulsions, the reported injury rate was not insignificant.

Another aspect of cost is highlighted by Kiloh, et. al. (1988) (who in general approve of ECT as a sound treatment in some cases). They cite studies of patients wherein, following ECT, the depressive symptoms remitted immediately, but they had to stay in the hospital for a week to clear their “confusion, memory loss, euphoria, lability of mood and affect, and impaired judgement” (p. 251). In the case of direct ECT, we can expect that the costs of injury, illhealth and disability are higher. We wonder if these costs have been factored into the dogma about the cost-effectiveness of direct ECT.
4.3 ECT is lucrative
While we question the faith that direct ECT is cost effective for the patient, we suspect that it is lucrative for the doctor. In the US (Wiseman, 1995; Kiloh et al 1988), ECT research is conducted by very few organizations. Large research, medical foundations and psychiatric learned societies do not fund ECT research. The medical fraternity looks down upon the procedure. The government does not fund ECT research, and it is not often used in the federal, and state hospitals. However, this trend may be changing with the recent American Psychiatric Association’s approval of the procedure.

In India, ECT is lucrative business. It falls within specialist practice. In nearly every city in India, a majority of psychiatrists practice privately and give ECT in their private clinics. In Pune city for example, nearly 90% of psychiatrists are in private practice, with the public mental health system having become literally dysfunctional. They cater mainly to the middle class with fees ranging between 100 rupees to 500 rupees per consultation. A recent survey in western India showed that nearly 80% of private psychiatrists give ECT, costing anywhere between 500 to 1000 rupees per dosage. If we set the dosage at textbook level (i.e. 6 to 10 ECTs), the total cost would be anywhere between 3,000/= to 10,000/= rupees per series. Direct ECT is a money-spinner for many psychiatrists in the business. There are unscrupulous psychiatrists who ask the patient to first take an ECT before even consultation (Bapu workshop, 2002)!

4.4 Policy regulation absent
In India, ECT is given without restriction for anything and everything, often as first line of treatment, for even “curing” homosexuality. Andrade (2003a) writes that ECT is given to catatonic, suicidal, or otherwise “highly disturbed” patients. To say that “highly disturbed” patients can be given ECT allows too much ambiguity and scope for abuse of the procedure. In the direct ECT era, Shukla (1974) recommended use of direct ECT as a solution for passing a nasal tube to catatonic patients who refuse food: “At times it is very difficult to pass a tube even under sedation. I have tried the following in such patients with a 100% success: I give the patient direct ECT. (There are no problems as these patients are usually fasting and their stomach, bowel and bladder are empty). As soon as the convulsions stop and the patient is in a flaccid state, I pass the tube and it goes in very easily” (p. 95).

Policy guidelines and evidence base repeatedly comes up with only one diagnosis where ECT may be tried if other treatments fail- that is in the case of endogenous depression. Some documents do say that in this case, modified ECT can also be tried as first line of treatment, but enlist further conditions, including patient consent, an active audit program in each ECT department. The CPT 2002 also talks about patient consent and ECT audit, including a registry of ECT.

Reviews of research on the use of ECT in the case of schizophrenia upto the mid ’80s, when ECT research was at its peak, shows that
1. It is not possible to be emphatic about the value of ECT in patients diagnosed with schizophrenia
2. ECT and neuroleptic drugs have the same outcomes statistically
3. The relapse rate is high in use of ECT, showing that it probably has short term benefits

On the basis of the review, Kiloh et al (1988) observe that “the question whether the long-term effects of neuroleptic drugs, notably tardive dyskinesia, are more or less disabling than the possible ill effects of long term ECT cannot be answered” (p. 244).

ECT guidelines do not exist in India, making it a huge ethical issue among patients and consumers. Indian psychiatrists recognize the cavalier use of ECT. Agarwal (1990) in his editorial notes remarkable deficiencies in the administration of ECT even in the West, writing, “the situation in India is bound to be more disappointing”. ECT in India is often prescribed in series, without any review, the conditions for safe use and correct use are not specified, the staff giving ECT are often untrained, and physical pre-exam is often not done, as it is felt that ECT is safe for anyone and everyone (“virtually no contradictions”, according to the psychiatric dogma).

Patient consent:
The community mental health program in India (NMHP, 1982) promises to take mental health services to the community. Unfortunately, in most parts of India, it has remained a drug and ECT dispensing service, with minimal understanding or engagement with the community. The advocacy for direct ECT is likely to increase misuse of ECT in private practice and in the community mental health programs. Lack of awareness among communities about this procedure is likely to be harvested by unscrupulous professionals. As people with mental illness are not considered fit to give consent, patient consent is rarely addressed. In many hospitals, patients and their families are only told that they are receiving an “injection”, as it is argued that patients will not understand the procedure. Consent letters, if used at all, are signed on that basis. See, for example, the narrative below.

“In the beginning my husband did not benefit from the medicine, so he had to be given shots. And while giving shots also they take [the patient] with great love and affection, not that they tied and took him. They will lure you and take you. There are two or three employees. Those who try to run, they have to be stern with them. Even for shots? because there is a danger that perhaps they may die? attention has to be paid even to their teeth that they should not dislocate or fall. When shots are administered the teeth is clenched and it clatters? the entire jaw may even come out, so they put a big bandage inside. If it moves, the entire set both can come out in that bandage. They would tell you before hand that you keep either milk or tea ready.”

Quality of care
The research cited in this paper advocating direct ECT was done under ideal treatment conditions. The institutions where the research was conducted (NIMHANS, CMC) were well funded public health institutions, with a promise of high quality care. Adequate staff were allocated for the research. Under ideal conditions, the injury rate is not insignificant, as we have argued above. What can we expect from less than ideal conditions? We give a case study below:

“Meena” was imprisoned in a Maharashtra jail for killing her sister. She suffered from “voices in the head” for several years. After the accident, she was arrested and then taken for treatment. Here we present a portion of her experiences with shock treatment without anesthesia:

“I was totally maddened by this time. The police arrested me and kept me in the lock-up. I felt very remorseful after that. They later took me to a nearby famous hospital. There they gave me shock treatments. 4 shocks they gave me with anaesthesia and three shocks they gave me without anaesthesia. I remember feeling those three shocks while I was awake. I had not fainted, and could feel the shocks. It was extremely painful. They used not to give me any tea in the morning either. I would not allow them to put the cloth in my mouth. It was extremely painful. I suffered an enormous amount. It was the most horrible pain in my head. I don’t remember anything else about the time. I was also very rude with the doctors. The voices in my head stopped after that. I kept feeling remorseful about how I had killed my auntie’s only child. My aunty came to visit me in hospital also. I asked her whether she had told the doctors to give me shocks. She didn’t know anything about it. I was unconscious for 3 days after the shocks. It was very traumatic.”
We have all experienced the mundane pain of needles poking at our elbow because the poorly trained staffer “could not find a vein”. What are the effects of poorly administered direct ECT? The patient is rendered unconscious only when the grand mal seizure starts at a particular electrical threshold. Meena was probably given ECT without anesthesia at infra-threshold, so she did not become unconscious.

4.5 Other guidelines
Recently, in Utah, an ECT Bill passed by the House is being considered by the Senate in which consumer groups have had a large role to play. The proposed bill (www.le.state.ut.us/-2003/htmdoc/hbillhtm/HBO109S1.htm) does the following: It prohibits shock for children under the age of 14. It prohibits shock for individuals who are committed against their will. It prohibits a legal guardian to consent to shock for someone else. It requires a second medical opinion to shock someone over the age of 65. It requires that informed consent mentions that possible side effects of shock may include permanent memory loss, cardiac arrest and death. It requires a reporting system to show how many are shocked every year and if they suffer from any side effects within a certain amount of time. It requires that an autopsy be done if someone dies after shock, and that the autopsy look for brain damage by searching for destroyed small blood vessels. It allows free individuals over the age of 18 to receive shock after they get full informed consent.

The Royal College of Psychiatrists Commission Guidelines give conditions for anesthetic equipment, the ECT machine, staff requirements and treatment protocols. As direct ECT machines are obsolete, such machines would be ruled out by international standards. The FDA considers ECT machines as “Class III” devices, that is “hazardous”.

There is a need to investigate the condition and commerce of existing ECT machines in India, who makes these machines, who approves them, what are the standards for the machines. In UK, an internationally recognized advocate of ECT, Dr Abrams, who wrote the very popular reference book, Electroconvulsive Therapy, was found to be one of the two member Board of Directors of Somatics, a commercial venture involving ECT machine manufacture and sale. Half his yearly income was drawn from Somatics. While not making allusions to possibility or ethics of the commercial interests of any professional in the practice, we are indeed suggesting that the commerce of ECT needs to be more thoroughly investigated.

The National Mental Health Association, the largest non-profit mental health organization in the US, issued a public statement on the 11th of June, 2000. The statement says that the NMHA recognizes that ECT is a controversial procedure and that although it may have beneficial results, it also involves serious risks. It has urged the increased, rigorous and objective research, as well as dissemination of such research, on ECT especially from the safety point of view. The organization also supported the position that ECT recipients must be informed of all the pros and cons and have access to all kinds of information to be able to make fully informed decisions. NMHA further recommends that “ECT be presented as an alternative with extreme caution, only after all other treatment approaches have either failed or have been seriously and thoroughly evaluated and rejected” (www.nmha.org/position/ps31.crm).

CONCLUSION: THE NEED FOR PUBLIC DEBATE
There must be a public debate on the issue of the use of ECT in India. Most world data bases of the last decade, culminating in WHO’s World Health Report, 2001, have highlighted the phenomenal “increase” in the “burden” of mental disorders in developing countries. The spin-offs of globalisation and economic reform, (including debts, ethnic violence, poverty, homelessness, displacement and cultural loss) have resulted in the greater mental ill health of vulnerable groups. Poverty and mental disorder are being linked in a significant way in the literature. Meanwhile, there has been little challenge to the privatization of mental health and little is known about the influence of drug companies on the development of research, technology and service within the sector.

Advocating direct ECT against the background of the Indian reality of a questionable mental health care quality can be risky. Andrade writes that “if the risk-benefit ratio favours the treatment, and if the treatment is better than existing alternatives, in the interest of the patient the treatment must survive” and that “unmodified ECT may be preferable to no ECT” (2000b:p.44). The fact of not having created interesting and humane alternatives in mental health has been the pathos of the Indian mental health service system. It is disappointing that this fact should lead to advocacy of direct ECT, instead of fuelling the creation of imaginative psycho-therapeutic and community models. On the basis of the argument that India is a “poor” country and the poor need quick alternatives, justifications have also existed for various invasive and undignified “treatments”, such as mass sterilization, and hysterectomies, in the case of the mentally challenged girls.

Background to the paper
The ideas presented here are the result of several discussions in our Center by Aparna Waikar, Bhargavi Davar, Chandra Karhadkar, Darshana Bansode, Deepra Dandekar, Seema Kakade, Sonali Wayal, and Yogita Kulkarni. Bhargavi Davar did the research for this paper. Deepra Dandekar and Darshana Bansode submitted a case study from the “Archives” team of our Center, from their documentation of the plight of mentally ill women prisoners in Maharashtra. The community narrative on ECT as “injections” came from our “Needs Assessment Study of NGOs in mental health”. Fieldwork was done by Lalita Joshi and Seema Kakade for this study. Our activities are funded by Sir Dorabji Trust and Action Aid India.

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.Agarwal, A.K. (1990) “ECT: A need for re-appraisal”. Editorial. Indian Journal of Psychiatry, 32(4) pp.295-296.
.Agarwal, A.K. and Andrade, C. (1997) “Indian psychiatrists’ attitudes towards electroconvulsive therapy”. Indian Journal of Psychiatry, 39(1), pp. 54-60.
.Agarwal, A.K., Andrade, C. and Reddy, M.V. (1992) “The practice of ECT in India. Issues relating to the administration of ECT”. Indian Journal of Psychiatry, 34(4), pp. 285-297.
.Andrade, C. (2003a) “Unmodified ECT: Ethical Issues”, Issues in Medical Ethics, Vol. 11 Issue 1, pp. 9-10.
.Andrade, C. (2003b) “ECT: A measured defence”, Issues in Medical Ethics, Vol. 11 Issue 2.
Andrade, C., Rele, K., Sutharshan, R., Shah, N. (2000) “Musculoskeletal morbidity with unmodified ECT may be less than earlier believed”, Indian Journal of Psychiatry, 42, pp. 156-162.
.APA Task Force on ECT (2001)
.Breggin, P. (1993) Toxic Psychiatry: Drugs and ECT, The Truth and the Better Alternatives. Harper Collins.
.Clinical Resource and Audit Group (CRAG) Working Group on Mental Illness (1997) Electroconvulsive Therapy (ECT): A Good Practice Statement. Edinburgh: CRAG.
.CPT, (2002) European Committee for the Prevention of Torture and Inhuman or degrading treatment or punishment, CPT – 2002, Chapter VI- Involuntary Commitment, Section 39 – ECT. Council of Europe.
.Davar, BV (1999) Mental health of Indian women. A feminist agenda. Sage Publications, New Delhi.
.Davar, B.V. (2001) Mental health from a gender perspective. Sage: New Delhi.
.Davar, B.V. & Bhat, P.R. (1995) Psychoanalysis as a human science: Beyond foundationalism. Sage: New Delhi.
.Dhanda, A. (2001) Legal order, mental disorder. Sage Publications, New Delhi.
Frank, LR 2003, “Electroshock: A crime against the spirit”, In a Nutshell, Fall/Winter 2002-2003, pp. 16-22.
.Kiloh, L.G., Smith, J.S., Johnson, G.F. (1988) Physical treatments in Psychiatry. Foreword by Sir Martin Roth. Blackwell.
.NIMHANS (1999) “Recommendations of national workshop for State Health Secretaries”, June 7th, 8th, Bangalore.
.Patel, V. (1998) Culture and Common Mental Disorders in Sub-Saharan Africa. UK: Psychology Press.
.Patel, V., Chisholm, D., Rabe-Hesketh, S., Dias-Saxena, F., Andrew, G. and Mann, A. (2003) “Efficacy and cost-effectiveness of drug and psychological treatments for CMD in GHC in Goa, India: A randomized, controlled trial”. Lancet, Vol. 361, pp.33-39.
.Pathare, S. (2003) “Beyond ECT”. Issues in Medical Ethics, XI(1) Jan-Mar, pp. 11-12
Royal College of Psychiatrists (1995) The ECT Handbook (Second Report of the Royal College of Psychiatrists’ Special Committee on ECT). Council Report CR39. London: Royal College of Psychiatrists.
.Shukla, G.D. (1985) “Death following ECT- A case report”, Indian Journal of Psychiatry, Vol. 27, Issue 01, pp. 95-97.
.Task Force Reports (1978, 1990, 2001) on ECT. American Psychiatric Association, USA.
.Tharyan, P., Saju, P.J., Datta, S., John, J.K., Kuruvilla, K. (1993) “Physical morbidity with unmodified ECT: a decade of experience”, Indian Journal of Psychiatry, 35, Issue 4, pp. 211-214.
.UN General Assembly Resolution No. 46/119, 17-12-1991. “Principles for the Protection of persons with Mental Illness”, United Nations.
.Vahia et al’s early study (1974)
.Verghese, Gupta & Prabhu, 1968)
.White paper (2000) on the “Protection of the human rights and dignity of people suffering from mental disorder, especially those placed in a psychiatric establishment” drafted by the Working Party of the Steering Committee on Bio Ethics (CDBI), Council of Europe.
.Wiseman, B. (1995) Psychiatry: The ultimate betrayal. Freedom Publishing Co. A Publication of Citizens Commission for Human Rights, LA, California.
.World Health Report, (2001) Mental Health. World Health Organisation, Geneva.
.WP (Civil) No. 257, 1998, Collossa vs. State of Goa in the High Court of Mumbai.
.Writ Petition No. 562/2001 in Saarthak vs. Union of India in the Supreme Court of India.

NICE report on ECT

Full report from the UK on the usage of ECT. 2003

Note that the use of ECT in schizophrenia, based on the evidence, is not recommended. Someone might want to send the clue train to New York state hospitals.

Download:

59ectfullguidance.pdf (pdf)

SCI Resolution Against Electroshock

Note: This anti-shock resolution is the official position of Support Coalition International (SCI). The final draft was passed by the Board of Directors on July 28,2001. The Resolution can be found on these websites: www.MindFreedom.org, and www.ect.org

RESOLUTION AGAINST ELECTROSHOCK – A CRIME AGAINST HUMANITY

The Board of Directors of Support Coalition International unanimously and strongly condemns the psychiatric procedure of electroshock (“electroconvulsive therapy”,”ECT”) as a serious human rights violation. It is our informed opinion, based on common sense, personal experience and scientific knowledge, that electroshock is a crime against humanity. It directly violates section 5 of the United Nations Universal Declaration of Human Rights which outlaws “cruel, degrading and inhumane treatment or punishment”, and the UN Convention Against Torture. It is our informed opinion that electroshock constitutes cruel and unusual punishment. We also believe that virtually all electroshock is forcibly administered – that is, without genuine, fully informed consent.

We want electroshock abolished for these reasons:

1. Electroshock always causes brain damage.

2. Electroshock always causes permanent memory loss.

3. Electroshock always causes learning disabilities and other intellectual impairments.

4. Electroshock often arouses fear or terror in patients.

5. Even by conventional psychiatic standards, electroshock has an extremely high relapse rate – over 70% within one year.

6. Electroshock does not significantly relieve “depression” or prevent suicide. In fact, several research studies indicate that electroshock can aggravate or trigger depression and suicide attempts: the Nobel Prize-winning author Ernest Hemingway killed himself shortly after undergoing a second series of electroshock.

7. Psychiatrists frequently violate the ethical-legal principle of informed consent when prescribing/ordering electroshock. Subjects are not informed or misinformed about the procedure’s harmful effects. Nor are they informed about humane, non-injurious, non-medical approaches such as counselling (including peer counselling), self-help groups, and life-style changes.

8. Electroshock discriminates against highly vulnerable people. Its chief targets are women and the elderly. Children are also being subjected to electroshock in growing numbers. In the United States and Canada, more than 70% of electroshock is administered to women, and upwards of half of those undergoing electroshock are 60 years of age and older.

9. Electroshock machines have never been independently inspected or approved for their medical safety. Since 1978, the Food and Drug Administration of the United States government has officially placed shock machines in its most dangerous medical-device category: class III, ” hazardous” or “unsafe”.

10. Electroshock has caused many deaths. Such deaths are routinely minimized or under-reported in the medical-psychiatric literature. Rarely are psychiatrists or ECT facilities required to report electroshock-caused deaths, or any other information concerning their use of ECT to governmental regulatory bodies.

Board of Directors
Support Coalition International

SEAN – Scottish ECT Audit Network report

The National Audit of ECT in Scotland:

Executive Summary

The National Audit of ECT in Scotland was ambitious in its aims, seeking to answer questions about clinical practice, facilities and staffing, training and clinical efficacy. Yet it tried to remain practical by attempting to introduce incremental changes into normal clinical activity. Through involving all the clinical team at ECT (doctors, anaesthetists and nurses) and encouraging local site ownership of results the audit sought to produce improvements in practice which will be maintained in the long term.

The audit was divided into three phases and provided a detailed examination of the practice of ECT in Scotland. Against pre-set national standards (with reference to the Royal College of Psychiatrists’ Handbook and the CRAG Good Practice Statement on ECT) two audit loops measured the standard of facilities, equipment, staffing, training and supervision; two audit loops measured clinical outcome; and one measured nursing levels. At the end of Phase 3 a further six months funding was secured in order to establish a mechanism for ongoing data collection.

The views of a wide group of people including users and representatives were sought at an early stage and input from them was very valuable in planning the project. No one member of this Reference Group has signed up to all the statements made and the report itself may not reflect the views of every member.

The audit was designed to gather basic facts about facilities, staffing, use of ECT and outcome. Some of the more controversial questions raised, for example: the validity of the consent process, long term relapse rates and measurement of side effects have been outwith the scope of this project and will only be answered by further research work. We hope that the interest generated by this audit will result in such research being undertaken.

Main results

  • Between 1st August 1997 and 30th April 1998, 872 courses of ECT were given to 794 patients. The average number of ECT treatments per course was 6.8.
  • Between 1st August 1998 and 30th April 1999, 752 courses of ECT were given to 717 patients. The average number of ECT treatments per course was 6.6.
  • During the survey period treatment was given at the rate of 21.2 courses of ECT to 19.7 patients per 100,000 population per year.
  • This represents an annual rate of ECT in Scotland of 142 ECT treatments per 100,000 population. (155 in 1997/98; 130 in 1998/99).
  • ECT was given mainly to white adult in-patients suffering from depressive illness.
  • The ratio of female to male patients was approximately two to one.
  • 76% of patients in the audit were informal (voluntary) patients and 81.8% of all patients gave informed consent to the course of treatment.
  • There was a definite clinical improvement with treatment in 71.2% of those treated for a depressive illness and 65% of those treated for other (psychotic) illnesses.

Key Findings and Conclusions

  • The national audit has involved all ECT centres in Scotland. Meetings involving ECT co-ordinators and user groups have been well attended and general awareness remains high. The audit was on the whole well received and its methodology has now begun to be integrated into clinical practice.
  • The standard of ECT treatment in Scotland has been found to be high. This compares with results from a smaller audit of ECT in England and Wales which revealed disturbing deficiencies in the quality of treatment.
  • Facilities and equipment at ECT centres are up to date and of a generally high standard.
  • The rate of use of ECT in Scotland is comparable with the lowest figures from previous British audits.
  • The higher figure for use of ECT in females reflects the higher incidence of female admissions for depressive disorder (F:M = 1.6: 1 in Scottish Health Statistics 1998).
  • There was no evidence that male psychiatrists prescribed ECT preferentially to female patients.
  • ECT was not given disproportionately to the elderly.
  • The ethnic minorities make up 1.25% of the Scottish population and therefore the figure of 0.7% receiving ECT is well below the population norm.
  • The audit standards set for clinical improvement following ECT were met.
  • ECT is not effective for everyone but the number of patients whose symptoms became worse during the audit was less than would be expected without any intervention.
  • The quality of audit data received was significantly higher from those centres employing an ECT nurse specialist.
  • Issues of consent have been highlighted and clarified. The audit has proved to be a useful sounding board for The Mental Welfare Commission in their development of new guidelines on consent issues related to ECT.
  • The areas highlighted for improvement are mainly related to the ongoing supervision of trainee doctors which correlates with the lack of co-ordinator sessional time.

Download SEAN full report (PDF)

Review of Consumers’ Perspectives on Electro Convulsive Therapy – SURE

The SURE – Service User Research Enterprise – report on consumer views in the UK.

Download PDF file (1.2 mb) consumerperspectives.pdf

APA Task Force Report on Electroconvulsive Therapy

The Practice of Electroconvulsive Therapy:
Recommendations for Treatment, Training and Privileging
Second Edition (Completely Revised)

A Task Force Report of the American Psychiatric Association

Task Force on Electroconvulsive Therapy
Richard D. Weiner, M.D., Ph.D., Chair
C. Edward Coffey, M.D.
Laura J. Fochtmann, M.D.
Robert M. Greenberg, M.D.
Keith E. Isenberg, M.D.
Charles H. Kellner, M.D.
Harold Sackeim, Ph.D.
Louis Moench, M.D., Assembly Liaison

APA Staff: Harold Alan Pincus, M.D.
Laurie E. McQueen, M.S.S.W.

NOTE: The contributors have worked to ensure that all information in this book concerning drug doses, schedules, and routes of administration is accurate at the time of publication and consistent with the standards set by the U.S. Food and Drug Administration and the general medical community. As medical research and practice advance, however, therapeutic standards may change. For this reason and because human and mechanical errors sometimes occur, we recommend that readers follow the advice of a physician directly involved in their care or the care of a member of their family.

The findings, opinions, and conclusions of the report do not necessarily represent the views of the officers, trustees, or all members of the American Psychiatric Association. Each report, however, does represent the thoughtful judgment and findings of the task force of experts who composed it. These reports are considered a substantive contribution to the ongoing analysis and evaluation of problems, programs, issues, and practices in a given area of concern.

The Practice of Electroconvulsive Therapy:
Recommendations for Treatment, Training and Privileging
Second Edition (Completely Revised)

A Task Force Report of the American Psychiatric Association

Task Force on Electroconvulsive Therapy
Richard D. Weiner, M.D., Ph.D., Chair
C. Edward Coffey, M.D.
Laura J. Fochtmann, M.D.
Robert M. Greenberg, M.D.
Keith E. Isenberg, M.D.
Charles H. Kellner, M.D.
Harold Sackeim, Ph.D.
Louis Moench, M.D., Assembly Liaison

APA Staff: Harold Alan Pincus, M.D.
Laurie E. McQueen, M.S.S.W.

NOTE: The contributors have worked to ensure that all information in this book concerning drug doses, schedules, and routes of administration is accurate at the time of publication and consistent with the standards set by the U.S. Food and Drug Administration and the general medical community. As medical research and practice advance, however, therapeutic standards may change. For this reason and because human and mechanical errors sometimes occur, we recommend that readers follow the advice of a physician directly involved in their care or the care of a member of their family.

The findings, opinions, and conclusions of the report do not necessarily represent the views of the officers, trustees, or all members of the American Psychiatric Association. Each report, however, does represent the thoughtful judgment and findings of the task force of experts who composed it. These reports are considered a substantive contribution to the ongoing analysis and evaluation of problems, programs, issues, and practices in a given area of concern.

TABLE OF CONTENTS

Appendix B

Consent forms and sample information patient information

Chapter 1. Introduction

Chapter 2. Indications for Use

Chapter 3. Contraindications and situations of high risk

Chapter 4. Use of ECT in special populations
* 1. Medically Ill
* 2. Elderly
* 3. Pregnancy
* 4. Children and Adolescents
Chapter 5. Adverse Effects

Chapter 6. Pre-ECT evaluation

Chapter 7. Concurrent medication

Chapter 8. Consent

Chapter 9. Staffing

Chapter 10. Location, equipment, supplies

Chapter 11. Treatment Procedures
1. Determination of inpatient and outpatient setting
2. Preparation of the patient
3. Airway management
4. Medications used with ECT
5. ECT devices
6. Stimulus electrode placement
7. Stimulus dosing
8. Physiological monitoring
9. Management of Missed, Abortive, and Prolonged Seizures
10. Postictal Recovery Period
11. Frequency and Number of Treatments
12. Multiple Monitored ECT Chapter 12. Evaluation of Outcome
1. Therapeutic response
2. Adverse Effects
Chapter 13. Continuation/maintenance treatment

Chapter 14. Documentation

Chapter 15. Education and Training in ECT

Chapter 16. Privileging in ECT

Credits

Chapter 1. INTRODUCTION

In 1990, the American Psychiatric Association (APA) published the first edition of The Practice of Electroconvulsive Therapy: Recommendations for Treatment, Training, and Privileging, a comprehensive set of recommendations for the practice of electroconvulsive therapy (ECT). This work was well received and influenced clinical practice in a number of meaningful ways, including the encouragement of guideline development by other groups within the U.S. (Fink et al. 1996) and elsewhere (Royal Australian & New Zealand College of Psychiatrists 1992; Royal College of Psychiatrists 1993; Gangadhar 1995). In the ensuing decade, the field of ECT has continued to advance, with a substantial amount of new scientific and clinical information forthcoming. Each year, hundreds of relevant publications have appeared, as interest in this treatment modality continues to expand.

Because of this growing knowledge base, APA gave the Task Force on ECT a mandate to undertake an update of this report. This revision has been an extensive process. A review of the available clinical literature included a search of all clinical citations related to ECT published between 1989 and 1998 that had been entered into the Medline database by December 1998. Supplementing, this literature review were suggestions received at a Task Force workshop at the 1996 APA Annual Meeting, and after subsequent presentations at Annual Meetings of the Association for Convulsive Therapy (ACT), as well as via informal input from experts and other interested parties. The Task Force’s efforts were made known to the APA membership on an ongoing basis through published summaries of component activities and by notification of the APA Assembly.

To help ensure that these recommendations would be clinically useful, as well as scientifically, ethically, and legally sound, the Task Force sought input from a large number of professional organizations (covering the fields of psychiatry, anesthesiology, nursing, nurse anesthesia, and psychology), individual experts in related areas (including child, adult, and geriatric psychiatry, neurology, psychology, anesthesiology, cardiology, obstetrics, medical ethics, and law), regulatory bodies (Joint Commission on Accreditation of Healthcare Organizations [JCAHO] and the Food and Drug Administration [FDA]), and major lay mental health organizations (see Appendix A). As the initial draft of the revised document neared completion, an article was published in Psychiatric News (the APA newspaper) soliciting the names of additional members with an interest in reviewing the draft. This request ensured that rank and file practitioners would also have the opportunity to have input. Finally, the APA’s own internal review process ensured that drafts were examined from a wide variety of perspectives. Input from these diverse sources was taken into account in the determination of the final product.

This revised volume offers a set of recommendations to assist practitioners and facilities in the safe and effective use of ECT. We have once more attempted to make the scope of the recommendations as comprehensive as possible, including coverage of the important issues of education, training, and privileging. In each section, recommendations are preceded by applicable background information, including pertinent literature citations(with a particular focus on recent work). This format differs from that of the original report, in which background information was placed in a separate Rationale section that was preceded by an overall Recommendations section. The goal of this change in format was an improved integration of the recommendations with their justification. As before, a Bibliography and Appendices provide additional source material of use to practitioners. Due to the growing importance of defined policy and procedure statements in clinical practice, an example of such a document is provided in Appendix E [not present in this Draft] and is designed to be in conformance with these recommendations. While it is not possible to highlight all the changes from the original volume, Appendix F [not present in this Draft] contains a list of major substantive differences between the present recommendations and those made in the 1990 volume.

Over the past 60 years, the practice of ECT has evolved into a complex procedure about which much has been learned, but many questions remain. In providing a comprehensive set of recommendations, it was necessary to include material based up on empirical findings as well as clinical consensus for those situations where well controlled clinical trials are either unavailable or not applicable. It was also apparent that in some cases reasonable alternative courses of action to those presented in these recommendations exist, and attempts have been made to describe a number of such alternative, where applicable. For these reasons, these recommendations should be viewed as suggestions rather than requirements.

In writing recommendations for a complex procedure such as ECT, it is impossible to cover all situations or deal with all possible exceptions. Accordingly, there will be times when overriding factors will lead a reasonable and prudent practitioner to alter practice from that recommended here. In addition, new clinically relevant information is continually appearing, and should be readily incorporated into clinical practice whenever it is shown to either maximize efficacy or minimize adverse effects.

To aid the practitioner in weighing the importance of individual recommendations, we have distinguished between recommendations that we believe are critical to the delivery of safe and effective treatment from those that we believe to be of lesser importance. The categorical term “should” is used to designate crucial recommendations, whereas other recommendations are described in more equivocal terms such as “encouraged,” “suggested,” “recommended,” or “considered”.

As a final caveat, the practitioner should be aware that legal regulations exist regarding ECT, particularly concerning informed consent procedures (see Chapter 8 ). These regulations vary considerably among jurisdictions and over time. Consequently, these recommendations may not always be compatible with all requirements of present or future statutes. Accordingly, practitioners should seek out information on applicable regulations before beginning practice of ECT and should be aware of substantive statutory changes as they unfold.

We encourage practitioners and trainees in psychiatry as well as those in related disciplines to read this document and to integrate its recommendations into their clinical practice. It is designed to offer a comprehensive yet practical overview of the safe and effective use of ECT, with recommendations that should be applicable across a wide spectrum of clinical settings.

Chapter 2: 2.1. Indications for Use

Convulsive therapy has been in continuous use for more than 60 years. The clinical literature establishing its efficacy in specific disorders is amongst the most substantial for any medical treatment (Weiner and Coffey 1988; Mukherjee et al. 1994; Krueger and Sackeim 1995; Sackeim et al. 1995; Abrams 1997a). Like other medical treatments, various sources of evidence support the efficacy of ECT in specific conditions. The indications for ECT have been defined by randomized controlled trials comparing ECT to sham interventions or treatment alternatives and similar trials comparing modifications of ECT technique. The indications for ECT have also been supported by reports of uncontrolled clinical series, case studies, and surveys of expert opinion.

The decision to recommend the use of ECT derives from a risk/benefit analysis for the specific patient. This analysis considers the diagnosis of the patient and the severity of the presenting illness, the patient’s treatment history, the anticipated speed of action and efficacy of ECT, the medical risks and anticipated adverse side effects, and the likely speed of action, efficacy, and safety of alternative treatments.

2.2. Referral for ECT

2.2.1. Primary use. There is considerable variability among practitioners in the frequency with which ECT is used a first-line or primary treatment or is only considered for secondary use after patients have not responded to other interventions. ECT is a major treatment in psychiatry, with well defined indications. It should not be reserved for use only as a “last resort.” Such practice may deprive patients of an effective treatment, delay response and prolong suffering, and may possibly contribute to treatment resistance. In major depression, the chronicity of the index episode is one of the few consistent predictors of clinical outcome with ECT or pharmacotherapy (Hobson 1953; Hamilton and White 1960; Kukopulos et al. 1977; Dunn and Quinlan 1978; Magni et al. 1988; Black et al. 1989b, 1993; Kindler et al. 1991; Prudic et al. 1996). Patients with longer duration of current illness have a reduced probability of responding to antidepressant treatments. The possibility has been raised that exposure to ineffective treatment or to a longer duration of episode actively contributes to treatment resistance (Fava and Davidson 1996; Flint and Rifat 1996).

The likely speed and efficacy of ECT are factors that influence its use as a primary intervention. Particularly in major depression and acute mania, substantial clinical improvement often occurs soon after the start of ECT. It is common for patients to manifest appreciable improvement after one or two treatments (Segman et al. 1995; Nobler et al. 1997). In addition, the time to achieve maximal response is often more rapid than that with psychotropic medications (Sackeim et al. 1995). Besides speed of action, the likelihood of obtaining significant clinical improvement is often more certain with ECT than with other treatment alternatives. Therefore, when a rapid or a higher probability of response is needed, as when patients are severely medically ill, or at risk to harm themselves or others, primary use of ECT should be considered.

Other considerations for the first-line use of ECT involve the patient’s medical status, treatment history, and treatment preference. Due to the patient’s medical status, in some situations, ECT may be safer than alternative treatments (Sackeim 1993, 1998; Weiner et al. in press). This circumstance most commonly arises among the infirm elderly and during pregnancy (see Sections 6.2 and 6.3). Positive response to ECT in the past, particularly in the context medication resistance or intolerance, leads to early consideration of ECT. At times, patients will prefer to receive ECT over alternative treatments, but commonly the opposite will be the case. Patient preferences should be discussed and given weight prior to making treatment recommendations.

Some practitioners also base a decision for primary use of ECT upon other factors, including the nature and severity of symptomatology. Severe major depression with psychotic features, manic delirium, or catatonia are conditions for which there is a clear consensus favoring early reliance on ECT (Weiner and Coffey 1988).

2.2.2. Secondary use. The most common use of ECT is in patients who have not responded to other treatments. During the course of pharmacotherapy, lack of clinical response, intolerance of side effects, deterioration in the psychiatric condition, the appearance of suicidality or inanition are reasons to consider the use of ECT.

The definition of medication resistance and its implications with respect to a referral for ECT have been the subject of considerable discussion (Quitkin et al. 1984; Kroessler 1985; Keller et al. 1986; Prudic et al. 1990; Sackeim et al. 1990a, 1990b; Rush and Thase 1995; Prudic et al. 1996). At present there are no accepted standards by which to define medication resistance. In practice, when assessing the adequacy of pharmacological treatment, psychiatrists rely upon factors such as the type of medication used, dosage, blood levels, duration of treatment, compliance with the medication regimen, adverse effects, nature and degree of therapeutic response, and type and severity of clinical symptomatology (Prudic et al. 1996). For example, patients with psychotic depression should not be viewed as pharmacological nonresponders unless a trial of an antipsychotic medication has been attempted in combination with an antidepressant medication (Spiker et al. 1985; Nelson et al. 1986; Chan et al. 1987). Regardless of diagnosis, patients who have not responded to psychotherapy alone should not be considered treatment resistant in the context of referral for ECT.

In general, failure of patients with major depression to respond to one or more antidepressant medications trials does not preclude a favorable response to ECT (Avery and Lubrano 1979; Paul et al. 1981; Magni et al. 1988; Prudic et al. 1996). Indeed, compared to other treatment alternatives, the probability of response to ECT among patients with medication-resistant depression may be favorable. This is not to say, however, that medication resistance does not predict clinical outcome of ECT. Patients who have not responded to one or more adequate antidepressant medication trials have a lower probability of responding to ECT compared to patients treated with ECT without having received an adequate medication trial during the index episode (Prudic et al. 1990, 1996; Shapira et al. 1996). In addition, medication-resistant patients may require particularly intensive ECT treatment to achieve symptomatic improvement. Consequently, the bulk of patients who fail to benefit from ECT are likely to also be patients who have received, and not benefited from, adequate pharmacotherapy. The relationship between medication resistance and ECT outcome may be stronger for tricyclic antidepressants (TCAs) than for selective serotonin reuptake inhibitors (SSRIs) (Prudic et al. 1996).

2.3. Major Diagnostic Indications

2.3.1. Efficacy in major depression. The efficacy of ECT in depressive mood disorders is documented by an impressive body of research, beginning with the open trials of the 1940s (Kalinowsky and Hoch 1946, 1961; Sargant and Slater 1954); the comparative ECT/pharmacotherapy trials of the 1960s (Greenblatt et al. 1964; Medical Research Council 1965); the comparisons of ECT and sham-ECT, both in the 1950s and in the more recent British studies (Freeman et al. 1978; Lambourn and Gill 1978; Johnstone et al. 1980; West 1981; Brandon et al. 1984; Gregory, et al. 1985; see Sackeim 1989 for a review); and the recent studies contrasting variations in ECT technique (Weiner et al. 1986a, 1986b; Sackeim et al. 1987a; Scott et al. 1992; Letemendia et al. 1991; Sackeim et al. 1993).

While ECT was first introduced as a treatment for schizophrenia, it was quickly found to be especially effective in patients with mood disorders, both in the treatment of depressive and manic states. In the 1940′s and 1950′s, ECT was a mainstay in the treatment of mood disorders, with response rates between 80-90% commonly reported (Kalinowsky and Hoch 1946; Sargant and Slater 1954). The results of these early, largely impressionistic studies have been summarized by the American Psychiatric Association (1978), Fink (1979), Kiloh et al. (1988), Mukherjee et al. (1994) and Abrams (1997a).

Post (1972) suggested that prior to the introduction of ECT, elderly patients with depression often manifested a chronic course or died of intercurrent medical illnesses in psychiatric institutions. A number of studies have contrasted the clinical outcome of depressed patients who received inadequate or no biological treatment to that of patients who received ECT. While none of this work used prospective, random assignment designs, the findings have been uniform. ECT resulted in decreased chronicity and morbidity, and decreased rates of mortality (Avery and Winokur 1976; Babigian and Guttmacher 1984; Wesner and Winokur 1989; Philibert et al. 1995). In much of this work, the advantages of ECT were particularly pronounced in elderly patients. For example, in a recent retrospective comparison of elderly depressed patients treated with ECT or pharmacotherapy, Philibert et al. (1995) found that at long-term follow-up rates of mortality and significant depressive symptomatology were higher in the pharmacotherapy group.

With the introduction of the TCAs and monoamine oxidase inhibitors (MAOIs), random assignment trials were conducted in depressed patients in which ECT was used as the “gold-standard” by which to establish the efficacy of the medications. Three of these studies involved random assignment and blind ratings, and each found a significant therapeutic advantage for ECT over TCAs and placebo (Greenblatt et al. 1964; Medical Research Council 1965; Gangadhar et al. 1982). Other studies also reported ECT to be as or more effective than TCA (Bruce et al. 1960; Kristiansen 1961; Norris and Clancy 1961: Robin and Harris 1962; Stanley and Fleming 1962; Fahy et al. 1963 ); Hutchinson and Smedberg 1963; Wilson et al. 1963; McDonald et al. 1966; Davidson et al. 1978) or MAOIs (King 1959; Kilo et al. 1960; Stanley and Fleming 1962): Hutchinson and Smedberg 1963; Davidson et al. 1978). Janicak et al. (1985), in a meta-analysis of this work, reported that the average response rate to ECT was 20% higher when compared to TCAs and 45% higher than MAOIs.

It should be noted that standards for adequate pharmacological treatment have changed over the decades (Quitkin 1985; Sackeim et al. 1990a), and that, by current criteria, few of these early comparative trials used aggressive pharmacotherapy in terms of dosage and/or duration (Rifkin 1988). In addition, these studies usually focused on depressed patients who were receiving their first biological treatment during the index episode. More recently, in a small study, Dinan and Barry (1989) randomized patients who did not respond to monotherapy with a TCA to treatment with ECT or the combination of a TCA and lithium carbonate. The ECT and the pharmacotherapy groups had equivalent efficacy, but the TCA/lithium, combination may have had an advantage in terms of speed of response.

No studies have compared the efficacy of ECT with newer antidepressant medications, including the SSRIs or medications such as bupropion, mirtazapine, nefazadone, or venlafaxine. However, no trial has ever found an antidepressant medication regimen to be more effective than ECT. Among patients who are receiving ECT as a first-line treatment, or who have received inadequate pharmacotherapy during the index episode due to intolerance, response rates continue to be reported in the range of 90% (Prudic et al. 1990, 1996). Among patients who have not responded to one or more adequate antidepressant trials, the response rate is still substantial, in the range of 50-60%.

The time to achieve full symptomatic improvement with antidepressant medications is typically estimated as 4 to 6 weeks (Quitkin et al. 1984, 1996). This delay until response may be longer in older patients (Salzman et al. 1995). In contrast, the average ECT course for major depression consists of 8-9 treatments (Sackeim et al. 1993; Prudic et al. 1996). Thus, when ECT is administered at a schedule of three treatments per week, full symptomatic improvement usually occurs more rapidly than with pharmacological treatment (Sackeim et al. 1995; Nobler et al. 1997).

ECT is a highly structured treatment, involving a complex, repeatedly administered procedure that is accompanied by high expectations of therapeutic success. Such conditions may augment placebo effects. Given this concern, a set of double-blind, random assignment trials were conducted in England during the late 1970′s and 1980′s that contrasted ‘real’ ECT with ‘sham’ ECT – the repeated administration of anesthesia alone. With one exception (Lambourn and Gill 1978), real ECT was found consistently to be more efficacious than sham treatment (Freeman et al. 1978; Johnstone et al. 1980; West 1981; Brandon et al. 1984; Gregory et al. 1985; see Sackeim 1989 for a review). The exceptional study (Lambourn and Gill 1978) used a form of real ECT, involving low stimulus intensity and right unilateral electrode placement, that is now known to be ineffective (Sackeim et al. 1987a, 1993). Overall, the real vs. sham ECT studies demonstrated that the passage of an electrical stimulus and/or the elicitation of a generalized seizure were necessary for ECT to exert antidepressant effects. Following the randomized acute treatment period, the patients who participated in these studies were free to receive other forms of acute or continuation treatment, including ECT. Consequently, information regarding the duration of symptomatic improvement with real versus sham treatment could not be obtained in this research.

Finally, there have been a host of studies in the treatment of major depression that have contrasted variations in ECT technique, manipulating factors such as stimulus waveform, electrode placement, and stimulus dosage. An important practical observation that emerged was that the efficacy of ECT is equivalent regardless of the use of sine wave or brief pulse stimulation, but that sine wave stimulation results in more severe cognitive impairments (Carney et. al. 1976; Weiner et al. 1986a; Scott et al. 1992). More critical in establishing the efficacy of ECT was the demonstration that the clinical outcome with ECT is dependent on electrode placement and the stimulus dosage (Sackeim et al. 1987a. 1993). These factors can dramatically impact on the efficacy of the treatment, with response rates varying from 17% to 70%. This work went beyond sham-controlled studies, since the forms of ECT that differed markedly in efficacy all involved electrical stimulation and the production of a generalized seizure. Thus, technical factors in ECT administration can strongly influence efficacy.

Prediction of response. ECT is an effective antidepressant in all subtypes of major depressive disorder. Nonetheless, there have been many attempts to determine whether particular subgroups of depressed patients or particular clinical features of depressive illness have prognostic value with respect to ECT’s therapeutic effects.

In the 1950′s and 1960′s, a series of studies showed impressive power to predict clinical outcome in depressed patients on the basis of pre-ECT symptomatology and history (Hobson 1953; Hamilton and White 1960; Rose 1963; Carney et al. 1965; Mendels 1967; see Nobler & Sackeim 1996 and Abrams 1997a for reviews). This work is now largely of historical interest (Hamilton 1986). While the early research emphasized the importance of vegetative or melancholic features as prognostic of positive ECT outcome, recent studies restricted to patients with major depression suggest that subtyping as endogenous or melancholic has little predictive value (Abrams et al. 1973; Coryell and Zimmerman 1984; Zimmerman et al. 1985, 1986; Prudic et al. 1989; Abrams and Vedak 1991; Black et al. 1986; Sackeim and Rush 1996). It is likely that the early positive associations were due to the inclusion of patients with “neurotic depression” or dysthymia in the sampling. Similarly, the distinction between unipolar and bipolar depressive illness has generally been found to be unrelated to therapeutic outcome (Abrams and Taylor 1974; Perris and d’Elia 1966; Black et al. 1986, 1993; Zorumski et al. 1986; Aronson et al. 1988).

In recent research a few clinical features have been related to ECT therapeutic outcome. The majority of studies that have examined the distinction between psychotic and nonpsychotic depression found superior response rates among the psychotic subtype (Hobson 1953: Mendels 1965a, 1965b: Hamilton and White 1960; Mandel et al. 1977; Avery and Lubrano 1979: Clinical Research Centre 1984; Kroessler 1985; Lykouras et al. 1986; Pande et al. 1990; Buchan et al. 1992; see also Parker et al. 1992: Sobin et al. 1996). This is of particular note given the established inferior response rate in psychotic or delusional depression to monotherapy with an antidepressant or antipsychotic medication (Spiker et al. 1985; Chan et al. 1987; Parker et al. 1992). To be effective, a pharmacological trial in psychotic depression should involve combination treatment with an antidepressant and an antipsychotic medication (Nelson et al. 1986; Parker et al. 1992; Rothschild et al. 1993; Wolfersdorf et al. 1995). However, relatively few patients referred for ECT with psychotic depression are administered such combination treatment in sufficient dosage and duration to be considered adequate (Mulsant et al. 1997). Multiple factors may be contributory. Many patients cannot tolerate the dosage of antipsychotic medications generally viewed as necessary for an adequate medication trial in this subtype (Spiker et al. 1985 Nelson et al. 1986). Patients with psychotic depression commonly have severe symptomatology, and are at increased risk for suicide (Roose et al. 1983). The rapid onset and high probability of improvement with ECT makes this treatment of particular value for these patients.

Several studies have also noted that, as with pharmacological treatment, patients with long duration of current episode are less likely to respond to ECT (Hobson 195 Hamilton and White 1960; Kukopulos et al. 1977; Dunn and Quinlan 1978; Magni et al. 1988; Black et al. 1989b. 1993; Kindler et al. 1991; Prudic et al. 1996). As already discussed, the treatment history of patients may provide a useful predictor of ECT outcome, with patients who have failed one or more adequate medication trials showing a substantial, but diminished, rate of ECT response (Prudic et al. 1990, 1996). In the majority of relevant studies patient age has been associated with ECT outcome (Gold and Chiarello 1944; Roberts 1959a, 1959b; Greenblatt et al. 1962; Nystrom 1964; Mendels 1965a, 1965b; Folstein et al. 1973; Stromgren 1973; Coryell and Zimmerman 1984: Black et al. 1993). Older patients are more likely to show marked benefit compared to younger patients (see Sackeim 1993, 1998 for reviews). Gender, race and socioeconomic status do not predict ECT outcome.

The presence of catatonia or catatonic symptoms may be a particularly favorable prognostic sign. Catatonia occurs in patients with severe affective disorders (Abrams and Taylor 1976; Taylor and Abrams 1977), and is now recognized in the DSM-IV as a specifier of a major depressive or manic episode (APA 1994). Catatonia may also present as a consequence of some severe medical illnesses (Breakey and Kala 1977; O’Toole and Dyck 1977; Hafeiz 1987), as well as among patients with schizophrenia. The clinical literature suggests that regardless of diagnosis, ECT is effective in treating catatonic symptoms, including the more malignant form of “lethal catatonia” (Mann et al. 1986, 1990; Geretsegger and Rochawanski 1987; Rohland et al. 1993; Bush et al. 1996).

Major depression which occurs in individuals with preexisting psychiatric or medical disorders is termed “secondary depression.” Uncontrolled studies suggest that patients with secondary depression respond less well to somatic treatments, including ECT, than those with primary depressions (Bibb and Guze 1972; Coryell et al. 1985; Zorumski et al. 1986; Black et al. 1988, 1993). Patients with major depression and a co-morbid personality disorder may have a reduced probability of ECT response (Zimmerman et al. 1986; Black et al. 1988). However, there is sufficient variability in outcome with ECT that each case of secondary depression must be considered on its own merits. For example, patients with post-stroke depression (Murray et al. 1986; House 1987; Allman and Hawton 1987; deQuardo and Tandon 1988, Gustafson et al. 1995) are believed to have a relatively good prognosis with ECT. Patients with major depression superimposed on a personality disorder (e.g. Borderline Personality Disorder) should not be denied ECT out of hand.

Dysthymia as the sole clinical diagnosis has been rarely treated with ECT. However, a history of dysthymia preceding a major depressive episode is common and does not appear to have predictive value with regard to ECT outcome. Indeed, recent evidence suggests that the degree of residual svmptomatology following ECT is equivalent in patients with major depression superimposed on a dysthymic baseline, i.e., “double depression”, and in patients with major depression without a history of dysthymia (Prudic et al. 1993).

Patient features, such as psychosis, medication resistance, and episode duration, only have statistical associations with ECT outcome. This information may be considered in the overall risk/benefit analysis of ECT. For example, a patient with a nonpsychotic, chronic major depression, who has failed to respond to multiple robust medication trials may be less likely to respond to ECT than other patients. Nonetheless, the probability of response with alternative treatments may be still lower, and the use of ECT justified.

2.3.2. Mania. Mania is a syndrome that, when fully expressed, is potentially life-threatening due to exhaustion, excitement, and violence. The early case literature first suggested that ECT is rapidly effective in mania (Smith et al. 1943; Impastato and Almansi 1943; Kino and Thorpe 1946). A series of retrospective studies comprised either naturalistic case series or comparisons of outcome with ECT to that with lithium carbonate or chlorpromazine (McCabe 1976; McCabe and Norris 1977; Thomas and Reddy 1982; Black et al. 1986; Alexander et al. 1988), Stromgren 1988; Mukherjee and Debsikdar 1992). This literature supported the efficacy of ECT in acute mania, and suggested equivalent or superior antimanic properties relative to lithium and chlorpromazine (see Mukherjee et al. 1994 for a review). There have been three prospective comparative studies of clinical outcome of ECT in acute mania. One study primarily compared ECT with lithium treatment (Small et al. 1988), another study compared ECT with combined treatment with lithium and haloperidol (Mukherjee et al. 1988. 1994), and in patients receiving neuroleptic treatment, one study compared real and sham ECT (Sikdar et al. 1994). While each of the prospective studies had small samples, the findings supported the conclusion that ECT was efficacious in acute mania, and likely resulted in superior short-term outcome than the comparison pharmacological conditions. In a review of the English language literature, Mukherjee et al. (1994) reported that ECT was associated with remission or marked clinical improvement in 80% of 589 patients with acute mania.

However, since the availability of lithium and anticonvulsant and antipsychotic medications, ECT has generally been reserved for patients with acute mania who do not respond to adequate pharmacological treatment. There is evidence from the retrospective and prospective studies that a substantial number of medication-resistant patients with mania benefit from ECT (McCabe 1976; Black et al. 1986; Mukherjee et al. 1988). For example, one of the prospective studies required that patients had failed an adequate trial of lithium and/or an antipsychotic medication prior to randomization to ECT or intensive pharmacotherapy. Clinical outcome was superior with ECT compared to combined treatment with lithium and haloperidol (Mukherjee et al. 1989). Nonetheless, the evidence suggests that, as with major depression, medication resistance predicts poorer response to ECT in acute mania (Mukherjee et al. 1994). While the majority of medication-resistant patients with acute mania respond to ECT, the response rate is lower than among patients in whom ECT is used as a first-line treatment.

The rare syndrome of manic delirium represents a primary indication for the use of ECT, as it is rapidly effective with a high margin of safety (Constant 1972; Heshe and Roeder 1975; Kramp and Bolwig 1981). In addition, manic patients who cycle rapidly may be particularly unresponsive to medications, and ECT may represent an effective alternative treatment (Berman and Wolpert 1987; Mosolov and Moshchevitin 1990; Vanelle et al. 1994).

Other than medication resistance, there have been few attempts to examine clinical features predictive of ECT response in acute mania. One study suggested that symptoms of anger, irritability and suspiciousness were associated with poorer ECT outcome. Overall severity of mania and degree of depression (mixed state) at preECT baseline were not related to ECT response (Schnur et al. 1992). In this respect, there may be some overlap between the clinical features predictive of response to ECT and lithium in acute mania (Goodwin and Jamison 1990).

2.3.3. Schizophrenia. Convulsive therapy was introduced as a treatment for schizophrenia (Fink 1979). Early in its use, it became evident that efficacy of ECT was superior in mood disorders than in schizophrenia. The introduction of effective antipsychotic medications markedly reduced the utilization of ECT in patients with schizophrenia. However, ECT remains an important treatment modality, particularly for patients with schizophrenia who do not respond to pharmacological treatment (Fink and Sackeim 1996). In the United States, schizophrenia and related conditions (schizophreniform and schizoaffective disorders) constitute the second most common diagnostic indication for ECT (Thompson and Blaine 1987; Thompson et al. 1994).

The earliest reports on the efficacy of ECT in patients with schizophrenia largely comprised uncontrolled case series (Guttmann et al. 1939; Ross and Malzberg 1939; Zeifert 1941; Kalinowsky 1943; Kalinowsky and Worthing 1943; Danziger and Kindwall 1946; Kino and Thorpe 1946; Kennedy and Anchel 1948; Miller et al. 1953), historical comparisons (Ellison and Hamilton 1949; Gottlieb and Huston 1951; Currier et al. 1952; Bond 1954) and comparisons of ECT with milieu therapy or psychotherapy (Goldfarb and Kieve 1945; McKinnon 1948; Palmer et al. 1951; Wolff 1955; Rachlin et al. 1956). These early reports lacked operational criteria for diagnosis and it is likely that the samples included mood-disorder patients, given the overinclusiveness of the diagnosis of schizophrenia in that era (Kendell 1971; Pope and Lipinski, 1978). Often, patient samples and outcome criteria were poorly characterized. Nonetheless, the early reports were enthusiastic regarding the efficacy of ECT, noting that a large proportion of patients with schizophrenia, typically on the order of 75%, showed remission or marked improvement (see Salzman, 1980; Small, 1985; Krueger and Sackeim 1995 for reviews). In this early work, it was also noted that ECT was considerably less effective in schizophrenic patients with insidious onset and long duration of illness (Cheney and Drewry, 1938: Ross and Malzberg 1939; Zeifert 1941; Chafetz 1943; Kalinowsky 1943; Lowinger and Huddleson 1945; Danziger and Kindwall 1946; Shoor and Adams 1950; Herzberg 1954). It was also suggested that schizophrenic patients commonly required particularly long courses of ECT to achieve full benefit (Kalinowsky, 1943; Baker et al. 1960a).

Seven trials have used a ‘real vs. sham ECT’ design to examine efficacy in patients with schizophrenia (Miller et al. 1953; Ulett et al. 1954, 1956; Brill et al. 1957, 1959a, 1959b, 1959c; Heath et al. 1964; Taylor and Fleminger 1980; Brandon et al. 1985; Abraham and Kulhara 1987; see Krueger and Sackeim 1995 for a review). The studies prior to 1980 failed to demonstrate a therapeutic advantage of real ECT relative to sham treatment (Miller et al. 1953; Brill et al. 1959a, 1959b, 1959c; Health et al. 1964). In contrast, the three more recent studies all found a substantial advantage for real ECT in short-term therapeutic outcome (Taylor and Fleminger 1980; Brandon et al. 1985; Abraham and Kulhara 1987). The factors that likely account for this discrepancy are the chronicity of the patients studied and the use of concomitant antipsychotic medication (Krueger and Sackeim 1995). The early studies focused mainly on patients with a chronic, unremitting course, while patients with acute exacerbations were more common in recent studies. All of the recent studies involved use of antipsychotic medications in both the real ECT and sham groups. As discussed below, there is evidence that the combination of ECT and antipsychotic medication is more effective in schizophrenia than either treatment alone.

The utility of monotherapy with ECT or antipsychotic medication was compared in a variety of retrospective (DeWet 1957; Borowitz 1959; Ayres 1960; Rohde and Sargant 1961) and prospective (Baker et al. 1958, 1960b; Langsley et al. 1959; King 1960; Ray 1962; Childers 1964; May and Tuma 1965, May 1968; May et al. 1976,1981; Bagadia et al. 1970; Murrillo and Exner 1973a, 1973b; Exner and Murrillo 1973, 1977; Bagadia et al. 1983) studies of patients with schizophrenia. In general, short-term clinical outcome in schizophrenia with antipsychotic medication was found to be equivalent or superior to that of ECT, although there were exceptions.

(Murrillo and Exner 1973a). However, a consistent theme in this literature was the suggestion that patients with schizophrenia who had received ECT had superior long-term outcome compared with medication groups (Baker et al. 1958; Ayres 1960; May et al. 1976, 1981; Exner and Murrillo 1977). This research was conducted in an era when the importance of continuation and maintenance treatment was not appreciated and none of the studies controlled the treatment received following resolution of the schizophrenic episode. Nonetheless, the possibility that ECT may have long-term beneficial effects in schizophrenia merits attention.

A variety of prospective studies have compared the efficacy of combination treatment using ECT and antipsychotic medication with monotherapy with ECT or antipsychotic medication (Ray 1962; Childers 1964; Smith et al. 1967; Janakiramaiah et al. 1982; Small et al. 1982; Ungvari and Petho 1982; Abraham and Kulhara 1987; Das et al. 1991). Relatively few of these studies involved random assignment and blind outcome assessment. Nonetheless, in each of the three studies in which ECT alone was compared with ECT combined with an antipsychotic, medication there was evidence that the combination was more effective (Ray 1962; Childers 1964; Small et al. 1982). With the exception of Janakiramaiah et al (1982), all studies that compared the combination treatment with antipsychotic medication monotherapy found the combination treatment to be more effective (Ray 1962; Childers, 1964: Smith et al. 1967; Small et al. 1982: Ungvari and Petho 1982; Abraham and Kulhara 1987; Das et al. 1991). This pattern held despite the dosage of the antipsychotic medication often being lower when combined with ECT. The few findings on the persistence of benefit suggested that there was a reduced rate of relapse in patients who had received the combination of ECT and antipsychotic medication as acute phase treatment. A new study has also found that combination ECT and antipsychotic medication is more effective as a continuation therapy than either treatment alone in patients with medication-resistant schizophrenia who respond to the combination treatment in the acute phase (Chanpattana et al. in press). These results support the recommendation that in the treatment of patients with schizophrenia and possibly other psychotic conditions the combination of ECT and antipsychotic medication may be preferable to the use of ECT alone.

In current practice ECT is rarely used as a first-line treatment for patients with schizophrenia. Most commonly, ECT is considered in patients with schizophrenia only after unsuccessful treatment with antipsychotic medication. Thus, the key clinical issue concerns the efficacy of ECT in medication-resistant schizophrenic patients.

There has yet to be a prospective, blinded study in which patients with medication-resistant schizophrenia are randomized to continued treatment with antipsychotic medication or to ECT (either alone or in combination with antipsychotic medication). Information on this issue comes from naturalistic case series (Childers and Therrien 1961; Rahman 1968; Lewis 1982; Friedel 1986; Gujavarty et al, 1987; Konig and Glatter-Gotz 1990; Milstein et al. 1990; Sajatovi and Meltzer 1993; Chanpattana et al. in press). This work suggests that a substantial number of patients with medication-resistant schizophrenia benefit when treated with combination ECT and antipsychotic medication. The safe and effective use of ECT has been reported when it has been administered in combination with traditional antipsychotic medications (Friedel 1986; Gujavarty et al. 1987; Sajatovi and Meltzer 1993) or those with atypical properties, particularly clozapine (Masiar and Johns 1991; Klapheke 1991a. 1993; Landy 1991; Safferman and Munne 1992; Frankenburg et al. 1992; Cardwell and Nakai, 1995; Farah et al. 1995; Benatov et al. 1996). While some practitioners have been concerned that clozapine may increase the likelihood of prolonged or tardive seizures when combined with ECT (Bloch et al. 1996), such adverse events appear to be rare.

Prediction of response. Since the earliest research, the clinical feature most strongly associated with the therapeutic outcome of ECT in patients with schizophrenia has been the duration of illness. Patients with acute onset of symptoms (i.e., psychotic exacerbations) and shorter illness duration are more likely to benefit from ECT than patients with persistent, unremitting symptomatology (Cheney & Drewry 1938; Ross and Malzberg 1939; Zeifert 1941; Kalinowsky 1943; Lowinger and Huddelson 1945; Danziger and Kindwall 1946; Herzberg 1954; Landmark et al. 1987; Dodwell and Goldberg 1989). Less consistently, preoccupation with delusions and hallucinations (Landmark et al. 1987), fewer schizoid and paranoid premorbid personality traits (Wittman 1941; Dodwell and Goldberg 1989), and the presence of catatonic symptoms (Kalinowsky and Worthing 19431; Hamilton and Wall 1948; Ellison and Hamilton 1949; Wells, 1973; Pataki et al. 1992) have been linked to positive therapeutic effects. In general, the features that have been associated with the clinical outcome of ECT in patients with schizophrenia overlap substantially with features that predict outcome with pharmacotherapy (Leff and Wing 1971; World Health Organization 1979; Watt et al. 1983). While patients with unremitting, chronic schizophrenia are the least likely to respond, it has also been argued that such patients should not be denied a trial of ECT (Fink and Sackeim 1996). The probability of significant improvement with ECT may be low in such patients, but alternative therapeutic options may be even more limited, and a small minority of patients with chronic schizophrenia may show dramatic improvement following ECT.

ECT may also be considered in the treatment of patients with schizoaffective or schizophreniform disorder (Tsuang, et al. 1979; Pope et al. 1980; Ries et al. 1981; Black et al. 1987c). The presence of perplexity or confusion in patients with schizoaffective disorder may be predictive of positive clinical outcome (Perris 1974; Dempsy et al. 1975; Dodwell and Goldberg 1989). Many practitioners believe that the manifestation of affective symptoms in patients with schizophrenia is predictive of positive clinical outcome. However, the evidence supporting this view is inconsistent (Folstein et al. 1973; Wells 1973, Dodwell and Goldberg 1989).

2.4. Other Diagnostic Indications

ECT has been used successfully in some other conditions, although this utilization has been rare in recent years (American Psychiatric Association 1978, 1990, Thompson et al. 1994). Much of this usage has been reported as case material, and typically reflects the administration of ECT only after other treatment options have been exhausted or when the patient presents with life-threatening symptomatology. Because of the absence of controlled studies, which would, in any event, be difficult to carry out given the low utilization rates, any such referrals for ECT should be well substantiated in the clinical record. The use of psychiatric or medical consultation by individuals experienced in the management of the specific condition may be a useful component of the evaluation process.

2.4.1. Psychiatric disorders. Besides the major diagnostic indications discussed above, the evidence for the efficacy of ECT in the treatment of other psychiatric disorders is limited. As noted earlier, major diagnostic indications for ECT may coexist with other conditions, and practitioners should not be dissuaded by the presence of secondary diagnoses from recommending, ECT when it is otherwise indicated, e.g., a major depressive episode in a patient with a pre-existing anxiety disorder. However, there is no evidence of beneficial effects in patients with Axis II disorders or most other Axis I disorders who do not also have one of the major diagnostic indications for ECT. Although there are case reports of favorable outcome in some selective conditions, evidence for efficacy is limited. For example, some patients with medication-resistant obsessive compulsive disorder may show improvement with ECT (Gruber 1971; Dubois 1984; Mellman and Gorman 1984; Janike et al. 1987; Khanna et al. 1988; Maletzky et al. 1994). However, there have been no controlled studies in this disorder, and the longevity of the beneficial effect is uncertain.

2.4.2. Mental disorders due to medical conditions. Severe affective and psychotic conditions secondary to medical and neurological disorders, as well as certain types of deliria, may be responsive to ECT. The use of ECT in such conditions is rare and should be reserved for patients who are resistant or intolerant to more standard medical treatments, or who require an urgent response. Prior to ECT, attention should be given to the evaluation of the underlying etiology of the medical disorder. It is largely of historical interest that ECT has been reported to be of benefit in conditions such as alcoholic delirium (Dudley and Williams 1972; Kramp and Bolwig 1981), toxic delirium secondary to phencyclidine (PCP) (Rosen et al. 1984; Dinwiddie et al. 1988), and in mental syndromes due to enteric fevers (Breakey and Kala 1977; O’Toole and Dyck 1977; Hafeiz 1987), head injury (Kant et al. 1995), and other causes (Stromgren 1997). ECT has been effective in mental syndromes secondary to lupus erythematosus (Guze 1967; Allen and Pitts 1978; Douglas and Schwartz 1982; Mac and Pardo 1983). Catatonia may-be secondary to a variety of medical conditions and is usually responsive to ECT (Fricchione et al. 1990; Rummans and Bassingthwaighte 1991; Bush et al. 1996).

When evaluating potential secondary mental syndromes, it is important to recognize that cognitive impairment may be a manifestation of major depressive disorder. Indeed, many patients with major depression have cognitive deficits (Sackeim and Steif 1988). There is a subgroup of patients with severe cognitive impairment that resolves with treatment of the major depression. This condition has been termed “pseudodementia” (Caine, 1981). Occasionally, the cognitive impairment may be sufficiently severe to mask the presence of affective symptoms. When such patients have been treated with ECT, recovery has often been dramatic (Allen 1982; McAllister and Price 1982: Grunhaus et al. 1983: Burke et al. 1985: Bulbena and Berrios 1986; O’Shea et al. 1987; Fink 1989). It should be noted, however, that the presence of pre-existing neurological impairment or disorder increases the risks for ECT-induced delirium and for more severe and persistent amnestic effects (Figiel et al. 1990; Krystal and Coffey, 1997). Furthermore, among patients with major depression without known neurological disease, the extent of preECT cognitive impairment also appears to predict the severity of amnesia at follow-up. Thus, while patients with baseline impairment thought to be secondary to the depressive episode may show improved global cognitive function at follow-up, they may also be subject to greater retrograde amnesia (Sobin et al. 1995).

2.4.3. Medical disorders. The physiological effects associated with ECT may result in therapeutic benefit in certain medical disorders, independent of antidepressant, antimanic, and antipsychotic actions. Since effective alternative treatments are usually available for these medical disorders. ECT should be reserved for use on a secondary basis.

There is now considerable experience in the use of ECT in patient’s with Parkinson’s disease (see Rasmussen and Abrams 1991; Kellner et al. 1994 for reviews). Independent of effects on psychiatric symptoms, ECT commonly results in general improvement in motor function (Lebensohn and Jenkins 1975; Dysken et al. 1976; Ananth et al. 1979; Atre-Vaidya and Jampala 1988; Roth et al. 1988; Stem 1991; Jeanneau, 1993; Pridmore and Pollard 1996). Patients with the “on-off” phenomenon, in particular, may show considerable improvement (Balldin et al. 1980 198 1; Ward et al. 1980; Andersen et al. 1987). However, the beneficial effects of ECT on the motor symptoms of Parkinson’s disease are highly variable in duration. Particularly in patients who are resistant or intolerant to standard pharmacotherapy, there is preliminary evidence that continuation or maintenance ECT may be helpful in prolonging the therapeutic effects (Pridmore and Pollard 1996).

Neuroleptic malignant syndrome (NMS) is a medical condition that has been repeatedly shown to improve following ECT (Pearlman 1986; Hermle and Oepen 1986; Pope et al. 1986-1 Kellam 1987; Addonizio and Susman 1987; Casey 1987; Hermesh et al. 1987; Weiner and Coffey 1987; Davis et al. 1991). ECT is usually considered in such patients after autonomic stability has been achieved, and should not be used without discontinuation of neuroleptic medications. Since the presentation of NMS restricts the pharmacological options for treatment of the psychiatric condition, ECT may have the advantage of being effective for both the manifestations of NMS and the psychiatric disorder.

ECT has marked anticonvulsant properties (Sackeim et al. 1983; Post et al. 1986) and its use as an anticonvulsant in patients with seizure disorders has been reported since the 1940s (Kalinowsky and Kennedy 1943; Caplan 1945, 1946; Sackeim et al. 1983; Schnur et al. 1989). ECT may be of value in patients with intractable epilepsy or status epilepticus unresponsive to pharmacological treatment (Dubovsky 1986; Hsiao et al. 1987; Griesener et al. 1997; Krystal and Coffey 1997).

RECOMMENDATIONS

2.1. General Statement

Referrals for ECT are based upon a combination of factors, including, the patient’s diagnosis, type and severity of symptoms, treatment history, consideration of the anticipated risks and benefits of ECT and alternative treatment options, and patient preference. There are no diagnoses which should automatically lead to treatment with ECT. In most cases ECT is used following treatment failure on psychotropic medications (see Section 2.2.2), although specific criteria exist for the use of ECT as a first-line treatment (see Section 2.2.1).

2.2. When Should a Referral for ECT Be Made?

2.2.1. Primary Use of ECT

Situations where ECT may be used prior to a trial of psychotropic medication include, but are not limited to, any of the following:

a) need for rapid, definitive response due to the severity of a psychiatric or medical condition

b) the risks of other treatments outweigh the risks of ECT

c) history of poor medication response or good ECT response in one or more previous episodes of illness

d) patient preference

2.2.2. Secondary Use of ECT

In other situations, a trial of an alternative therapy should be considered prior to referral for ECT. Subsequent referral for ECT should be based on at least one of the following:

a) treatment resistance (taking into account issues such as choice of medication, dosage and duration of trial, and compliance)

b) intolerance or adverse effects with pharmacotherapy which are deemed less likely or less severe with ECT

c) deterioration of the patient’s psychiatric or medical condition creating a need for a rapid, definitive response

2.3. Major Diagnostic Indications

Diagnoses for which either compelling data support the efficacy of ECT or a strong consensus exists in the field supporting such use:

2.3.1. Major Depression

a) ECT is an effective treatment for all subtypes of unipolar major depression, including major depression single episode (296.2x) and major depression, recurrent (296.3x) (American Psychiatric Association 1994).

b) ECT is an effective treatment for all subtypes of bipolar major depression, including bipolar disorder; depressed (296.5x); bipolar disorder mixed (296.6x); and bipolar disorder not otherwise specified (296.70).

2.3.2. Mania

ECT is an effective treatment for all subtypes of mania, including bipolar disorder, mania (296.4x); bipolar disorder, mixed (296.6x), and bipolar disorder, not otherwise specified (296.70).

2.3.3. Schizophrenia and Related Disorders

a) ECT is an effective treatment for psychotic exacerbations in patients with schizophrenia in any of the following situations:

1) when duration of illness from initial onset is short

2) when psychotic symptoms in the present episode have an abrupt or recent onset

3) catatonia (295.2x) or

4) when there is a history of a favorable response to ECT

b) ECT is effective in related psychotic disorders, notably schizophreniform disorder (295.40) and schizoaffective disorder (295.70). ECT may also be useful in patients with psychotic disorders not otherwise specified (298-90) when the clinical features are similar to those of other major diagnostic indications.

2.4. Other Diagnostic Indications

There are other diagnoses for which the efficacy data for ECT are only suggestive or where only- a partial consensus exists in the field supporting its use. In such cases, ECT should be recommended only after standard treatment alternatives have been considered as a primary intervention. The existence of such disorders, however, should not deter the use of ECT for treatment of patients who also have a concurrent major diagnostic indication.

2.4.1. Psychiatric Disorders

Although ECT has sometimes been of assistance in the treatment of psychiatric disorders other than those described above (Major Diagnostic Indications, Section 2.3), such use is not adequately substantiated and should be carefully justified in the clinical record on a case-by-case basis.

2.4.2. Psychiatric Disorders Due to Medical Conditions

ECT may be effective in the management of severe secondary affective and psychotic conditions displaying symptomatology similar to primary psychiatric diagnoses, including catatonic states.

There is some evidence that ECT may be effective in treating deliria of various etiologies, including toxic and metabolic.

2.4.3. Medical Disorders

The neurobiological effects of ECT may be of benefit in a small number of medical disorders.

Such conditions include:

a) Parkinson’s disease (particularly with the “on-off ‘ phenomenon b) neuroleptic malignant syndrome

c) intractable seizure disorder

Chapter 3. Medical Conditions Associated with Substantial Risk

ECT is often administered to patients with severe medical illness (see Chapter 4.1). In fact, it commonly is the treatment of choice in medically ill patients because of its speed of action and safety profile. There are no absolute medical contraindications to ECT. Instead, it is more pertinent to think in terms of degree of risk relative to the potential benefits of ECT.

Some conditions substantially increase the risk of treatment. For each patient, the attending physician and treating psychiatrist must undertake a risk-benefit analysis, including consideration of the seventy and duration of the illness and its threat to life; the likelihood of therapeutic success with ECT; the medical risks of ECT; and the benefits and risks of alternative treatments and of no treatment. After such an analysis, a choice can be made regarding the optimal intervention for an individual patient. In treating “high risk” patients with ECT, attempts should be made to improve and stabilize risk-related medical conditions (see Chapter 4.1). Careful medical evaluation is an essential component of this process and may include consultations with internists, cardiologists, neurologists, and other specialists (see Chapter 6).

The two organ systems of most importance when considering the medical risks of ECT are the cardiovascular system and the central nervous system. Most of the medical complications and mortality associated with ECT are referable to the heart. Recent myocardial infarction is believed to represent a risk for re-infarction during ECT (Applegate 1997). The concept of “recency” as it applies to this condition is difficult to define in the absence of relevant supporting data. The risks at six weeks following a mild myocardial infarction without adverse sequelae may be less than those present at six months following a severe, complicated infarction. In many cases of pre-existing cardiac disease the risks of ECT may be reduced by the use of short-acting intravenous antihypertensive agents (McCall et at. 1991) that diminish the hemodynamic changes that occur during the treatment or that exert other cardioprotective effects (set Chapter. 4.1).

Although there are little data to tie other specific cardiac disorders to substantially elevated morbidity and mortality with ECT, perioperative risk in general is believed to be greatly elevated in the presence of either uncompensated congestive heart failure or severe valvular heart disease (Dovinsky and Zyara 1997; Rayburn 1997). Again, pharmacologic means to diminish such risk exists (see Chapter 4.1). A similar situation can be said to exist with respect to vascular aneurysms. Here, lesions that are at increased risk of rupture with transient elevations in blood pressure are of particular concern, although, once more, data are lacking and the degree of risk can once more be minimized by appropriate acute antihypertensive prophylaxis (see Chapter 4.1).

Regarding the central nervous system, conditions associated with increased intracranial pressure, such as some brain tumors, are theoretically of great concern (Krystal and Coffey 1997). In the presence of these conditions, the rise in intracranial pressure that occurs with ECT could lead to brain herniation. However, such events are rare in practice (Kellner 1996). Most of the reports of dire outcomes are from the distant past when ECT technique was far less sophisticated (Maltbie 1980). The type and size of brain tumor also correlate with the degree of danger, smaller and slow-growing neoplasms posing less risk. For example, there are now several case reports of successful ECT in the presence of meningiomas (Fried and Mann 1988,- Greenberg et al. 1988: Hsiao 1984: Kellner and Rames, 1990; Malek-Ahmadi and Sedler 1989; Zwil et al. 1990). Clearly, clinical judgement needs to be exercised in determining the risk-benefit ratio in each individual case. Only rarely would one treat a patient with a known, large brain tumor, and likewise, only rarely would one need to avoid ECT in a patient with a small, stable meningioma. There is little information about the safety of ECT in other conditions associated with increased intracranial pressure, such as hydrocephalus or normal pressure hydrocephalus.

ECT may pose additional risks in patients who have recently suffered a cerebral infarct. Reports of stroke (either hemorrhagic or ischemic) during or shortly after ECT are surprisingly rare. Given the magnitude of hemodynamic changes, that occur during the treatment and the number of patients with cerebrovascular disease who receive ECT (Miller and Isenberg 1998; Zwil et al. 1992). This finding may be due to the brief duration of blood pressure and heart rate changes that are associated with ECT. Maintenance of blood pressure within a fairly narrow range is generally thought to be prudent, in order to avoid the potential risk of cerebral bleeding with severe hypertension or cerebral ischemia with hypotension (see Chapter 4.1).

Severe pulmonary conditions may lead to difficulties in airway management during and after the procedure. Consultation with anesthesiology or other staff regarding management (e.g. pre-ECT use of bronchodilators, attention to pre-treatment oxygenation) will often be indicated.

Patients with severe cardiopulmonary or other organ system disease that renders them high anesthesia risks (ASA level 4 or 5) also represents potentially high risk situations with ECT. Specialty consultations before ECT are often indicated to optimize the patient’s medical status (see Chapter 4.1 ).

In addition to medical conditions that increase the risks of ECT, certain medication regimens may also contribute to risk (see, Chapter 7).

RECOMMENDATIONS

1) There are no “absolute” medical contraindications to ECT.

2) Situations exist in which ECT is associated with an increased likelihood of serious morbidity or mortality. For such patients, the decision to administer ECT should be based upon the premise that their psychiatric condition is grave and that ECT is the safest treatment available.

3) Careful medical evaluation of risk factors should be carried out prior to ECT, with specific attention to modifications of the patient’s management and the administration of ECT which may diminish the level of risk (see Section 4.1).

4) Specific conditions that may be associated with substantially increased risk include the following:

a) unstable or severe cardiovascular conditions such as recent myocardial infarction, poorly compensated congestive heart failure, and severe valvular cardiac disease.

b) aneurysm or vascular malformation that might be susceptible to rupture with increased blood pressure.

c) increased intracranial pressure, as may occur with some brain tumors or other space-occupying cerebral lesions.

d) recent cerebral infarction.

e) pulmonary conditions such as severe chronic obstructive pulmonary disease, asthma, or pneumonia.

f) anesthetic risk rated as ASA level 4 or 5.

Chapter 5. Adverse Effects

5.1. Medical Complications

Precise rates of mortality attributable to ECT are difficult to determine due to methodological issues intrinsic to studies of medical mortality, such as uncertainty as to cause of death, time frame for linking death to ECT, and variability in reporting requirements. The mortality attributed to ECT is estimated to be approximately the same as that associated with minor surgery (McCabe 1985 Warner et al. 1993; Brand et al. 1994; Badrinath et al. 1995: Hall et al. 1997). Published estimates from large and diverse patient series over several decades report up to 4 deaths per 100,000 treatments (Heshe and Roeder, 1976; Fink, 1979; Weiner 1979; Babigian and Guttmacher, 1984; Crowe, 1984; Kramer, 1985: Abrams 1997b; Reid et al. 1998). Despite the frequent use of ECT in patients with significant medical complications and in the elderly (Sackeim 1993, 1998; Weiner et al. in press), rates of mortality appear to have decreased in recent years. A reasonable current estimate is that the rate of ECT-related mortality is 1 per 10,000 patients. This rate may be higher in patients with severe medical conditions. The rate of significant morbidity and mortality is believed to be lower with ECT than with treatment with some types of antidepressant medication (e.g., tricyclics) (Sackeim 1998). There is also evidence from longitudinal follow-up studies that mortality rates following hospitalization are lower among depressed patients who received ECT than patients who received alternative forms of treatment or no treatment (Avery and Winokur, 1976; Philibert et al. 1995)

When mortality occurs with ECT, it typically happens immediately following the seizure or during the postictal recovery period. Cardiovascular complications are the leading cause of death and of significant morbidity (Pitts 1982; Burke et al. 1987; Welch and Drop 1989; Zielinski et al. 1993; Rice et al. 1994). Despite the short-lived increases in cerebral blood flow and intracranial pressure, cerebrovascular complications are notably rare (Hsiao et al. 1987). Given the high rate of cardiac arrhythmias in the immediate postictal period, the majority of which are benign and resolve spontaneously, ECG should be monitored during and immediately following the procedure (see Section 11.8) and patients should not be taken to the recovery area until there is resolution of significant arrhythmias. Vital signs (pulse, systolic and diastolic pressure) should be stable prior to the patient’s leaving the recovery area (Section 11.10). Patients with pre-existing cardiac illness are at greater risk for post-ECT cardiac complications (Prudic et al. 1987; Zielinski et al. 1993; Rice et al. 1994). Indeed, there is evidence that the type of pre-existing cardiac disease predicts the type of complication that may be encountered following ECT. For example, ventricular arrythmias are more common in patients with pre-existing ventricular abnormalities than in patients with ischemic heart disease (Zielinski et al. 1993). Management of cardiac complications is discussed in Chapter 11.

Two other possible sources of morbidity are prolonged seizures and tardive seizures (Weiner et al. 1980a). Management of prolonged seizures is described in Section 11.9. Failure to terminate seizures within a period of 3 to 5 minutes may increase postictal confusion and amnesia. Inadequate oxygenation during prolonged seizures increases the risk of hypoxia and cerebral dysfunction, as well as cardiovascular complications. In animal studies, seizure activity that is sustained for periods exceeding 30-60 minutes, regardless of steps taken to maintain appropriate levels of blood gases, is associated with an increased risk of structural brain damage and cardiovascular and cardiopulmonary complications (Meldrum et al. 1974; Ingvar 1986; Meldrum 1986; Siesjo et al. 1986; O’Connell et al. 1988; Devanand et al. 1994).

Prolonged seizures and status epilepticus may be more likely in patients receiving medications that lower seizure threshold or interfere with seizure termination (e.g. theophylline, even at therapeutic levels) (Peters et al. 1984; Devanand et al. 1988a; Abrams, 1997a), in patients receiving concomitant lithium therapy (Weiner et al. 1980b), in patients with pre-existing electrolyte imbalance (Finlayson et al. 1989), and with the repeated induction of seizures within the same treatment session (e.g., multiple monitored ECT) (Strain-and Bidder 1971, Maletzky 1981).

There has been concern as to whether the rate of spontaneous seizures is increased following the course of ECT (Assael et al. 1967; Devinsky and Duchowny 1983). The evidence indicates, however, that such events are extremely rare and probably do not differ from population base rates (Blackwood et al. 1980; Small et al. 1981). There are no data concerning rates of tardive seizures, i.e., seizures that occur following termination of the ECT-induced seizure, but experience indicates that these are also rare events. As noted in Section 11.9, prolonged or tardive seizures occurring during the immediate postictal period are often not accompanied by motor manifestations, underscoring the need for EEG seizure monitoring (Rao et al. 1993). Nonconvulsive status epilepticus may also occur in the interictal period, with an abrupt onset of delirium, unresponsiveness, and/or agitation as distinguishing clinical features (Grogan et al. 1995). Cessation of EEG abnormalities and improved cognitive function following short-acting anticonvulsant treatment (e.g. intravenous lorazepam or diazepam) may prove diagnostic (Weiner and Krystal, 1993).

Prolonged postictal apnea is a rare event that occurs primarily in patients with a pseudocholinesterase deficiency resulting in slow metabolism of succinylcholine (Packman et al. 1978). Maintaining adequate oxygenation is critical in instances of prolonged apnea, which will usually resolve spontaneously within 30 to 60 minutes. When prolonged apnea is encountered, it is helpful to obtain a dibuciane number assay or a pseudocholinesterase level prior to the next treatment in order to establish etiology. At subsequent treatments, either a very low dose of succinylcholine may be used or a non-depolarizing muscle relaxant, such as atracurium, may be substituted (Hickey et al. 1987; Hicks, 1987; Stack et al. 1988; Kramer and Afrasiabi 1991; Lui et al. 1993).

To some extent, medical adverse events can be anticipated. Whenever possible, the risks of such events should be minimized by optimization of the patient’s medical condition prior to ECT and/or modifications in ECT procedures. Patients with preexisting cardiac illness, compromised pulmonary status, a history of CNS insult, or medical complications following prior courses of anesthesia or ECT are especially likely to be at increased risk (Weiner and Coffey 1988; Zieliniski et al. 1993). ECT psychiatrists should review the medical work-up and history of prospective ECT patients (see Chapter 6). Specialist consultations or additional laboratory studies may be called for, as well as changes in medication regimens. In spite of careful pre-ECT evaluation, medical complications may arise which have not been anticipated. ECT facilities should be staffed with personnel prepared to manage potential clinical emergencies and should be equipped accordingly (see Chapters 9 and 10). Examples of these events include cardiovascular complications (such as cardiac arrest, arrythmias, ischemia, hyper- and hypotension), prolonged apnea, and prolonged or tardive seizures and status epilepticus.

Major adverse events that occur during or soon after the ECT course should be documented in the patient’s medical record. The steps taken to manage the event, including specialist consultation, use of additional procedures, and administration of medications, should likewise be documented. As cardiovascular complications are the most likely source of significant adverse events and are seen most frequently in the immediate post-ECT period, the treatment team should be capable of managing the major classes of cardiovascular complications. A set of predetermined procedures for dealing with instances of prolonged or tardive seizures and status epilepticus are helpful.

5.2. Systemic Side Effects

Headache is a common side effect of ECT and is observed in as many as 45% of patients during and shortly following the postictal recovery period (Devanand et al. 1995; Freeman and Kendell 1980; Gomez 1975; Sackeim et al. 1987d: Tubi et al. 1993; Weiner et al. 1994). However, the precise incidence of postECT headache is difficult to determine due to methodological issues such as the high baseline (preECT) occurrence of headache in patients with depression, the potential effects of concurrent medication or medication withdrawal, and differences between studies in the assessment of headache. PostECT headache appears to be particularly common in younger patients (Devanand et al. 1995) and especially in children and adolescents (Rey and Walter 1997; Walter and Rey 1997) It is not known whether pre-existing headache syndromes (e.g., migraine) increase the risk of postECT headache, but ECT may exacerbate a previous headache condition (Weiner et al. 1994). The occurrence of postECT headache does not appear to be related to stimulus electrode placement (at least bifrontotemporal vs. right unilateral) (Fleminger et al. 1970; Sackeim et al. 1987d; Tubi et al. 1993; Devanand et al. 1995), stimulus dosage (Devanand et al. 1995), or therapeutic response to ECT (Sackeim et al. 1987d; Devanand et al. 1995).

In most patients the postECT headache is mild (Freeman and Kendell 1980; Sackeim et al. 1987d), although a sizable minority will report severe pain associated with nausea and vomiting. Typically the headache is frontal in location and has a throbbing character.

The etiology of postECT headache is not known. Its throbbing character suggests a similarity with vascular headache, and ECT may be associated with a temporary change in quality of headache from muscle-contraction type to vascular type (Weiner et al. 1994; Weinstein 1993). Indeed, ECT upregulates 5-HT2 receptors and 5-HT2 receptor sensitization has been associated with development of vascular headache (Weiner et al. 1994). Other suggested mechanisms include electrically induced temporalis muscle spasm or acute increase in blood pressure and cerebral blood flow (Abrams 1997a; Weiner et al. 1994).

Treatment of postECT headache is symptomatic. Aspirin, acetaminophen, or non-steroidal anti-inflammatory drugs (NSAIDs) typically are highly effective, particularly if given promptly after the onset of pain. Sumatriptan, a serotonin 5HTID receptor agonist, has also been effective at doses of 6 mg subcutaneously (DeBattista and Mueller 1995) or 25 – 100 mg orally (Fantz et al. in press). Some patients will require more potent analgesics (e.g. codeine), although narcotics may contribute to associated nausea. Most patients also benefit from bed rest in a quiet, darkened environment.

PostECT headache may occur after any ECT treatment in a course, irrespective of its occurrence at any prior treatment. Patients who experience frequent postECT headache may benefit from prophylactic treatment, such as aspirin, acetaminophen, or NSAIDs given as soon as possible after ECT, or even immediately prior to the ECT treatment. Subcutaneous sumatriptan 6 mg given several minutes prior to ECT was also found to provide effective prophylaxis in a patient with severe, refractory postECT headache (DeBattista and Mueller 1995).

Estimates of the prevalence of nausea following ECT vary from 1.4% – 23% of patients (Gomez 1975; Sackeim et al. 1987d), but the occurrence is difficult to quantify because of methodological issues noted above for headache. Nausea may occur secondary to headache or its treatment with narcotics, particularly in patients with vascular-type headache. It may also occur independently either as a side effect of anesthesia or via other unknown mechanisms. When nausea accompanies headache, the primary treatment should focus on the relief of headache as outlined above. PostECT nausea is otherwise typically well controlled with dopamine-blocking agents, such as phenothiazine derivatives (e.g. prochlorperazine and others), butyrophenones (haloperidol, droperidol), trimethabenzamide, or metoclopramide. If nausea is severe or accompanied by vomiting these agents should be administered parenterally or by suppository. All of these agents have the potential to cause hypotension and motoric side effects, and may lower seizure threshold. If nausea does not respond to these treatments or if side effects are problematic, the serotonin 5HT3 receptor antagonists ondansetron or dolasetron may be useful alternatives. These medications may be given in single intravenous doses of 4 mg and 12.5 mg respectively, several minutes before or after ECT. The greater expense of these medications and their lack of proven superiority over traditional anti-emetics in the setting, of ECT may limit their routine use. If problematic nausea routinely follows the use of a particular anesthetic, an alternative anesthetic may be considered.

5.3 ). Treatment Emergent Mania

As with pharmacological antidepressant treatments, a small minority of depressed patients or patients in mixed affective states switch into hypomania or mania during the ECT course (Devanand et al. 1988b; Andrade et al. 1988b, 1990; Angst et al. 1992; Devanand et al. 1992). In some patients, the severity of manic symptoms may worsen with further ECT treatments. In such cases, it is important to distinguish treatment emergent manic symptoms from delirium with euphoria (Devanand et al. 1988b). There are a number of phenomenological similarities between the two conditions. However, in delirium with euphoria patients are typically confused and have pronounced memory disturbance. The confusion or disorientation should be continuously present and evident from the period immediately following the treatment. In contrast, hypomanic or manic symptomatology may occur in the context of a clear sensorium. Therefore, evaluating cognitive status may be particularly helpful in distinguishing between these states. In addition, states of delirium with euphoric are often characterized by a giddiness in mood or “carefree” disposition. Classical features of hypomania, such as racing thoughts, hypersexuality, irritability, etc. may be absent. In cases of delirium with euphoria an increase in the time between treatments, a decrease in the stimulus intensity, or a change to unilateral from bilateral electrode placement may lead to resolution of the condition.

There is no established strategy on how to manage emergent manic symptoms during the ECT course. Some practitioners continue ECT to treat both the mania and any residual depressive symptomatology. Other practitioners postpone further ECT and observe the patient’s course. At times, manic symptomatology will remit spontaneously without further intervention. Should the mania persist, or the patient relapse back into depression, reinstitution of ECT may be considered. Yet other practitioners terminate the ECT course and start pharmacotherapy, often with lithium carbonate or other mood stabilizer, to treat emergent manic symptomatology.

5.4. Objective Cognitive Side Effects

The cognitive side effects produced by ECT have been the subject of intense investigation (Squire 1986; Sackeim 1992; McElhiney et al. 1995) and are the major complications limiting its use. ECT psychiatrists should be familiar with the nature and variability of cognitive side effects, and this information should be conveyed during the consent process (see Chapter 8 ).

The cognitive side effects of ECT have four essential features. First, the nature and severity of cognitive alterations rapidly change with time from last treatment. The most severe cognitive side effects are observed in the postictal period. Immediately following seizure induction, patients experience a variable, but usually brief, period of disorientation, with impairments in attention, praxis, and memory (Sackeim 1986). These deficits recede at variable rates over time. Consequently, the magnitude of deficits observed during the course of ECT will be a function, in part, of the time of assessment relative to the last treatment and the number of treatments received (Daniel and Crovitz, 1983a; Squire et al. 1985).

Second, the methods used in ECT administration profoundly impact on the nature and magnitude of cognitive deficits. For example, the methods of ECT administration will strongly determine the percentage of patients that develop delirium, characterized by continuous disorientation (Miller et al. 1986; Daniel and Crovitz 1986; Sackeim et al. 1986, 1993). In general, as described in Table 1, bilateral electrode placement, sine wave stimulation, high electrical dosage relative to seizure threshold, closely spaced treatments, larger numbers of treatments, and high dosage of barbiturate anesthetic agents are each independently associated with more intense cognitive side effects compared to right unilateral electrode placement, brief pulse waveform, lower electrical intensity, more widely spaced treatments, fewer treatments, and lower dosage of barbiturate anesthesia (Miller et al. 1985; Sackeim et al. 1986; Weiner et al. 1986b: Sackeim et al. 1993; Lerer et al. 1995; McElhiney et al. 1995). Optimization of these parameters can minimize short-term cognitive side effects and likely reduce the magnitude of long-term changes (Sobin et al. 1995). In patients who develop severe cognitive side effects, such as delirium (Summers et al. 1979; Miller et al. 1986; Mulsant et al. 1991), the attending physician and ECT psychiatrist should review and adjust the treatment technique being used, such as switching to unilateral ECT, lowering the electrical dosage administered, and/or increasing the time interval between treatments, and decrease the dosage or discontinue any medications being administered that may exacerbate cognitive side effects.

Third, patients vary considerably in the extent and severity of cognitive side effects following ECT. There is limited information about the factors that contribute to these individual differences. There is evidence that among depressed patients without known neurological disease or insult, the extent of preECT global cognitive impairment, i.e., mini-Mental State Exam (MMSE) scores, predicts the magnitude of retrograde amnesia for autobiographical information at long-term follow-up. While ECT typically results in improvement in global cognitive status in these patients, as a function of symptomatic response, nonetheless, these same patients may have greater persistent amnesia for personal memories (Sobin et al. 1995). Similarly, there is evidence that the duration of disorientation immediately following the ECT treatment is independently predictive of the magnitude of retrograde amnesia for autobiographical information. Patients who require prolonged periods to recover orientation may be at greater risk for more profound and persistent retrograde amnesia (Sobin et al. 1995). Patients with pre-existing neurological disease or insult (e.g., Parkinson’s disease, stroke) may also be at increased risk for ECT-induced delirium and memory deficits (Figiel et al. 1991). Magnetic resonance imaging (MRI) findings of basal ganglia lesions and severe white matter hyperintensities have also been linked to the development of an ECT-induced delirium (Figiel et al. 1990). Some medications may exacerbate ECT-induced cognitive side effects. These include lithium carbonate (Small et al. 1980; Weiner et al. 1980b), and medications with marked anticholinergic, properties, particularly in elderly patients.

Fourth, ECT results in highly characteristic cognitive changes. Across diagnostic groups, prior to receiving ECT, many patients have deficits in attention and concentration that limit their capacity information (Byrne 1977; Pogue-Geile and Oltmanns, 1980; Cornblatt et al. 1981; Sackeim and Steif, 1988). For example, patients with severe psychopathology often have deficient recall of information that was just presented to them (immediate memory). In depressed patients, these deficits are most marked for unstructured material that requires effortful processing in order to impose organization (Weingartner and Silberman 1984; Roy-Byrne et al. 1986). However, such patients are considerably less likely to have deficits in retaining the new information that they do learn (delayed memory) (Cronholm and Ottosson 1961; Sternberg and Jarvik 1976; Steif et al. 1986). With symptomatic response following ECT, the deficits in attention and concentration usually resolve. Consequently, measures of immediate memory are either unchanged or improved within a few days of ECT termination (Cronholm and Ottosson, 1961; Steif et al. 1986; Weiner et al. 1986b; Rossi et al. 1990; Sackeim et al. 1993). Since attention and concentration are essential to many aspects of cognitive function, it is not surprising that shortly following completion of the ECT course improvement may be observed in a wide variety of neuropsychological domains, including global cognitive status (Sackeim et al. 1991; Sobin et al. 1995) and measures of general intelligence (IQ) (Huston and Strother 1948; Stieper et al 1951; Squire et al. 1975; Malloy et al. 1981; Sackeim et al. 1992). There is no evidence that ECT results in impairments of executive functions (e.g., the capacity to shift mental sets), abstract reasoning, creativity, semantic memory, implicit memory, or skill acquisition or retention (Weeks et al. 1980; Frith et al. 1983; Squire et al. 1984; Taylor and Abrams 1985; Jones et al. 1988).

Against this background of unchanged or improved neuropsychological performance, ECT selectively results in anterograde and retrograde amnesia. The anterograde amnesia is characterized by rapid forgetting of newly-learned information (Cronholm and Ottosson 1961; Squire 1986; Steif et al. 1986; Weiner et al. 1986b; Frith et al. 1987; Sackeim et al. 1993). As noted, compared to preECT baseline, a few days following ECT patients may recall more items in a list that was just presented. However, recall after a delay will often be impaired (Korin et al. 1956; Cronholm and Ottosson 1961; Cronholm and Molander 1964; Squire and Miller 1974; Steif et al. 1986; Weiner et al. Squire and Chace 1975; d’Elia 1976; Robertson and Inglis 1978, 1986b; Calev et al. 1989b; Sackeim et al. 1993). The extent and persistence of this rapid forgetting of newly learned information varies among patients and should be taken into account when making recommendations regarding the postECT convalescence period. Until there is substantial resolution of the anterograde amnesia, returning to work, making important financial or personal decisions, or driving may be restricted. The anterograde amnesia rapidly resolves following the termination of ECT. Indeed, no study has documented anterograde amnestic effects of ECT more than a few weeks following the ECT course (Strain et al. 1968; Bidder et al. 1970; Heshe et al. 1978; Jackson, 1978; Fraser and Glass, 1980; Weeks et al. 1980; Gangadhar et al. 1982; Frith et al. 1983; Weiner et al. 1986b; Sackeim et al. 1993). It is unlikely that ECT has any long-term effect on the capacity to learn and retain new information.

Following ECT, patients also display retrograde amnesia. Deficits in the recall of both personal (autobiographical) and public information are usually evident, and the deficits are typically greatest for events that occurred temporally closest to the treatment (Janis, 1950; Cronholm and Molander 1961; Strain et al. 1968; Squire 1975; Squire et al. 1975, 1976, 1981; Weeks et al. 1980; Sackeim et al. 1986; Wiener et al 1986b; Sackeim et al 1993; McElhiney et al. 1995). The magnitude of the retrograde amnesia is greatest immediately following the treatment. A few days following the ECT course, memory for events in the remote past is usually intact, but there may be difficulty in recalling events that transpired several months to years prior to ECT. The retrograde amnesia over this time span is rarely complete. Rather, patients have gaps or spottiness in their memories of personal and public events. Recent evidence suggests that the retrograde amnesia is typically greater for public information (knowledge of events in the world) as compared to personal information (autobiographic details of the patient’s life) (Lisanby et al. in press). The emotional valence of autobiographical events, i.e., memories of pleasant or distressful events, is not related to their likelihood of being forgotten (McElhiney et al. 1995).

As time from ECT increases, there is usually substantial reduction in the extent of retrograde amnesia. Older memories are more likely to be recovered. The time course for this shrinkage of retrograde amnesia is often more gradual than that for the resolution of anterograde amnesia. In many patients the recovery from retrograde amnesia will be incomplete, and there is evidence that ECT can result in persistent or permanent memory loss (Squire et al. 1981; Weiner et al. 1986b; McElhiney et al. 1995; Sobin et al. 1995). Owing to a combination of anterograde and retrograde effects, many patients may manifest persistent loss of memory for some events that transpired in the interval starting several months before and extending to several weeks following the ECT course. There are individual differences, however, and, uncommonly, some patients may experience persistent amnesia that extends back several years prior to ECT. Profound and persistent retrograde amnesia may be more likely in patients with pre-existing neurological impairment and patients who receive large numbers of treatments, using methods that accentuate acute cognitive side effects (e.g., sine wave stimulation, bilateral electrode placement, high electrical stimulus intensity).

To determine the occurrence and severity of cognitive changes during and following the ECT course, orientation and memory functions should be assessed prior to initiation of ECT and throughout the course of treatment (see Chapter 12 for details).

5.5. Adverse Subjective Reactions

Negative subjective reactions to the experience of receiving ECT should be considered adverse side effects (Sackeim 1992). Prior to ECT, patients often report apprehension; rarely, some patients develop intense fear of the procedure during the ECT course (Fox 1993). Family members are also frequently apprehensive about the effects of the treatment. As part of the consent process prior to the start of ECT, patients and family members should be given the opportunity to express their concerns and questions to the attending physician and/or members of the ECT treatment team (see Chapter 8 ). Since much of the apprehension may be based on lack of information, it is often helpful to provide patients and family members with an information sheet describing basic facts about ECT (see Chapter 8 ). This material should be supplemental to the consent form. It is also useful to make available video material on ECT. Addressing the concerns and educational needs of patients and family members should be a process that continues throughout the course. In centers that regularly conduct ECT, it has been found useful to have ongoing group sessions led by a member of the treatment team, for patients receiving ECT and/or their significant others. Such group sessions, including prospective and recently treated patients and their families, may engender mutual support among these individuals and can serve as a forum for education about ECT.

Shortly following ECT, the great majority of patients report that their cognitive function is improved relative to their pre-ECT baseline (Cronholm and Ottosson 1963b; Shellenberger et al 1982; Frith et al 1983; Pettinati and Rosenberg 1984; Weiner et al 1986b; Mattes et al 1990; Calev et al 1991; Sackeim et al. 1993 ); Coleman et al 1996). Indeed, recent research has shown that two months following completion of ECT the memory self-ratings of former patients are markedly improved relative to their pre-ECT baseline and indistinguishable from healthy controls (Coleman et al. 1996). In patients who have received ECT, memory self-ratings show little association with the results of objective neuropsychological testing (Cronholm and Ottosson 1963b; Frith et al 1983; Squire and Slater 1983; Weiner et al 1986b; Squire and Zouzounis 1988; Calev et al 1991a; Coleman et al 1996). Likewise, in healthy and neurological samples, subjective memory assessments have generally shown weak or no association with objective neuropsychological measures (Bennett-Levy and Powell 1980; Broadbent et al. 1982; Rabbitt 1982; Larrabee and Levin 1986; Sackeim and Stem 1997). In contrast, strong associations are observed between mood state and memory self-ratings among patients who have received ECT, as well as other populations (Stieper et al. 1951; Frith et al 1983; Pettinati and Rosenberg 1984; Weiner et al. 1986b; Mattes et al 1990; Coleman et al. 1996). In essence, patients who benefit the most from ECT in terms of symptomatic response typically report the greatest improvement in subjective evaluations of memory.

A small minority of patients treated with ECT later report that they have suffered devastating consequences (Freeman and Kendell 1980, 1986). Patients may indicate that have dense amnesia extending far back into the past for events of personal significance and/or that broad aspects of cognitive function are impaired such that they are no longer able to engage in former occupations. The rarity of these subjective reports of profound cognitive deficits makes determination of their absolute base rates difficult. Multiple factors likely contribute to these perceptions by former patients.

First, in some patients self-reports of profound ECT-induced deficits may be accurate. As noted, as with any medical intervention, there are individual differences in the magnitude and persistence of ECT’s cognitive effects. In rare cases, ECT may result in a more dense and persistent retrograde amnesia that extends back to years prior to the treatment.

Second, some of the psychiatric conditions treated with ECT result in cognitive deterioration as part of their natural history. This may be particularly likely in young patients in their first psychotic episode (Wyatt 1991, 1995), and in older patients where ECT may unmask a dementing process. While in such cases, cognitive deterioration would have occurred inevitably, the experience of transient short-term side effects with ECT may sensitize patients to attribute the persistent changes to the treatment (Squire 1986; Sackeim 1992).

Third, as noted above, subjective evaluations of cognitive function typically show poor association with objective measurement and strong association with measures of psychopathology (Coleman et al. 1996). Only one study recruited patients with long-term complaints about effects of ECT and compared them to two control groups (Freeman et al. 1980). Objective neuropsychological differences among the groups were slight, but there were marked differences in assessments of psychopathology and medication status. Patients who reported persistent deficits due to ECT were less likely to have benefited from the treatment, and were more likely to be presently symptomatic and receiving psychotropic treatment (Freeman et al. 1980; Frith et al. 1983).

Recommendations

5. 1. General

a) Physicians administering ECT should be aware of the principal adverse effects which may accompany its use.

b) The type, likelihood, and persistence of adverse effects should be considered on a case-by-case basis in the decision to recommend ECT and in the informed consent process (see Chapter 8 ).

c) Efforts should be made to minimize adverse effects by optimization of the patient’s medical condition prior to treatment, appropriate modifications in ECT technique, and the use of adjunctive medications (see also Section 4.1).

5.1.1. Cardiovascular Complications

a) The electrocardiogram (ECG) and vital signs (blood pressure, pulse, and respiration) should be monitored during each ECT treatment to detect cardiac arrythmias and hypertension (see Section 11.8).

b) b) The ECT treatment team should be prepared to manage the cardiovascular complications known to be associated with ECT. Personnel, supplies, and equipment necessary to perform such a task should be readily available (see Chapters 9 and 10).

5.1.2. Prolonged Seizures

Each facility should have policies outlining the steps to be taken to terminate prolonged seizures and status epilepticus (see Section 11.9.4).

5.1.3 Prolonged Apnea

Resources for maintaining an airway for an extended period, including intubation, should be available in the treatment room (see Chapters 9 and 10).

Systemic Side Effects

Headache and nausea are the most common systemic side effects of ECT. Systemic side effects should be identified and symptomatic treatment considered.

5.3 Treatment Emergent Mania

Instances in which patients switch from depressive or affectively mixed states into hypomania or mania during a course of ECT should be identified, and a determination to continue or suspend further treatment with ECT.

5.4. Cognitive Dysfunction

a) Orientation and memory function should be assessed prior to ECT and periodically throughout the ECT course to detect and monitor the presence of ECT-related cognitive dysfunction (see Section 12.2.1 for details). This assessment should attend to patient self-reports of memory difficulty.

b) Based on the assessment of the severity of cognitive side effects, the physician administering ECT should take appropriate action. The contributions of medications, ECT technique, and spacing of treatments should be reviewed. Potential treatment modifications include changing from bilateral to right unilateral electrode placement, decreasing the intensity of electrical stimulation, increasing the time interval between treatments, and/or altering the dosage of medications, or, if necessary, terminating the treatment course.

Table 1. Treatment factors that may increase or decrease the severity of adverse cognitive side effects

Treatment factor
Associated with increased
cognitive side effects
Steps to be taken to reduce
cognitive side effects
Stimulus waveform
Sine wave
Change to brief pulse
Electrode placement
Bilateral
Change to right unilateral
Stimulus intensity
Grossly suprathreshold
Decrease electrical dose
Spacing of treatments
ECT administered 3-5 times
per week
Decrease frequency or stop
ECT
Number of seizures per session
Multiple (two ore more) seizures
per session
Change to conventional
ECT
Concomitant psychotropic
medications
Lithium, benzodiazepines,
neuroleptics, antidepressants
Reduce dose or stop
psychotropics
Anesthetic medications
High dose may contribute to
amnesia
Reduce dose as appropriate for
light level of anesthesia

Chapter 6. Pre-ECT Evaluation

Although components of the evaluation of patients for ECT will vary on a case-by-case basis, each facility should have a minimal set of procedures to be undertaken in all cases (Coffey 1998). A psychiatric history and examination, including past response to ECT and other treatments, is important to ensure that an appropriate indication for ECT exists. A careful medical history and examination, focusing particularly on neurological, cardiovascular, and pulmonary systems, as well as upon effects of previous anesthesia inductions, are crucial to establishing the nature and severity of medical risks. Inquiry about dental problems and a brief inspection of the mouth, looking for loose or missing teeth and noting the presence of dentures or other appliances should be carried out. The evaluation of risk factors prior to ECT should be performed by individuals privileged to administer ECT and ECT anesthesia. Findings should be documented in the clinical record by a note summarizing the indications and risks and suggesting any additional evaluative procedures, alterations in ongoing medications (see Chapter 7), or modifications in ECT technique that may be indicated. Procedures for obtaining informed consent should be carried out (see Chapter 8 ).

Laboratory tests required as part of the pre-ECT workup vary considerably. Young, physically healthy patients may not require any laboratory evaluation. Nevertheless, common practice is to perform a minimum screening battery of tests, often including a CBC, serum electrolytes, and an electrocardiogram. A pregnancy test should be considered on women of childbearing age, although ECT is not generally of increased risk in pregnant women (see Section 4.3). Some facilities have protocols whereby laboratory tests are specified on the basis of age or certain medical risk factors such as cardiovascular or pulmonary history (Beyer et al. 1998). Spine x-rays are no longer routinely necessary, now that the risk of musculoskeletal injuries with ECT has been largely obviated by the use of muscular relaxation, unless pre-existing disease affecting the spine is suspected or known to exist. EEG, brain computed tomography (CT), or magnetic resonance imaging (MRI) should be considered if other data suggest that a brain abnormality may be present. There is now some evidence that abnormalities found on structural brain images or EEG may be useful in modifying treatment technique. For example, since subcortical hyperintensities on MRI have been linked to a greater risk of post-ECT delirium (Coffey 1996; Coffey et al. 1989; Figiel et al. 1990), such a finding might encourage the use of right unilateral electrode placement and conservative stimulus dosing. Likewise, the finding of generalized slowing on a pre-ECT EEG, which has been linked to greater post-ECT cognitive impairment (Sackeim et al. 1996; Weiner 1983) might also encourage the above technical considerations. The potential use of pre-ECT cognitive testing is discussed elsewhere (See Section 12.2).

Although no data exist on the optimal interval in time between the pre-ECT evaluation and the first treatment, the evaluation should be performed as close as possible to the initiation of treatment, keeping in mind that it often must be spread over a number of days, due to need for specialty consultations, waiting- for laboratory results, meetings with patient and significant others, and other factors. The treatment team should be aware of pertinent changes in the patient’s condition over this time interval and should initiate further evaluation as indicated.

The decision to administer ECT is based on the type and severity of the patient’s illness, treatment history, and a risk-benefit analysis of available psychiatric therapies, and requires agreement among attending physician, ECT psychiatrist, and consentor. Medical consultation is sometimes used to obtain a better understanding of the patient’s medical status, or when assistance in the management of medical conditions is desirable. To ask for “clearance” for ECT, however, makes the assumption that such consultants have the special experience or training required to assess both risks and benefits of ECT as compared to treatment alternatives — a requirement that is unlikely to be met. Likewise, determinations made by individuals in administrative positions regarding the appropriateness of ECT for specific patients are inappropriate and compromise patient care.

RECOMMENDATIONS:

Local policy should determine the components of the routine pre-ECT evaluation. Additional tests, procedures, and consultations may be indicated, on an individual basis. Such a policy should include all the following:

1. psychiatric history and examination to determine the indication for ECT. The history should include an assessment of the effects of any prior ECT.

2. a medical evaluation to define risk factors. This should include medical history, physical examination (including assessment of the teeth and mouth), and vital signs.

3. an evaluation by an individual privileged to administer ECT (ECT psychiatrist –Section 9.2), documented in the clinical record by a note summarizing indications and risks and suggesting any additional evaluative procedures, alterations in ongoing medications, or modifications in ECT technique that may be indicated.

4. anesthetic evaluation, addressing the nature and extent of anesthetic risk and advising of the need for modification in ongoing, medications or anesthetic technique.

5. informed consent (see Chapter 8 ).

6. appropriate laboratory and diagnostic tests. Although there are no absolute requirements for laboratory tests in a young, healthy patient, a hematocrit, serum potassium and an electrocardiogram should be considered in most patients. Consideration should be given to performing a pregnancy test in women of childbearing age prior to the first ECT. More extensive laboratory evaluation may be indicated, depending on the patients’ medical history or current status.

Chapter 8: Consent for ECT

8.1 General

“The core notion that decisions regarding medical care are to be made in a collaborative manner between patient and physician” has, over the last few decades, evolved into a formal legal doctrine of informed consent (Appelbaum et al. 1987, p. 12). Such doctrine serves to focus on a number of important questions regarding the nature of consent to treatment. What is informed consent? Who should provide consent, and under what circumstances? How, and by whom, should capacity for consent be determined? What information should be provided to the consentor and by whom? And how should consent be managed with incompetent or involuntary patients? General reviews of informed consent issues as they relate to ECT can be found in Parry (1986), Roth (1986), Taub (1987), and Winslade (1988), while capacity for consent and the use of ECT in incompetent and/or involuntary patients is specifically addressed in Roth et al. (1977), Salzman (1977), Culver et al. (1980), Roy-Byrne and Gerner (1981), Gutheil and Bursztajn (1986), Mahler et al. (1986), Applebaum et al. (1987), Wettstein and Roth (1988), Levine et al (1991), Reiter-Theil (1992), Martin and Bean (1992), Martin and Clancy (1994), Bean et al (1994), and Boronow et al (1997).

The psychiatric profession, both in the United States and elsewhere, has made a number of attempts to offer practical guidelines for the implementation of consent in the clinical setting. In this regard, the conceptual requirements for informed consent posed by the 1978 APA Task Force on ECT are still applicable; 1) a patient who is capable of understanding and acting reasonably upon such information, 2) the provision of adequate information, and 3) the opportunity to consent in the absence of coercion (American Psychiatric Association 1978). Specific recommendations concerning consent for ECT often reflect a trade-off between the preservation of the autonomy of the patient and the assurance of the patient’s right to receive treatment (Ottosson 1992).

A crucial hallmark of informed consent is the quality of interactions between the consentor and the physician, particularly since consent for ECT is an ongoing process. In general, the more the physician keeps the consentor abreast of what is transpiring and involves the consentor in everyday decision making, and the more he/she is sensitive to the consentor’s concerns and feelings regarding, these decisions, the fewer problems there will be with the consent process.

8.2 The Requirement for Consent.

Since informed consent for ECT is mandated, both ethically and by regulation, it is incumbent upon facilities using ECT to implement and monitor compliance with reasonable and appropriate policies and procedures. Although the practitioner legally obliged to follow state and local regulatory requirements concerning consent for ECT, judicial and political efforts should be made to correct overregulation (Winslade et al. 1984; Taub 1987). In this regard, ECT should not be considered different from other medical or surgical procedures with comparable risks and benefits. Regulations should not unduly obstruct the patient’s right to treatment, since unnecessary suffering, increased physical morbidity, and even fatalities may result if procedures to provide ECT to incompetent or involuntary patients (see below) are needlessly prolonged (Mills and Avery 1978; Roy-Byrne and Gerner 1981; Tenenbaum 1983; Walter-Ryan 1985; Miller et al. 1986; Johnson 1993).

8.3 When and by Whom Should Consent Be Obtained?

As with consent for medical and surgical procedures, the patient should provide informed consent unless lacking capacity or otherwise specified by law. The involvement of significant others in this process should be encouraged (Consensus Conference 1985) but not required (Tenenbaum 1983).

ECT is unusual, but not unique, among medical procedures in that it involves a series of repetitive treatments over an appreciable time period (typically 2 to 4 weeks for an acute ECT course). Because it is the series of treatments, rather than any single treatment, that confers both the benefits and adverse effects of ECT, consent should apply to the treatment series as a whole (unless otherwise required by state law).

Since an ECT course generally extends over multiple weeks, the informed consent process should continue across this period. Patient recall of consent for medical and surgical procedures is commonly faulty (Roth et al. 1982; Miesel and Roth 1983; Herz et al 1992; Hutson and Blaha 1991; Swan and Borshoff 1994). For patients receiving ECT, this recall difficulty may be exacerbated by both the underlying illness and the treatment itself (Sternberz and Jarvik 1976; Squire 1986). For these reasons, the consentor should be provided ongoing feedback regarding clinical progress and side effects and any questions should be addressed. Particularly if the consentor expresses reluctance about receiving ECT, h/she should be reminded of his/her right to accept or refuse further treatment.

Continuation/maintenance ECT (see Chapter 13) differs from a course of ECT in that (1) its purpose is the prevention of relapse or recurrence, (2) the patient’s clinical condition is improved compared to that preceding the index ECT course, and (3) it is characterized by both a greater inter-treatment interval and a less well-defined endpoint. Because the purpose of continuation/maintenance treatment differs from an acute course of ECT, a new informed consent process should be initiated, including the signing of a separate consent form. As a series of continuation ECT typically lasts at least 6 months, and because continuation/ maintenance ECT is provided to individuals who are clinically improved and already knowledgeable about the treatment, a 6-month interval is adequate before readministration of the formal consent document (unless state law requires otherwise).

Ideally, the consent process involves discussions with the consentor about general aspects of ECT and information unique to the patient, as well as the signing of the informed consent document. The information essential to consent to ECT should be provided by a knowledgeable physician. Ideally, this person should also have a therapeutic alliance with the patient. In practice this requirement can be accomplished by the attending physician, treating psychiatrist, or other knowledgeable physician acting individually or in concert. It may also be helpful for other, professional staff to provide further information to the consentor. Consent for anesthesia may either be included in the ECT consent process or separately obtained by an anesthetist.

8.4 Information to Be Conveyed

The use of a formal consent document for ECT ensures the provision of essential information to the consentor. Earlier task force recommendations (American Psychiatric Association 1978, 1990), other professional Guidelines, and regulatory requirements (Mills and Avery 1978; Tenenbaum 1983); Winslade et al. 1984; Taub 1987; Winslade 1988) have encouraged the use of comprehensive written information about ECT as part of the consent process. Such material may either be contained wholly within the formal consent document, or included as a patient information supplement. In either case, informational material should be given to the consentor to keep. In surgical patients, patient information supplements have been shown to significantly enhance recall of information provided prior to surgery (Askew et al 1990).

Sample consent forms and supplementary patient information material are included in Appendix B. If these documents are used, appropriate modifications should be made to reflect local requirements. It is also suggested that reproductions be in large type, to ensure readability by patients with poor visual acuity. To further enhance the understanding of ECT, many practitioners now augment written materials with use of videotapes designed to cover the topic of ECT from the layman’s perspective (Baxter et al. 1986; Guze et al. 1988; Battersby et al. 1993; Dillon 1995; Westreich et al. 1995). A listing of such materials has been included as part of Appendix C.

However, to rely entirely upon such generic materials as the sole informational component of the informed consent process would be ill advised. Even with considerable attention to readability, many patients understand less than half of what is contained in a typical medical consent form (Roth et al. 1982). In this regard, it is interesting to note that psychiatric patients do not perform more poorly than medical or surgical patients (Miesel and Roth 1983). Because of this situation, in addition to written information given to the patient, a discussion between the consentor and a knowledgeable physician should take place. This discussion should summarize the main features of the consent document, provide additional information applicable to that individual, and allow a further opportunity for the consentor to express opinions and have questions answered. Examples of individual-specific information include: the rationale for ECT, reasonable treatment alternatives, specific benefits and risks, and any major alterations planned in the ECT procedure. This discussion should also be briefly summarized in the patient’s clinical record.

Substantial alterations in the treatment procedure or other factors having a major effect upon risk-benefit considerations should be conveyed to the consentor on a timely basis and documented in the patient’s clinical record. The need for ECT treatments exceeding the typical range (see Section 11.11) and the switching of stimulus electrode placement (see Section 11.6) represent two such examples.

Informational material provided as part of the consent process should be sufficient in scope and depth to allow a reasonable person to understand and evaluate the risks and benefits of ECT as compared to treatment alternatives. Since individuals vary considerably in education and cognitive status, efforts should be made to tailor information to the consentor’s ability to comprehend such data. In this regard, the practitioner should be aware that too much technical detail can be as counterproductive as too little. The readability of consent forms should be no greater than at a 10th grade level to optimize comprehension (some contemporary word processing software packages capable of easily determining readability – the consent documents in Appendix B meet this criterion).

Topics to be covered in the consent document generally include the following:

1) a description of the ECT procedure, including the times when treatments are given (e.g., Monday, Wednesday, Friday mornings , general location of treatment (i.e., where treatments will take place), and typical range for number of treatments to be administered

2) why ECT is being recommended and by whom

3) that there is no guarantee that ECT will be effective

4) that there is generally a substantial risk of relapse following ECT, and that continuation treatment of some sort is nearly always indicated

5) a generic mention of applicable treatment alternatives

6) the likelihood (e. g., “extremely rare,” “rare,” “uncommon,” or “common”), and anticipated severity of major risks associated with the procedure (see Chapter 5), including mortality, adverse effects upon cardiovascular and central nervous systems (including both transient and persistent amnesia), and common minor side-effects. In light of the accumulated body of data dealing with structural effects of ECT (Devenand et al 1994), “brain damage” should not be included as a potential risk.

7) an acknowledgement that consent for ECT also implies consent for appropriate emergency treatment in the event that this is clinically indicated

8) a description of behavioral restrictions that may be necessary during the pre-ECT evaluation period, the ECT course, and the recuperative interval

9) 10) a statement that consent for ECT is voluntary and can be withdrawn at any time

11) 10) an offer to answer questions at any time regarding the recommended treatment and the name of whom to contact for such questions

8.5 Capacity to Provide Voluntary Consent.

Informed consent requires that a patient be capable of understanding and acting reasonably upon information provided to him/her about the procedure. For the purpose of these recommendations, the term “capacity” reflects this criterion. There is no clear consensus as to what constitutes “capacity to consent.” Criteria for capacity to consent have tended to be vague, and formal “tests” of capacity are only now under active investigation (Bean et al 1996; Grisso and Appelbaum 1995; Martin et al 1994). It is suggested, instead, that the individual obtaining consent consider the following general principles in making a determination. First, capacity to consent should be assumed to be present unless compelling evidence to the contrary exists. Second, the occurrence of psychotic ideation., irrational thought processes, or involuntary hospitalization do not in themselves constitute such evidence. Third, the patient should demonstrate sufficient comprehension and retention of information so that he/she can reasonably make a decision whether or not to consent for ECT.

Unless otherwise mandated by statute, a determination of capacity is generally made by the attending physician. First, the attending physician is in an excellent position to assess the patient’s ability to meet the above three criteria for capacity to consent. Also, the attending physician is likely to be aware of how the patient’s mental illness affects these criteria. Finally, the attending physician is generally the one who makes such determination with respect to other medical and surgical procedures. Should the attending physician be in doubt as to whether capacity to consent is present, use may be made of an appropriate physician consultant not otherwise associated with the patient’s care.

There is concern that attending physicians may be biased to find that capacity to consent exists when the patient’s decision agrees with their own. In this regard, however, ECT is no different from other treatment modalities. Fixed requirements for a priori review of capacity to consent for ECT by consultant, special committee, appointed lawyer, or judicial hearing are impediments to the patient’s right to treatment and are inappropriate.

Patients who have previously been adjudicated legally incompetent or medical purposes usually have consent provided by a legally appointed guardian or conservator, although this may vary depending upon jurisdiction.

For patients with capacity to consent, ECT should only be administered with the agreement of the patient. To do otherwise would infringe upon the right to refuse treatment. Situations where the patient lacks capacity to consent for ECT are generally covered by regulations which include how and from whom surrogate consent may be obtained. In such instances, all the information typically provided regarding ECT and alternative treatment should be shared with this individual.

Informed consent is defined as voluntary when the consentor’s ability to reach a decision is free from coercion or duress. Since the treatment team, family members, and friends all may have opinions concerning whether or not ECT should be administered, it is reasonable that these opinions and their basis be expressed to the consentor. In practice, the line between “advocacy” and “coercion” may be difficult to establish. Consentors who are either highly ambivalent or are unwilling or unable to take full responsibility for the decision (neither of which are rare occurrences with patients referred for ECT) are particularly susceptible to undue influence. Staff members involved in clinical case management should keep these issues in mind.

Threats of involuntary hospitalization or precipitous discharge from the hospital due to ECT refusal clearly represent undue influence. However, consentors do have the right to be informed of the anticipated effects of their actions on the clinical course and the overall treatment plan. Similarly, since physicians are not expected to follow treatment plans which they believe are ineffective or unsafe, an anticipated need to transfer the patient to another attending physician should be discussed in advance with the consentor. It is important to understand the issues involved in a consentor’s decision to refuse or withdraw consent. Such decisions may sometimes be based upon misinformation or may reflect unrelated matters, e.g., anger towards self or others or a need to manifest autonomy. In addition, a patient’s mental disorder can itself limit the ability to cooperate meaningfully in the informed consent process, even in the absence of psychosis.

A number of suggestions have been offered to help guarantee the right of involuntarily hospitalized patients to accept or refuse specific components of the treatment plan, including ECT. Examples of such recommendations include the use of psychiatric consultants not otherwise involved in the patient’s care, appointed lay representatives, formal institutional review committees, and legal or judicial determination. While some degree of protection is indicated in such cases, overregulation will serve to limit unnecessarily the patient’s right to receive treatment.

RECOMMENDATIONS

8. 1. General

a) Policies and procedures should be developed to assure proper informed consent, including when, how, and from whom it is to be obtained, and the nature and scope of information to be provided.

b) These policies and procedures should be consistent with state and local regulations.

8.2. The Requirement for Consent

a) Informed consent should be obtained from the patient except in situations where the patient lacks capacity to do so (see Section 8.5.3).

b) Informed consent for ECT is given for a specified treatment course or for a period of continuation/maintenance ECT (see Section 13.3).

c) Consent for future treatments may be withdrawn at any time, including, between ECT treatments, by the individual providing consent.

8.3. When and by Whom Should Consent Be Obtained?

a) Informed consent for ECT, including the signing of a formal consent document, should be obtained before beginning an ECT treatment course or a period of continuation or maintenance ECT. In the latter case, the consent process should be repeated at least every six months.

b) Informed consent should be obtained by the patient’s attending physician, treating psychiatrist or other physician knowledgeable about both the patient and ECT (unless otherwise specified by law).

c) When separate informed consent for ECT anesthesia is required, it should be obtained by a privileged or otherwise authorized anesthesia provider.

d) The consentor should be provided ongoing feedback regarding clinical progress and side effects and any questions or concerns should be addressed.

e) If the consentor expresses reluctance about the treatment at any time prior to or during the ECT course, h/she should be reminded of his/her right to accept or refuse treatment.

8.4. Information to Be Conveyed

8.4.1. General Considerations

a) Information describing ECT (see below) should be conveyed in a written consent document. This document and/or a summary of general information related to ECT should be given to the consentor to keep (examples are provided in Appendix B). The use of a separate consent document may be required for anesthesia with ECT in certain settings.

b) The use of appropriate video format patient information on ECT is encouraged.

c) In addition to the written consent document an overview of general information on ECT and individual-specific data should be presented orally by the attending physician, treating psychiatrist, or other knowledgeable physician. Further information may also be provided by other staff members.

d) The consentor should be informed if substantial alterations in the treatment procedure arise that may have a major effect upon risk-benefit considerations.

e) Significant discussions with the consentor regarding these issues should be documented in the clinical record.

f) All information should be provided in a form understandable to the consentor, and should be sufficient to allow a reasonable person to understand the risks and benefits of ECT and to evaluate the available treatment options.

g) The consentor should have an opportunity to ask questions relevant to ECT or treatment alternatives.

8.4.2. Specific Information Provided

The consent document should provide:

a) a description of ECT procedures including:

1) when, where, and by whom the treatments will be administered

2) a range of the number of treatment sessions likely

3) a brief overview of the ECT technique itself.

b) a statement of why ECT is being recommended and by whom, including a general consideration of treatment alternatives.

c) a statement that, as with any treatment modality, therapeutic (or prophylactic) benefits associated with ECT may be absent or transient.

d) a statement indicating the need for continuation therapy.

e) a statement as to the likelihood and severity (in general terms) of the risks related to anesthesia and seizure induction: including mortality, cardiac dysfunction, confusion, acute and persistent memory impairment, musculoskeletal and dental injuries, headaches, and muscle pain.

f) a statement that, as with any other procedure involving general anesthesia, consent for ECT also implies consent to perform appropriate emergency medical interventions in the unlikely event that this proves necessary during the time the patient is not fully conscious.

g) a statement that consent is voluntary and can be revoked at any time before or during the treatment course.

h) a statement that the consentor is encouraged to ask questions at any time regarding ECT, and whom to contact for such questions.

1) a description of any restrictions on patient behavior that are likely to be necessary before, during,, or following ECT.

8.5. Capacity to Provide Voluntary Consent

8.5.l. General Considerations

a) The use of ECT requires voluntary consent from an individual with capacity to make such a decision.

b) Individuals with mental illness are considered to have the capacity to consent to ECT unless the evidence to the contrary is compelling. The presence of psychosis, irrational thinking, or involuntary hospitalization do not in themselves constitute proof of lack of capacity.

c) Unless otherwise specified by statute, the determination of capacity to consent should generally be made by the patient’s attending physician, with use of an appropriate physician consultant not otherwise associated with the patient’s care in cases where the attending physician is uncertain as to whether capacity to consent is present.

d) In the event of refusal or withdrawal of consent to ECT, the attending physician and/or treating, psychiatrist should inform the consentor of anticipated effects of this action upon clinical course and treatment planning.

8.5.2. Patients Having the Capacity to Provide Consent

In this case, ECT should only be administered in the presence of voluntary patient agreement, including signing of a formal consent document.

8.5.3. Patients Lacking the Capacity to Provide Consent

State and local law covering consent to treatment for patients lacking the capacity to provide such consent should be followed, including statutes pertinent to emergency situations where a delay in treatment may lead to death or serious impairment in health. Applicable legal requirements vary considerably by jurisdiction and are subject to revision over time. Surrogate decision makers should be provided with the information described above. Consideration should be given to any positions previously expressed by the patient when in a state of determined or presumed capacity, as well as to the opinions of major significant others.

12. Evaluation of Outcome

12.1. Therapeutic Response

Before beginning an acute or index course of ECT, each patient should have a documented treatment plan, indicating specific criteria for remission. The type and severity of prominent symptomatology should be described. It is helpful for therapeutic goals to take into account the aspects of symptomatology that are expected to improve. For example, some patients with schizoaffective disorder present with relatively chronic forms of thought disturbance (e.g., delusions), with prominent superimposed episodes of affective symptomatology. In a number of these patients, ECT may ameliorate the affective component without influencing the chronic thought disturbance. Prolonging the ECT course because of persistent thought disturbance may result in unnecessary treatment. In contrast, many patients with mood disorder present with chronic dysthymia preceding a clear-cut episode of major depression. Some practitioners may be uncertain whether remission of a major depressive episode is associated with return to the chronic dysthymia or whether dysthymic symptomatology also responds to ECT. There is evidence that the extent of residual symptomatology shortly following ECT does not differ among patients with a double depression(i.e., major depression superimposed on dysthymia) and patients with major depression without a history of dysthymia (Prudic et al. 1993). Thus, in patients with double depression, basing treatment termination only on resolution of the major depressive episode may result in incomplete treatment, and possibly heighten the risk of relapse.

After the start of ECT, clinical assessments should be performed and documented attending physician or designee after every one or two treatments. To allow for clearing of acute cognitive side effects, it is preferable to conduct these assessments at least 24 hours following a treatment. Assessments should document changes in the disorder being treated with ECT, both in terms of improvement in the signs and symptoms that were present initially and the emergence of new symptomatology. Although infrequent, switches from depression to mania may occur during the course of ECT. In this context, it is important to distinguish between mania and a delirium with euphoria (Devanand et al. 1988b) (see also Section 5.3). Serial assessments of cognitive function may help in making this differential diagnosis.

In patients treated for catatonia, the nature of other symptoms may have been difficult to discern at pretreatment due to mutism or negativism. After catatonic symptoms improve with ECT, other aspects of psychopathology may become evident and should be assessed and documented. Other patients may have experienced delusions or hallucinations before or during the ECT course, but these symptoms may have been difficult to verify due to patient guardedness or other factors. With clinical improvement, additional symptoms may become apparent, impacting on future treatment.

Some practitioners find it useful to use a standardized rating instrument when assessing symptomatic change. Changes in rating scale scores over time are particularly helpful in determining whether the degree of improvement has accelerated, decelerated, or plateaued and in documenting the extent of residual symptomatology at the completion of ECT. For patients with major depression, the Hamilton Rating Scale for Depression (HRSD, Hamilton 1967) is a commonly used instrument. The 24-item version of the HRSD contains items assessing symptoms of hopelessness, helplessness, and worthlessness, features that are particularly common in patients receiving ECT. An alternative instrument is the Montgomery-Asberg Depression Rating Scale (MADRS) (Montgomery and Asberg 1979). For patients with psychotic disorder, clinician assessments of symptomatology may be performed with the Brief Psychiatric Rating Scale (Overall and Gorham 1962). The Young Mania Rating Scale (Young et al. 1978) may be used for patients with acute mania. It should be noted that the instructions used with instruments such as the HRSD traditionally assess symptomatology over the past week. Since symptomatic change with ECT is often rapid and requires more frequent assessment, it is useful to reduce the interval being examined to a few days.

Prior to ECT, clinician and self-report assessments of depression severity show only moderate correlation (Sayer et al. 1993). This discrepancy is largely attributable to a subgroup of patients who clinicians rate as moderately or severely depressed, but have low levels of symptomatology by self-report. These patients most commonly present with psychotic depression (Sayer et al. 1993). Following completion of ECT, the degree of agreement between self- and clinician-rated assessments is considerably greater. Some clinicians find that a formal self-report instrument is of supplemental value in documenting the effects of ECT on symptomatology. The Beck Depression Inventory II (Beck et al. 1996; Dozois et al. 1998) may be used, with the period being assessed modified from two weeks to at most one week. An alternative self-rating instrument is the Inventory Depressive Symptomatology (IDS-SR, Rush et al. 1985), which has the advantage of having a complementary clinician rated version. It should be noted, however, that self-ratings of depression seventy are supplemental, and should never substitute for clinician evaluations.

Before using ECT as a continuation treatment, the type and severity of residual symptomatology following acute phase treatment should be ascertained. As with acute phase treatment, the ECT physician should interview the patient before each continuation treatment to determine changes in symptoms and cognition. Emergence of symptoms suggestive of potential relapse should trigger consideration of changes in treatment frequency and/or technique.

12.2. Adverse Effects

Cognitive changes. The impact of ECT on cognition, particularly orientation and memory, should be assessed both in terms of objective findings and patient report during and following the ECT course (see Sections 5.4 and 5.5). This assessment should be conducted before the start of ECT to establish a baseline level of functioning, and should be repeated at least weekly throughout the ECT course. It is suggested that cognitive assessment, like assessment of therapeutic change, be conducted at least 24 hours following an ECT treatment to avoid contamination by acute postictal effects.

The evaluation of cognitive function may include either bedside assessment and/or formal neuropsychological measures. In either case, cognitive assessment should minimally include evaluations of orientation, anterograde amnesia, and retrograde amnesia. For bedside or informal assessment, orientation in the three spheres (person, place and time) should be determined. Informal assessment of anterograde and retrograde amnesia can be conducted by discussion with the patient of events in the recent and distant past (e.g., events associated with the day of the interview, recent trips or special occasions, and memory for personal details, such as address, phone number, etc.).

Formal testing instruments provide quantitative measures for tracking change. To assess global cognitive functioning, including orientation, an instrument such as the Mini-Mental State exam (MMSE, Folstein et al. 1975) may be used. Significantly diminished MMSE scores (e.g., reductions of 20% or more) may reflect or suggest the development of a sustained delirium and lead to consideration of modifications in ECT technique. Similarly, such reductions following the end of the ECT course may have implications for discharge planning and for the level of supervision required following ECT. It should be noted, however, that changes in global cognitive status, as measured by the MMSE, are not necessarily associated with the degree of anterograde or retrograde amnesia. Patients may show unchanged or improved MMSE scores and still manifest considerable amnesia (Sobin et al. 1995).

A variety of instruments are available to assess delayed recall of newly learned information. These include subtests of the Weschsler Memory Scale III (WMS-III, Weschsler, 1997) which provides age-adjusted norms for delayed memory components. Unfortunately, there are no alternative versions of the WMS-III, and repeated assessment may be confounded by practice effects. In contrast, the Randt Memory Test (Randt et al. 1980; Randt and Brown, 1983)subscales that assess delayed memory for verbal and pictorial material have shown sensitivity to the anterograde amnesia associated with ECT (Zervas and Jandorf, 1993), and this instrument has five alternative forms. When used with a delay recall procedure, the Buschke Selective Reminding Test (Hannay and Levin 1985), is also useful for repeated assessment (Sackeim et al. 1993). Tasks involving delayed copying of complex figures (Lezak, 1995), delayed recognition memory for unfamiliar faces, and the Benton Visual Retention Test (Benton. 1950; Sivan, 1992) have shown sensitivity to ECT associated anterograde amnesia for nonverbal information (Meyendorf et al. 1980; Steif et al. 1986; Weiner et al. 1986; Sackeim et al. 1993).

Brief and valid assessment instruments to gauge the extent of retrograde amnesia are less readily available. Tests that formally assess recall and/or recognition of famous people or public events (e.g., Butters and Albert 1982; Goldberg and Barnett, 1985) have been used (Squire 1986; Weiner et al. 1986). However, most of these instruments categorize events in relation to the decade of their prominence (e.g., 90=s, 80=s, 70=s). The retrograde amnesia resulting from ECT displays a temporal gradient, such that events closest in time to the treatment course are most vulnerable to memory loss and remote events are spared (Squire et al. 1975; Squire 1986; Sackeim 1992). Consequently, these instruments are unlikely to be sufficiently sensitive.

An alternative approach has been to assess amnesia for autobiographical or personal memories (Weiner et al. 1986; Sackeim et al. 1993; McElhiney et al. 1995: Sobin et al. 1995). Memory loss for events in the patient’s life is often the most distressing aspect of ECT’s cumulative side effects. Unfortunately, the instruments shown to be sensitive in research are lengthy and generally not amenable to routine clinical use. Efforts are underway to validate a brief instrument that may be sensitive to ECT-induced retrograde amnesia for autobiographical information.

When cognitive status is assessed formally or informally, the patient’s perception of cognitive changes should also be ascertained. This assessment may be done by informally inquiring whether the patient has noticed any changes in the ability to concentrate (e.g. to follow a television program or a magazine article), to remember visitors or events of the day, or to recall more remote events. Patient perception of memory functioning may also be examined using a quantitative instrument. The Squire Memory Complaint Questionnaire (Squire et al. 1979) has been used most commonly with patients receiving ECT.

As noted in Section 5.5, recent studies have repeatedly found that patients report fewer memory complaints shortly following the ECT course relative to their preECT baseline (Coleman et al. 1996). T he changes in self-reported cognitive function are independent of changes in objective neuropsychological measures, but correlate substantially with degree of improvement in depressive symptomatology (Cronholm and Ottosson 1963; Frith et al 1983; Squire and Slater 1983; Weiner et al 1986; Squire and Zouzounis 1988; Calev et al. 1991; Coleman et al. 1996). Some concerns have been raised about the reliability of the Squire Memory Complaint Questionnaire, as it requires patients to assess their current cognitive functioning relative to their functioning prior to onset of the psychiatric episode, a complex judgment (Coleman et al. 1996). The Cognitive Failures Questionnaire (Broadbent et al. 1982) is an alternative self-report instrument, with a broader sampling of aspects of cognitive function.

In the event of substantial deterioration in orientation or memory functioning during the ECT course that is unresolved upon hospital discharge, a plan should be made for follow-up of cognitive status. The plan should include a description of when follow-up assessment would be desirable, as well as the specific domains of cognitive function to be assessed. Most commonly cognitive functioning recovers markedly in within days of the end of the ECT course (Stelf et al. 1986) and patients should be reassured that this will likely be the case.

It should be kept in mind that the suggested evaluation procedures provide only gross measures of cognitive status. Furthermore, interpretation of cognitive change may be subject to a number of difficulties. Patients frequently have cognitive impairments before receiving ECT (Sackeim and Steif 1988) and therapeutic response may be associated with improvement in many cognitive domains (Weeks et al. 1980; Malloy et al. 1982; Frith et al. 1983; Sackeim et al. 1992, 1993). However, while some patients show improved scores relative to their preECT baseline, they still may not have fully returned to their baseline level of cognitive functioning (Steif et al. 1986). This discrepancy may be a basis for complaints about lingering cognitive deficits. In addition, the procedures suggested here only sample limited aspects of cognitive functioning, for example, deliberate (conscious or intentional) learning and retention of information. Patients may also have deficits in incidental (unattended) learning. Likewise, the suggested procedures concentrate on verbal memory, although both right unilateral and bilateral ECT produce deficits in memory for nonverbal material (Squire 1986).

Other adverse effects. During the ECT course, any onset of new risk factors, or significant worsening of those present before ECT, should be evaluated prior to the next treatment. When such developments alter the risks of administering ECT, the consentor should be informed and the results of this discussion documented. Patient complaints about ECT should be considered carefully. The attending physician and/or a member of the ECT treatment team should discuss these complaints with the patient, attempt to determine their source, and ascertain whether corrective measures are indicated.

RECOMMENDATIONS

12. Evaluation of Outcome

12.1. Therapeutic Response

a) Each treatment plan should indicate specific criteria for remission.

b) Clinical assessments should be performed by the attending physician or designee and documented prior to ECT and after every 1-2 ECT treatments, preferably at least 24 hours following the treatment.

c) Formal clinical rating instruments may be useful in to documenting changes in symptomatology over the ECT course.

12.2. Adverse Effects

12.2.1. Cognitive Changes

a) During a course of ECT the presence and severity of disorientation, anterograde amnesia, and retrograde amnesia should be monitored in terms of both objective findings and self-report (see Sections 5.4 and 5.5). This evaluation should consist of bedside assessment of orientation and memory (both retention of newly learned material and recall of recent and remote events) and/or administration of formal neuropsychological measures.

b) Assessment should be carried out prior to ECT and at least weekly throughout an ECT course. When possible, cognitive assessment should be performed at least 24 hours following an ECT treatment.

c) Modifications of the ECT procedure should be considered, if there is substantial deterioration of orientation and/or memory during an ECT course (see Section 5.4.(b)). If such effects remain following completion of the ECT course, a plan should be made for postECT follow-up assessment.

12.2.2. Other Adverse Effects

Any sudden onset of new risk factors, or worsening of previously identified risk factors, should be evaluated prior to the next ECT treatment (see Chapter 5). In this regard, patient complaints concerning ECT should be considered carefully.

CHAPTER 13: Management of Patient’s Post-ECT Course

13. Management of Patient’s Post-ECT Course

13.1. Continuation therapy is traditionally defined as the provision of somatic treatment over the 6 month period following, the onset of remission in an index episode of mental illness (National Institute of Mental Health Consensus Development Panel 1985; Prien & Kupfer 1986; Fava & Kaji 1994). However, individuals referred for ECT are particularly likely to be medication resistant and to display psychotic ideation during the index episode of ‘illness, and the risk of relapse remains high (50-95%) throughout the first year following completion of the ECT course (Spiker et al. 1985; Aronson et al 1987; Sackeim et al 1990a,b, 1993; Stoudemire et al. 1994; Grunhaus et al. 1995). For this reason, we will operationally define the continuation interval as the 12 month period following successful treatment with ECT.

Regardless of its definition, continuation treatment has become the rule in contemporary psychiatric practice (American Psychiatric Association 1993, 1994, 1997). Following completion of the index ECT course, an aggressive program of continuation therapy should be instituted as soon as possible. Occasional exceptions include patients intolerant to such treatment and possibly those with a history of extremely long periods of remission (although compelling evidence, for the latter is lacking).

13.2. Continuation pharmacotherapy. A course of ECT is usually completed over a 2- to 4-week period. Traditional practice, based in part on earlier studies (Seager and Bird 1962; Imlah et all. 1965; Kay et al. 1970) and in part on clinical experience, has suggested continuation treatment of patients with unipolar depression with antidepressant agents (and possibly antipsychotic agents in the presence of psychotic symptoms), patients with bipolar depression with antidepressant and/or mood stabilizer medications; patients with mania with mood stabilizer and possibly antipsychotic agents, and patients with schizophrenia with antipsychotic medications (Sackeim 1994). However, some recent evidence suggests that a combination of antidepressant and mood stabilizer pharmacotherapy might improve the effectiveness of continuation therapy for patients with unipolar depression (Sackeim 1994). It may also be beneficial to discontinue antidepressant medications during the continuation phase of treatment for patients with bipolar depression (Sachs 1996). For patients with major depression episodes, medication dosages during continuation treatment are maintained at the clinically effective dose range for acute treatment, with adjustment up or down depending upon response (American Psychiatric Association 1993). For patients with bipolar disorder or schizophrenia, a somewhat less aggressive approach is utilized (American Psychiatric Association 1994, 1997). Still, the role of continuation therapy with psychotropic drugs after a course of ECT continues to undergo assessment (Sackeim 1994). In particular, disappointingly high relapse rates, especially in patients with psychotic depression and in those who are medication resistant during the index episode (Sackeim et al. 1990a: Meyers 1992; Shapira et al. 1995; Flint & Rifat 1998), compel reevaluation of present practice, and suggest consideration of novel medication strategies or continuation ECT.

13.3. Continuation ECT. While psychotropic continuation therapy is the prevailing practice, few studies document the efficacy of such use after a course of ECT. Some recent studies report high relapse rates even in patients complying with such regimens (Spiker et al. 1985, Aronson et al. 1987; Sackeim, et al. 1990, 1993); Stoudemire et al. 1994). These high relapse rates have led some practitioners to recommend continuation ECT for selected cases (Decina et al. 1987; Kramer 1987b; Jaffe et al. 1990b; McCall et al. 1992). Recent reviews have tended to report surprisingly low relapse rates among patients so treated (Monroe 1991; Escande et al. 1992; Jarvis et al. 1992; Stephens et al. 1993; Favia & Kaji 1994; Sackeim 1994; Fox 1996; Abrams 1997a; Rabheru & Persad 1997). Continuation ECT has also been described as a viable option in contemporary guidelines for long-term management of patients with major depression (American Psychiatric Association 1993), bipolar disorder (American Psychiatric Association 1994), and schizophrenia (American Psychiatric Association 1997).

Recent data on continuation ECT have primarily consisted of retrospective series in patients with major depression (Decina et al. 1987; Loo et al. 1988; Matzen et al. 1988; Clarke et al. 1989; Ezion et al. 1990; Grunhaus et al. 1990; Kramer 1990; Thienhaus et al. 1990; Thornton et al. 1990; Dubin et al. 1992; Puri et al. 1992; Petrides et al. 1994; Vanelle et al. 1994; Swartz et al. 1995; Beale et al. 1996), mania (Abrams 1990; Kellner et al. 1990; Jaffe et al. 1991; Husain et al. 1993; Vanelle et al. 1994; Godemann & Hellweg 1997), schizophrenia (Sajatovik & Neltzer 1993; Lohr et al. 1994; Hoflich et al. 1995; Ucok & Ucok 1996; Chanpattaria 1998), and Parkinson’s Disease (Zervas & Fink 1991; Friedman & Gordon 1992; Jeanneau 1993; Hoflich et al. 1995; Aarsland et al. 1997; Wengel et al. 1998). While some of these investigations have included comparison groups not receiving continuation ECT or have compared use of mental health resources before and after implementation of continuation ECT, controlled studies involving random assignment are not vet available. Still, suggestive evidence that continuation ECT is cost-effective, in spite of the cost per treatment, is particularly promising (Vanelle et al. 1994; Schwartz et al. 1995; Steffens et al. 1995; Bonds et al. 1998). In addition, an NIMH-funded, prospective multi-site study comparing continuation ECT with continuation pharmacotherapy with the combination of nortriptyline and lithium is presently underway (Kellner – personal communication).

Because continuation ECT appears to represent a viable form of continuation management of patients following completion of a successful course of ECT, facilities should offer this modality as a treatment option. Patients referred for continuation ECT should meet the following indications: 1) history of illness that is responsive to ECT; 2) either resistance or intolerance to pharmacotherapy alone or a patient preference for continuation ECT; and 3) the ability and willingness of the patient to receive continuation ECT, provide informed consent, and comply with the overall treatment plan, including the behavioral restrictions that may be necessary.

Since continuation ECT is administered to patients who are in clinical remission, and because long inter-treatment intervals are used, it is typically administered on an ambulatory basis (see Section 11.1). The specific timing of continuation ECT treatments has been the subject of considerable discussion (Kramer 1987b; Fink 1990; Monroe 1991; Scott et al. 1991; Sackeim 1994; Petrides & Fink 1994: Fink et al. 1996; Abrams 1997; Rabheru & Persad 1997; Petrides 1998), but evidence supporting any set regimen is lacking. In many cases, treatments are started on a weekly basis with the interval between treatments gradually extended to a month, depending upon the patient’s response. Such a plan is designed to counteract the high likelihood of early relapse noted previously. In general, the greater the likelihood of early relapse, the more intensive the regimen should be. The use of psychotropic agents during a series of continuation ECT remains an unresolved issue (Jarvis et al. 1990; Thornton et al. 1990; Fink et al. 1996; Petrides 1998). Given the resistant nature of many such cases, some practitioners supplement continuation ECT with such medication in selected cases, particularly in those who have limited benefit from continuation ECT alone. In addition, some practitioners believe that the onset of symptoms of impending relapse in ECT responsive patients undergoing continuation pharmacotherapy alone may represent an indication for a short series of ECT treatments for a combination of therapeutic and prophylactic purposes (Grunhaus et al. 1990), although controlled studies are not yet available to substantiate this practice.

Before each continuation ECT treatment, the attending physician should 1) assess clinical status and current medications, 2) make a determination as to whether the treatment is indicated, and decide the timing of the next treatment. A monthly assessment may be used if continuation treatments are occurring at least twice monthly and the patient has been clinically stable for at least 1 month. In any case, the overall treatment plan, including the role of ECT, should be updated at least quarterly. Informed consent should be renewed no less frequently than every 6 months (see Chapter 8 ). To provide an ongoing assessment of risk factors, an interval medical history, focusing on specific systems at risk with ECT, and vital signs should be done prior to each treatment, with further assessment as clinically indicated. In many settings, this brief evaluation is accomplished by the ECT psychiatrist or anesthetist on the day of the treatment. A full anesthesia pre-operative exam (see Section 6) should be repeated at least every 6 months, and laboratory tests at least annually. Although cognitive effects appear to be less severe with continuation ECT than with the more frequent treatments that are administered during an ECT course (Ezion et al. 1990; Grunhaus et al. 1990; Theinhaus et al. 1990; Thornton et al. 1990; Barnes et al. 1997), monitoring of cognitive function should be done at least every 3 treatments. As discussed in Chapter 12, this may consist of simple bedside assessment of memory function.

13.4. Continuation psychotherapy. For some patients, individual or group psychotherapy may be useful in dealing with underlying psychodynamic issues, in facilitating better ways to cope with stressors that might otherwise precipitate a clinical relapse, in assisting the patient to re-organize his/her social and vocational activities, and in encouraging a return to normal life.

Maintenance therapy. Maintenance therapy is empirically defined herein as the prophylactic use of psychotropics or ECT longer than 12 months past the onset of remission in the index episode. Maintenance treatment is indicated when attempts to stop continuation therapy have been associated with symptom recurrence, when continuation therapy has been only partially successful, or when a strong history of recurrent illness is present (Loo et al. 1990; Thienhaus et al. 1990; Thornton et al. 1990; Vanelle et al. 1994; Stiebel 1995). The specific criteria for maintenance ECT, as opposed to maintenance psychotropic therapy, are the same as those described above for continuation ECT. The frequency of maintenance ECT treatments should be kept to the minimum compatible with sustained remission, with re-evaluation of the need for extension in the treatment series and repeated application of informed consent procedures performed at the intervals listed above for continuation ECT.

RECOMMENDATIONS

13.1. General Considerations

a) Continuation therapy, typically consisting of psychotropic medication or ECT, is indicated for virtually all patients. The rationale behind decisions not to recommend continuation therapy should documented.

b) Continuation therapy should begin as soon as possible after termination of the ECT course, except when presence of adverse ECT effects, e.g., delirium, necessitates a delay.

c) Unless countervened by adverse effects, continuation therapy should be maintained for at least 12 months. Patients with a high risk of recurrence or residual symptomatology will generally require longer-term maintenance therapy.

d) The aim of maintenance therapy is to prevent recurrence of new episodes of the index disorder. It is typically defined as treatment continuing longer than 12 months following completion of the most recent ECT course. Maintenance therapy is indicated when therapeutic response has been incomplete, when a recurrence of clinical symptoms or signs has occurred, or where a history of early relapse is present.

13.2. Continuation/Maintenance Pharmacotherapy

The choice of agent should be determined by the type of underlying illness, a consideration of adverse effects, and response history. In this regard, when clinically feasible, practitioners should consider a class of pharmacologic agents for which the patient did not manifest resistance during the treatment of the acute episode.

13.3. Continuation/Maintenance ECT

13.3.1. General

a) Continuation/Maintenance ECT should be available in programs administering ECT.

b) Continuation/maintenance ECT may be given on either an inpatient or outpatient basis. In the latter case, the recommendations presented in Section 11.1 apply.

13.3.2. Indications for Continuation ECT

a) history of recurring episodic illness which has been responsive to ECT; and

b) either 1) pharmacotherapy alone has not proved effective in preventing relapse or cannot be safely administered for such a purpose; or 2) patient preference; and

c) the patient is agreeable to receive continuation ECT, and is capable, with the assistance of others, of complying with the treatment plan.

13.3.3. Delivery of Treatments

a) Various formats exist for delivering continuation ECT. The timing of treatments should be individualized for each patient, and should be adjusted as necessary with consideration of both beneficial and adverse effects.

b) The duration of continuation ECT should be guided by the factors described in 13.1(b) and 13.1(c).

13.3.4. Maintenance ECT

a) Maintenance ECT is indicated when a need for maintenance treatment (Section 1-3.1(d)) exists in patients already receiving continuation ECT (Section 13.3.2).

b) Maintenance ECT treatments should be administered at the minimum frequency compatible with sustained remission.

c) The continued need for maintenance ECT should be reassessed at least every three months. This assessment should include consideration of both beneficial and adverse effects.

13.3.5. Pre-ECT Evaluation for Continuation/Maintenance ECT

Each facility using continuation/maintenance ECT should devise procedures for pre-ECT evaluation in such cases. The following recommendations are suggested, with the understanding that additions to or increased frequency of evaluative procedures should be included whenever clinically indicated.

a) Prior to each treatment:

1) interval psychiatric evaluation (this evaluation may be done monthly if treatments are at an interval of 2 weeks or less AND the patient has been clinically stable for at least 1 month)

2) interval medical history and vital signs (this exam may be done by the ECT psychiatrist or anesthetist at the time of the treatment session), with additional examination as clinically indicated

b) Updating of overall clinical treatment plan at least every three months.

c) Assessment of cognitive function (see Section 12.2.1) at least every three treatments.

d) At least every six months:

1) consent for ECT (see Chapter 8 )

anesthesia preoperative examination

e) Laboratory tests (see Chapter 6) at least yearly.

13.4 Continuation/Maintenance Psychotherapy

Psychotherapy, whether on an individual, group, or family basis, represents a useful component of the clinical management plan for some patients following an index ECT course.

APPENDIX B

Sample ECT Consent Documents

1. Consent Form : Acute Phase
2. Consent Form: Continuation/Maintenance ECT
3. Patient Information Sheet

Electroconvulsive Therapy (ECT) Consent Form:
Acute Phase

Name of Patient:__________________

My doctor, ___________________________, has recommended that I receive treatment with electroconvulsive therapy (ECT). This treatment, including the risks and benefits that I may experience, has been fully described to me. I give my consent to be treated with ECT.

Whether ECT or an alternative treatment, like medication or psychotherapy, is most appropriate for me depends on my prior experience with these treatments, the features of my illness, and other considerations. Why ECT has been recommended for me has been explained.

ECT involves a series of treatments, which may be given on an inpatient or outpatient basis. To receive each treatment I will come to a specially equipped area in this facility. The treatments are usually given in the morning. Because the treatments involve general anesthesia, I will have had nothing to eat or drink for several hours before each treatment. Before the treatment, a small needle will be placed in my vein so that I can be given medications. An anesthetic medication will be injected that will quickly put me to sleep. I will then be given another medication that will relax my muscles. Because I will be asleep, I will not experience pain or discomfort or remember the procedure. Other medications may also be given depending on my needs.

To prepare for the treatment, monitoring sensors will be placed on my head and body. Blood pressure cuffs will be placed on an arm and leg. This monitoring involves no pain or discomfort. After I am asleep, a carefully controlled amount of electricity will be passed between two electrodes that have been placed on my head.

I may receive bilateral ECT or unilateral ECT. In bilateral ECT, one electrode is placed on the left side of the head, the other on the right side. In unilateral ECT, both electrodes are placed on the same side of the head, usually the right side. Right unilateral ECT (electrodes on the right side) is likely to produce less memory difficulty than bilateral ECT. However, for some patients bilateral ECT may be a more effective treatment. My doctor will carefully consider the choice of unilateral or bilateral ECT.

The electrical current produces a seizure in the brain. The amount of electricity used to produce the seizure will be adjusted to my individual needs, based on the judgment of the ECT physician. The medication used to relax my muscles will greatly soften the contractions in my body that would ordinarily accompany the seizure. I will be given oxygen to breathe. The seizure will last for approximately one minute. During the procedure, my heart, blood pressure, and brain waves will be monitored. Within a few minutes, the anesthetic medications will wear off and I will awaken. I will then be observed until it is time to leave the ECT area.

The number of treatments that I will receive cannot be known ahead of time. A typical course of ECT is six to twelve treatments, but some patients may need fewer and some may need more. Treatments are usually given three times a week, but the frequency of treatment may also vary depending on my needs.

ECT is expected to improve my illness. However, I understand that I may recover completely, partially, or not at all. After ECT, my symptoms may return. How long I will remain well cannot be known ahead of time. To make the return of symptoms less likely after ECT, I will need additional treatment with medication, psychotherapy, and/or ECT. The treatment I will receive to prevent the return of symptoms will be discussed with me.

Like other medical treatments, ECT has risks and side effects. To reduce the risk of complications, I will receive a medical evaluation before starting ECT. The medications I have been taking may be adjusted. However, in spite of precautions, it is possible that I will experience a medical complication. As with any procedure using general anesthesia, there is a remote possibility of death from ECT. The risk of death from ECT is very low, about one in 10,000 patients. This rate may be higher in patients with severe medical conditions.

ECT very rarely results in serious medical complications, such as heart attack, stroke, respiratory difficulty, or continuous seizure. More often, ECT results in irregularities in heart rate and rhythm. These irregularities are usually mild and short lasting, but in some instances can be life threatening. With modern ECT technique, dental complications are infrequent and bone fractures or dislocations are very rare. If serious side effects occur, the necessary medical care will be provided.

The minor side effects that are frequent include headache, muscle soreness, and nausea. These side effects usually respond to simple treatment.

When I awaken after each treatment, I may be confused. This confusion usually goes away within an hour.

I understand that memory loss is a common side effect of ECT. The memory loss with ECT has a characteristic pattern, including problems remembering past events and new information. The degree of memory problems is often related to the number and type of treatments given. A smaller number of treatments is likely to produce less memory difficulty than a larger number. Shortly following a treatment, the problems with memory are greatest. As time from treatment increases, memory improves.

I may experience difficulties remembering events that happened before and while I received ECT. The spottiness in my memory for past events may extend back to several months before I received ECT, and, less commonly, for longer periods of time, sometimes several years or more. While many of these memories should return during the first few months following my ECT course, I may be left with some permanent gaps in memory.

For a short period following ECT, I may also experience difficulty in remembering new information. This difficulty in forming new memories should be temporary and typically disappears within several weeks following the ECT course.

The majority of patients state that the benefits of ECT outweigh the problems with memory. Furthermore, most patients report that their memory is actually improved after ECT. Nonetheless, a minority of patients report problems in memory that remain for months or even years. The reasons for these reported long-lasting impairments are not fully understood. As with any medical treatment, people who receive ECT differ considerably in the extent to which they experience side effects.

Because of the possible problems with confusion and memory, I should not make any important personal or business decisions during, or immediately following, the ECT course. During and shortly after the ECT course, and until discussed with my doctor, I should refrain from driving, transacting business, or other activities for which memory difficulties may be troublesome.

The conduct of ECT at this facility is under the direction of Dr. ____________________

I may contact him/her at ___________ if I have further questions.

I am free to ask my doctor or members of the ECT treatment team questions about ECT at this time or at any time during or following, the ECT course. My decision to agree to ECT is being made voluntarily, and I may withdraw my consent for further treatment at any time.

I have been given a copy of this consent form to keep.

Date                Signature

_________     _________________________

Person Obtaining Consent:

Name              Signature

_________     _________________________

Electroconvulsive Therapy (ECT) Consent Form:
Continuation/Maintenance Treatment

Name of Patient:

My doctor, ____________________________ has recommended that I receive continuation or maintenance treatment with electroconvulsive therapy (ECT). This treatment, including, the risks and benefits that I may experience, has been fully described to me. I give my consent to be treated with continuation ECT.

I will receive ECT to prevent relapse of my illness. Whether ECT or an alternative treatment, like medication or psychotherapy, is most appropriate for me at this time depends on my prior experience with these treatments in preventing, the return of symptoms, the features of my illness, and other considerations. Why continuation/maintenance ECT has been recommended for me has been explained.

Continuation/maintenance ECT involves a series of treatments with each usually separated in time by one or more weeks. Continuation /maintenance ECT is usually given for a period of several months or longer. These treatments may be given on an inpatient or outpatient basis.

To receive each continuation/maintenance treatment I will come to a specially equipped area in this facility. The treatments are usually given in the morning. Because the treatments involve general anesthesia, I will have had nothing to eat or drink for several hours before each treatment. Before the treatment, a small needle will be placed in my vein so that I can be given medications. An anesthetic medication will be injected that will quickly put me to sleep. I will then be given another medication that will relax my muscles. Because I will be asleep, I will not experience pain or discomfort or remember the procedure. Other medications may also be given depending on my needs.

To prepare for the treatment, monitoring sensors will be placed on my head and body. Blood pressure cuffs will be placed on an arm and leg. This monitoring involves no pain or discomfort. After I am asleep, a carefully controlled amount of electricity will be passed between two electrodes that have been placed on my head.

I may receive bilateral ECT or unilateral ECT. In bilateral ECT, one electrode is placed on the left side of the head, the other on the right side. In unilateral ECT, both electrodes are placed on the same side of the head, usually the right side. Right unilateral ECT (electrodes on the right side) is likely to produce less memory difficulty than bilateral ECT. However, for some patients bilateral ECT may be a more effective treatment. My doctor will carefully consider the choice of unilateral or bilateral ECT.

The electrical current produces a seizure in the brain. The amount of electricity used to produce the seizure will be adjusted to my individual needs, based on the judgment of the ECT physician. The medication used to relax my muscles will greatly soften the contractions in my body that would ordinarily accompany the seizure. I will be given oxygen to breathe. The seizure will last for approximately one minute. During, the procedure, my heart, blood pressure, and brain waves will be monitored. Within a few minutes, the anesthetic medications will wear off and I will awaken. I will then be observed until it is time to leave the ECT area.

The number of continuation/maintenance treatments that I will receive will depend on my clinical course. Continuation ECT is usually given for at least six months. If it is felt that continuation ECT is helpful and should be used for a longer period (maintenance ECT), I will be asked to consent to the procedure again.

ECT is expected to prevent the return of my psychiatric condition. While for most patients ECT is effective in this way, I understand that this cannot be guaranteed. With continuation/maintenance ECT I may remain considerably improved or I may have a partial or complete return of psychiatric symptoms.

Like other medical treatments, ECT has risks and side effects. To reduce the risk of complications, I will receive a medical evaluation before starting ECT. The medications I have been taking may be adjusted. However, in spite of precautions, it is possible that I will experience a medical complication. As with any procedure using general anesthesia, there is a remote possibility of death from ECT. The risk of death from ECT is very low, about one in 10,000 patients. This rate may be higher in patients with severe medical conditions.

ECT very rarely results in serious medical complications, such as heart attack, stroke, respiratory difficulty, or continuous seizure. More often, ECT results in irregularities in heart rate and rhythm. These irregularities are usually mild and short lasting, but in some instances can be life threatening. With modem ECT technique, dental complications are infrequent and bone fractures or dislocations are very rare. If serious side effects occur, the necessary medical care will be provided.

The minor side effects that are frequent include headache, muscle soreness, and nausea. These side effects usually respond to simple treatment.

When I awaken after each treatment, I may be confused. This confusion usually goes away within an hour.

I understand that memory loss is a common side effect of ECT. The memory loss with ECT has a characteristic pattern, including problems remembering past events and new information ion. The degree of memory problems is often related to the number and type of treatments given. A smaller number of treatments is likely to produce less memory difficulty than a larger number. Shortly following a treatment, the problems with memory are greatest. As time from treatment increases, memory improves.

I may experience difficulties remembering events that happened before and while I received ECT. The spottiness in my memory for past events may extend back to several months before I received ECT, and, less commonly, for longer periods of time, sometimes several years or more. While many of these memories should return during the first few months following continuation ECT, I may be left with some permanent gaps in memory.

For a short period following each treatment, I may also experience difficulty in remembering new information. This difficulty in forming new memories should be temporary and will most likely disappear following completion of continuation/maintenance ECT.

The effects of continuation/maintenance ECT on memory are likely to be less pronounced than those during an acute ECT course. By spreading treatments out in time, with an interval of a week or more between treatments, there should be substantial recovery of memory between each treatment.

Because of the possible problems with confusion and memory, it is important that I not drive, or make any important personal or business decisions the day that I receive a continuation/maintenance treatment. Limitations on my activities may be longer depending on the side effects I experience following each treatment, and will be discussed with my doctor.

The conduct of ECT at this facility is under the direction of Dr. _________________

I may contact him/her at ___________if I have further questions.

I am free to ask my doctor or members of the ECT treatment team questions about ECT at this time or at any time during or following the ECT course. My decision to agree to continuation/maintenance ECT is being made voluntarily, and I may withdraw my consent for future treatment at any time.

I have been given a copy of this consent form to keep.

Date                Signature

_________     _________________________

Person Obtaining Consent:

Name              Signature

_________     _________________________

Sample Patient Information Booklet

Electroconvulsive Therapy

What is Electroconvulsive Therapy?

Electroconvulsive therapy (ECT or shock treatment) is an extremely safe and effective medical treatment for certain psychiatric disorders. With this treatment, a small amount of electricity is applied to the scalp and this produces a seizure in the brain. The procedure is painless because the patient is asleep, under general anesthesia.

Who is Treated with ECT?

ECT has been used for over 60 years. In the United States, about 100,000 individuals are estimated to receive ECT each year. ECT is most commonly given when patients have severe depressive illness, mania, or some forms of schizophrenia. Frequently, ECT is given when patients have not responded to other treatments, when other treatments appear to be less safe or difficult to tolerate, when patients have responded well to ECT in the past, or when psychiatric or medical considerations make it particularly important that patients recover quickly and fully.

Not all patients improve when treated with medications or psychotherapy (talk therapy). Indeed, when illnesses such as depression become particularly severe, it is doubtful that psychotherapy alone will be sufficient. For some patients, the medical risks of medications are greater than the medical risks of ECT. Typically, these are people with serious medical problems, such as some types of heart disease. When patients have life-threatening psychiatric problems, such as suicidal tendencies, ECT is also often recommended because it usually provides faster relief than medications. Overall, about 70 to 90% of the depressed patients treated with ECT show substantial improvement. This makes ECT the most effective of the antidepressant treatments.

Who Administers ECT?

A treatment team gives ECT. The team consists of a psychiatrist, an anesthesiologist, and nurses. The physicians responsible for administering ECT are experienced specialists. ECT is administered in a dedicated suite at the (name of facility) The suite contains a waiting, area, a treatment room, and a recovery room.

How is ECT Given?

Before ECT is administered, the patient’s medical condition is carefully assessed. This includes a complete medical history, physical examination, and medical tests, as needed. The treatments are usually given three times per week in the morning on Monday, Wednesday and Friday. Before each treatment, the patient should not eat or drink anything after midnight. Patients should also try to refrain from smoking during the morning prior to the treatment.

When the patient comes to the ECT treatment room, an intravenous line is started. Sensors for recording, EEG (electroencephalogram, a measure of brain activity) are placed on the head. Other sensors are placed on the chest for monitoring EKG (electrocardiogram). A cuff is wrapped around an arm for monitoring blood pressure. When everything is connected and in order, an anesthetic medication (methohexital) is injected through the intravenous line that will cause the patient to sleep for 5 to 10 minutes. Once the patient falls asleep, a muscle relaxant (succinylcholine) is injected. This prevents movement, and during the seizure there are only minimal contractions of the muscles.

When the patient is completely asleep and the muscles are well relaxed, the treatment is given. A brief electrical charge is applied to electrodes on the scalp. This stimulates the brain and produces the seizure that lasts for about a minute. Throughout the procedure, the patient receives oxygen through a mask. This continues until the patient resumes breathing on his or her own. When the treatment is completed, the patient is taken to a recovery area for monitoring by trained staff. Usually within 30 to 60 minutes, the patient can leave the recovery area.

How Many Treatments are Needed?

ECT is given as a course of treatments. The total number needed to successfully treat psychiatric disturbance varies from patient to patient. For depression, the typical range is from 6 to 12 treatments, but some patients may require fewer and some patients may require more treatments.

Is ECT Curative?

ECT is extremely effective in providing relief from psychiatric symptoms. However, permanent cures for psychiatric illness are rare, regardless of the treatment given. To prevent relapse following ECT, most patients require further treatment with medications or with ECT. If ECT is used to protect against relapse, it is usually administered to outpatients on a weekly to monthly basis.

How Safe is ECT?

It is estimated that death associated with ECT occurs in one of 10,000 patients. This rate may be higher in patients with severe medical conditions. ECT appears to have less risk of death or serious medical complications than a number of the medications used to treat psychiatric conditions. Because of this strong safety record, ECT is often recommended for patients with serious medical conditions. With modem anesthesia, fractures and dental complications are very rare.

What are the Common Side Effects of ECT?

The patient will experience some confusion on awakening following, the treatment. This is partly due to the anesthesia and partly due to the treatment. The confusion typically clears within an hour. Some patients have headaches following the treatment. This is usually relieved by Tylenol or aspirin. Other side effects, such as nausea, last for a few hours at most and are relatively uncommon. In patients with heart disease, there is an increased risk of cardiac complications. Cardiac monitoring and other precautions, including the use of additional medications if required help to ensure a safe treatment.

The side effect of ECT that has received the most attention is memory loss. ECT results in two types of memory loss. The first involves rapid forgetting of new information. For example, shortly following the treatment, patients may have difficulty remembering conversations or things they have recently read. This type of memory loss is short-lived and has not been shown to persist for more than a few weeks following the completion of ECT. The second type of memory loss concerns events from the past. Some patients will have gaps in their memory for events that occurred in the weeks to months and, less commonly, years prior to the treatment course. This memory loss also reverses following the completion of ECT. However, in some patients there may be permanent gaps in memory for events that occurred close in time to the treatment. However, like with any treatment, patients differ in the extent to which they experience side effects, and more extensive memory loss has been reported by a minority of individuals. It is known that the effects on memory are not necessary to obtain the benefits of ECT.

Many psychiatric illnesses result in impairments of attention and concentration. Consequently, when the psychiatric disturbance improves following ECT, there is often improvement in these aspects of thinking. Shortly following, ECT, most patients show improved scores on tests of intelligence, attention, and learning.

Does ECT Cause Brain Damage?

The scientific evidence strongly speaks against this possibility. Careful studies in animals have shown no evidence of brain damage from brief seizures, like those given with ECT. In the adult, seizures must be sustained for hours before brain damage can occur, yet the ECT seizure lasts only for about a minute. Brain imaging studies following ECT have shown no changes in the structure or composition of the brain. The amount of electricity used in ECT is so small that it cannot cause electrical injury.

How Does ECT Work?

Like many other treatments in medicine, the exact process that underlies the effectiveness of ECT is uncertain. It is known that the benefits of ECT depend on producing a seizure in the brain and on technical factors in how the seizure is produced. Biological changes that result from the seizure are critical to effectiveness. Most investigators believe that specific changes in brain chemistry produced by ECT are the key to restoring normal function.

Considerable research is being conducted to isolate the critical biochemical processes.

Is ECT Frightening?

ECT has often been portrayed in the movies and TV as a painful procedure, used to control or punish patients. These portrayals have no resemblance to modem ECT. One survey found that following ECT most patients reported that it was no worse than going to the dentist, and many found ECT less stressful. Other research has shown that that the vast majority of patients report that their memory is improved following ECT and that if needed, they would receive ECT again.

ECT is an extremely effective form of treatment. It is often safer and more effective than medications or no treatment at all. If you have any questions about ECT, please discuss them with your physician. You may also wish to read one of the following books. Both books were written by psychologists who were against people having ECT until they each had a severe depression and needed the treatment. Drs. Endler and Manning describe their illness, their experience in treatment with medication and psychotherapy, and their experience with ECT.

HOLIDAY OF DARKNESS
by Norman S. Endler
Wall & Thompson, Toronto
1990

UNDERCURRENTS: A THERAPIST’S
RECKONING WITH DEPRESSION
by Martha Manning
Harper, San Francisco
1995

Letter to Surgeon General from Support Coalition International re: Electroconvulsive Therapy Report

November 2, 1999

Dear Richard Nakamura, PhD and Matt Rudorfer, M.D.:

My understanding is that you both met recently with individuals concerned about your stubborn decision to reassure the nation that electroshock has been approved by the U.S. government for “safety and efficacy,” despite your having absolutely NO scientific proof or documentation for that claim; your apparent intent is that your reassurance will be sent to millions of people, via a prestigious U.S. Surgeon General’s report.

Where is your proof? Show us.

Since you have met with others, we would like to request a personal meeting with you about this matter as soon as possible, with representatives of our group, Support Coalition International. As Center for Mental Health Services can tell you, we have been one of the main groups working on human rights and electroshock this decade, and we represent 75 grassroots groups.

We are led by individuals who have experienced human rights violations in the “mental health system,” including electroshock.

This e-mail with touch on just a few matters, because of the urgency of the situation.

The Food & Drug Administration — the main government agency legally mandated to do so — has *never* completed an examination of the electroshock device for safety and efficacy.

Never.

Where is your proof? Show us.

Despite the fact that the electroshock device impacts the most complex organ known — the brain — the FDA has illegally refused to complete examinations of the device for safety and efficacy.

It’s impossible for you to deny this.

So how can you give a blanket endorsement of “safety and efficacy” of electroshock?

Let me give just a few examples in this note, there are plenty more.

None of the shock devices are regulated, and the amount of electrical energy they deliver (as measured in “joules”), varies wildly from machine to machine. Today, a typical shock device can deliver far more “joules” than previous machines.

Yet, the FDA has never looked into safety and efficacy.

So where is your “scientific” documentation for safety and efficacy of the electroshock device?

Where is your proof? Show us.

This is not a parlor room debate: Your endorsement could effect the brains and future and livelihood of countless Americans.

As more and more is learned about shock and the brain, you may be remembered the way 1950′s doctors who blithely endorsed cigarettes are remembered today. History is not on your side.

Let me speak for a moment about the big picture: I have a personal interest in the history of science, and I’ve been examining the record of this millennium. Much of what we mistakenly call “science” is actually about POWER. So it is no surprise that a device that can be so intrusive into our very beings like electroshock, and that typically impacts one of the most de-valued members of our society (depressed elder women), and is promoted by one of the most powerful and unchecked professions in the U.S…. it is no surprise that there is a terrible and unscientific bias against evaluating this device for safety and efficacy.

What is surprising is that you would ignore the scientific and undeniable truth that this device is one of the few modern devices that has NEVER been investigated for safety and efficacy. NEVER.

Where is your proof? Show us.

I will give you just one example why your simplistic reassurance about safety and efficacy is unscientific and false.

Nine years ago, the American Psychiatric Association issued a guideline book about electroshock (though they were careful to put in a disclaimer that the book didn’t necessarily reflect their official position). In that APA guide book on shock, there’s sample informed consent material. And in that informed consent material, there is a reassurance that the risk of severe long-term memory problems is about 1 in 200 — only .5 percent.

We were immediately suspicious, and for years we investigated that “1 in 200″ number — which is used widely, where the rubber hits the road, such as here in Sacred Heart in Eugene and in the State of Oregon’s state mental health system’s informed consent materials.

Well, the Washington Post did a large piece about electroshock, and we convinced them to investigate this number. They did investigate. The _Post_ found that the committee that wrote the guidelines consisted mainly of professionals with direct financial interest in the manufacturing of the devices. So the _Post_ asked them about the origins of that 1 in 200 number. One of the committee members explained that it was an “impressionistic” number NOT BASED ON ANY DATA AT ALL.

We wrote to the American Psychiatric Association board of directors. Now, the _Psychiatric News_ 7/18/99 (the APA’s newspaper) there’s an article about the brand new shock guidelines to be published soon by the American Psychiatric Association. And in that article it quotes Richard Weiner, ME, PhD about the model informed consent material in the new guideline: “There is also a more explicit statement in the sample consent form on the possibility of significant memory loss following ECT.”

We’ve seen an advanced draft, and apparently they’ve quietly taken out that “1 in 200″ reassurance. So for nearly a decade, thousands upon thousands of Americans have been reassured with this false ratio, and the federal government has done absolutely NOTHING — no investigation of safety, no investigation of informed consent. We wrote the FDA many times about this problem, and they did nothing.

But perhaps due to our pressure, or because of the _Washington Post_ article, or their own conscience, the APA and Weiner have taken out that totally fraudulent and unscientific “1 in 200″ number in their next proposed informed consent.

And meanwhile, what about YOU? You are going in the other direction. While the APA is covering its tracks after falsely reassuring the public, you are marching onward toward reassurance… based on what? Where is your scientific investigation of safety and efficacy, and of the risk of persistent memory loss of pre-hospitalization memories, for example?

For example, why have you not looked into the information from Texas, which has officially gathered information about deaths following electroshock, and has found that the death rate is far, far higher than what psychiatry has been claiming?

If you reassure the American public that shock has been officially investigated by the federal government for safety and efficacy you will be lying.

Where is your proof? Show us.

I’ve studied comparative religions, and there’s one “sin” that they all agree upon: lying. It is wrong. And if that doesn’t reach you, then just ask yourself about the SCIENCE.

To recap, the APA is getting MORE careful in this past decade, so they will pull a false reassurance about low risk of memory problems… and they publicly state they will be “more explicit” about “possibility of significant memory loss.” And you? Why are you going in the opposite direction, where even the shock industry fears to tread? Why are you giving this unregulated device a false stamp of approval, paid for by the taxpayers?

Your actions are fraudulent, and would lead to lack of informed consent for electroshock for thousands upon thousands of Americans, with no scientific validity for your statement. That is immoral, that is criminal.

Imagine this is the 1950′s, and you are about to give the stamp of approval for the “safety and efficacy” of cigarettes… how many years will it take to change that, to deal with the damage? How many minds and brains of Americans will be harmed, under FALSE reassurance? The use of fraud robs people of their FREEDOM to choose. Where is your moral courage?

Isn’t this supposed to be the land of the free and the brave? Was that a lie?

Where is your proof? Show us.

We have a right to know, because our members’ horrible experiences are the RESULTS of misguided stubborn and unscientific statements by people such as yourself.

I will copy this to two individuals in the Clinton administration who have told us they care about our voice being heard: Paolo del Vecchio and Jonathan M. Young. This is the time for them to prove what they have told us.

Scottish ECT Audit, letter from Alex Doherty

email: Alexdoherty@btinternet.com
27 January 2002
Richard Norris
SAMH
GLASGOW

Dear Richard
SCOTTISH ECT AUDIT
We wrote to you recently about the above audit. As you know, we decided to look further into the facts and figures published by Freeman & Company. We now wish to comment in detail to their publication, ECT In Scotland.

The articles quoted. Table 21 on page 20
Reid 98.) Reid gives the figure of 0.31% for deaths within two weeks. We think Freeman has taken out the 2 suicides and I accident to reach his figure of 0.2%.

Murphy 88. ) Murphy looked at 4 year ( not 1 week ) mortality in elderly people, and he found an increased mortality in depressed people, even when physical health was controlled ( but the increased mortality was not necessarily caused by depression and some of Murphy’s patients may have had ECT. The Audit authors seem to be confusing percentage points with percentages, but that works against the point they are trying to make.

Prudic 99. ) Sackeim & Prudic did not claim that ECT reduces the suicide rate. “The comparisons of long-term outcome in patients hospitalised in pre-ECT & ECT eras found that the introduction of ECT had little impact on suicide rates…..The findings from the quasi-controlled studies, particularly the more recent investigations, show little uniform evidence for a positive effect on long term suicide rates”….

Lee 96. ) Lee is referring to 0.3 – 0.4 medical complications not specifically anaesthetic. (He was quoting earlier studies so we don’t know if the complications were enough to stop the course.

Peet 94. ) Should be �less than 1% – 11%’ not 1% (0.52% of unipolar patients on tricyclics to 11.2% of bipolar on tricyclics). Again, the authors don’t say if the mania was enough to stop the course.

Page 19
Inskip.) 6% not 7%.

Thorogood.) The 17X figure is for psychotropic drugs (major and minor tranquillisers, tricyclics, thioxanthene, barbiturates) not specifically tricyclics.

To conclude this section of our observations, We think it would be a reasonable assumption to say and make. That most patients undergoing ECT are also taking psychotropic medication. We find it difficult to discern however Dr. Freeman’s use of comparisons regarding drugs and ECT. Which begs the questions. Were none of the patients treated with ECT in the audit taking medication ? And if so. Why was no information given on drugs within the audit? This study comparing the safety of ECT against tricyclic medication is therefore flawed.

Moving on to the adverse events quoted in the audit. We think this section of the findings are the main reason why no press release accompanied its publication. To say that ECT is a safe and effective treatment based on these figures, is disgraceful and misleading.

Phase 2 735 courses analysed. 1 in 24.5 courses not completed.
Patient unwilling ………………………….15 = 1 in 49
Medical related/unrelated/manic ……….. 14= 1 in 53
Suicide………………………………………1= 1 in 735
Phase 3 579 courses
1 in 10 not completed
Unwilling…………………………………..18 = 1 in 32
Medical……………………………………37 = 1 in 16
Death………………………………………2 = 2 in 579
Crime (murder)……………………………1= 1 in 579
Phase 2+3 combined 735 + 579 = 1314 courses
Unwilling ………………………………….33 = 2.5% = 1 in 40
Medical……………………………………51 = 3.9% = 1 in 26
Death (inc. suicide)……………………….3 = 0.2% = 1 in 438
Crime 1

Total 88 = 6.7% = 1 in 15 not completed

We would welcome any comments SAMH may have on our analysis of the audit findings. Thanks for pointing me in the right direction to obtain the Milan report. There’s a lot of good stuff in there, although I’m unhappy with some of their recommendations. E.g.: Psychosurgery and certain aspects of ECT. I am delighted that ECT, if Milan’s recommendations are taken up, will not be given to anyone capable of refusing it. In theory this would have prevented Joseph getting it. In theory….. Speak with you soon

Alex Doherty
cc Sue Kemsley

CMHS – ELECTROCONVULSIVE THERAPY BACKGROUND PAPER

ELECTROCONVULSIVE THERAPY BACKGROUND PAPER

By RESEARCH-ABLE, INC.

Prepared for the U.S. Department of Health and Human Services Substance Abuse and Mental Health Services Administration Center for Mental Health Services

March 1998
Prepared pursuant to CMHS Contract No. 0353-95-0004
RESEARCH-ABLE, INC., 501 Niblick Drive, S.E., Vienna Virginia 22180

TABLE OF CONTENTS

PURPOSE

INTRODUCTION

I. HISTORY

II. ECT AS A METHOD OF TREATMENT
* Administration of ECT
* Risks
* Theories Regarding Mechanism of Action
* Conditions for Which ECT Is Used
* Importance of Patient Consent to Treatment
III. CONSUMER AND PUBLIC ATTITUDES REGARDING ECT
* Introduction
* Basis of the Opposition to ECT
* Questions Regarding Persons Giving Voluntary Informed Consent
* Opponents of ECT
* Proponents of ECT and Informed Consent
IV. LEGAL PERSPECTIVES AND STATE REGULATION

V. RESEARCH PRIORITIES IDENTIFIED BY 1985 NIMH CONSENSUS DEVELOPMENT CONFERENCE ON ECT

SUMMARY

APPENDIX A – Interviews with Representatives of Organizations

PURPOSE

The Center for Mental Health Services (CMHS) periodically issues reports on topics of concern to the mental health field and to the American public. Part of the CMHS’s responsibility is to develop and disseminate information on the delivery of services to persons with mental illness and their families.

This report on electroconvulsive therapy (ECT) summarizes the following information:
1) the current state of knowledge regarding this treatment;
2) consumer and public views;
3) relevant laws and regulations; and
4) priority research tasks.

INTRODUCTION

ECT, a treatment for serious mental illness, involves the production of a generalized seizure through application of a brief electrical stimulus to the brain. Since ECT was first used in Italy more than 50 years ago, the procedures associated with ECT have been improved. Better methods have been developed in regard to anesthesia, the delivery of electrical current, and patient preparation and consent.

Broad agreement exists within the medical-psychiatric community about the effectiveness and safety of ECT for the treatment of people with certain mental illnesses. However, some of those to whom ECT has been administered, are greatly concerned about its possible misuse and abuse. They are also concerned about what they perceive to be a failure to protect the rights of patients. Their concern may be heightened both because treatment side effects (e.g., post-treatment confusion and memory loss) are not uncommon, and because scientists have yet to clarify precisely how ECT works to relieve symptoms. ECT is used primarily for people with severe depression. (1) The treatment is usually provided in the psychiatric units of general hospitals and in private psychiatric hospitals. According to a 1995 report, (2) per capita utilization rates of ECT vary widely across the United States, and an estimated 100,000 patients received ECT during 1988-1989.

I. HISTORY

In 1938, Ugo Cerletti, an Italian neuropsychiatrist, applied electric shock to the brain of a person with a serious psychiatric illness. According to reports, the man’s condition improved dramatically, and within 10 years, this treatment was employed widely in the United States.(3) In the 1940′s and 1950′s, ECT was used mainly for persons with severe mental illness residing in large mental institutions (mainly State hospitals). The 1985 Report of the National Institute of Mental Health (NIMH) Consensus Development Conference on ECT (4) described these early efforts:

“ECT was used for a variety of disorders, frequently in high doses and for long periods. Many of these efforts proved ineffective, and some even harmful. Moreover, the use of ECT as a means of managing unruly patients, for whom other treatments were not then available, contributed to a perception of ECT as an instrument of behavioral control for patients in institutions for chronically mentally ill individuals.”

In 1975, the blockbuster movie, One Flew Over the Cuckoo’s Nest, based on the 1962 novel by Ken Kesey, dramatically reinforced fears regarding ECT, at least for the movie-going public. More recently, at legislative hearings in Texas, (5) opponents of ECT buttressed their concerns about its safety and effectiveness with testimony about the results of Internet surveys. (6)

In the early years, many fractures and even a number of deaths were associated with the use of ECT. (7) Over the years, however, ECT has changed. The technology associated with ECT has been improved, virtually eliminating previous risks. (8) Safer methods of administration have been developed, including the use of medications, muscle relaxants, and an adequate supply of oxygen throughout treatment.

It is believed that the largest category of people receiving ECT are elderly, depressed women who are inpatients in general or private psychiatric hospitals. (9) Most States do not require physicians to report ECT use; therefore, annual estimates of the number of patients receiving this treatment are speculative. What scientific data do exist suggest a great deal of regional variation in its use — more so than for most other medical and surgical procedures. (10)

The absolute number of individuals receiving ECT appears to have decreased. Public complaints, coupled with litigation, have caused many public institutions to become increasingly uneasy about its use, and State regulation has served to reduce its administration in public hospitals. Moreover, the revolution in psychopharmacology since the 1960′s, has played a role in lowering the number of patients receiving ECT. Today, the procedure is most often administered only after other treatment alternatives have been tried and found to be unsuccessful.

While patient concern about ECT has a long history, the growing prominence of the consumer rights movement has, in recent years, brought the issue to increasing public attention. The concept of informed consent for treatment is becoming more widely understood and accepted by patients and their families. Opponents who argue for a total legislative ban, assert that ECT causes long-term memory loss and is frequently administered without having been explained adequately. Such arguments have led many States to require patients to give consent before ECT can be administered (See Section IV below).

II. ECT AS A METHOD OF TREATMENT

Administration of ECT

ECT involves the use of controlled electrical currents of one to two seconds in duration that induce a 30-second seizure. Generally, the procedure involves attaching two electrodes to the scalp, one on each side of the head, although physicians sometime place the electrodes on only one side of the head. Often, two or three treatments are given weekly for several weeks. In its early years, ECT was administered to patients without prior medication. Today, however, anesthesia, muscle relaxants, and electroencephalographic (EEG) monitoring during and following treatment, enable the physician to closely check patient reactions. Thus, involuntary movement from ECT-induced seizure normally consists of a slight movement of the fingers and toes. (11)

Risks

Some patients who have received ECT report long-term side effects from the treatment. Memory deficits have been reported even three years post-treatment, although most seem to occur around the period immediately prior to and following the procedure. While not minimizing the significance of adverse side effects, most members of the medical community maintain that the duration of such side effects is relatively brief:

“It is.. .well established that ECT produces memory deficits. Deficits in memory function, which have been demonstrated objectively and repeatedly, persist after the termination of a normal course of ECT. Severity of the deficit is related to the number of treatments, type of electrode placement, and nature of the electric stimulus… The ability to learn and retain new information is adversely affected for a time following the administration of ECT; several weeks after its termination, however, this ability typically returns to normal.” (12)

Theories Regarding Mechanism of Action

While many theories have sought to explain the therapeutic effects of ECT, a determination of the precise mechanism of action awaits further research. (13) The medical community generally believes that something associated with the seizure itself, rather than a psychological factor such as patient expectation, causes neurophysiological and biochemical changes in the brain that account for the decrease or remission of symptoms. Permanent changes in brain structures have not been found in either animal studies or in autopsies performed on the brains of persons who had ECT at some time in their lives. Furthermore, studies in which animals have been subjected to much stronger and more protracted electric shock than those used during ECT, have not detected structural or biochemical brain changes. (14)

Conditions for Which ECT Is Used

Because beneficial psychopharmacological drugs are easier to administer, less expensive, and not as controversial as ECT, such interventions are usually attempted prior to employing ECT. ECT is generally considered only for persons with severe or psychotic forms of affective disorders (depression or bipolar illness) who either have failed to respond to other therapies or are considered to be at imminent risk of suicide. Since an antidepressant may not become fully effective for several weeks after treatment begins, the rapidity of symptom relief associated with ECT may make it the treatment of choice for people who cannot safely wait for alternative treatments (such as people who are suicidal). (15) ECT can make the patient accessible to the efficacious effects of medications and psychotherapy. (16) Clinicians also report that ECT can reduce the duration of episodes of mania and major depression, (17) and if used promptly, may help to shorten hospital stays of people with recurrent major depression. (18)

The Agency for Health Care Policy and Research, in a recent clinical practice guideline, (19) suggests ECT is appropriately used for selected patients with serious depressive disorders.

“It is a first-line option for patients suffering from severe or psychotic forms of major depressive disorder, whose symptoms are intense, prolonged, and associated with neurovegetative symptoms and/or marked functional impairment, especially if these patients have failed to respond fully to several adequate trials of medication. Electroconvulsive therapy may also be considered for patients who do not respond to other therapies, those at imminent risk of suicide or complications, and those with medical conditions precluding the use of medications….”

“However, ECT should be considered cautiously and used only after consultation with a psychiatrist, because ECT:

* Has not been tested in milder forms of illness.
* Is costly when it entails hospitalization.
* Has specific and significant side effects (e.g., short-term retrograde and anterograde amnesia).
* Includes the risks of general anesthesia.
* Carries substantial social stigma.
* Can be contraindicated when certain other medical conditions are present.
* Usually requires prophylaxis with antidepressant medication, even if a complete, acute phase response to ECT is attained.”
No general agreement exists within the medical community regarding the utility of ECT in the treatment of schizophrenia. Although a number of clinical studies suggest ECT is effective in treating people with schizophrenia, (20) they are not definitive.

Further research is also needed to determine whether ECT reinforces the effects of neuroleptic drugs. Clinicians find most ECT patients benefit from the use of supportive drug and/or talk therapy once ECT has alleviated the worst depressive or other symptoms. Recent scientific reports suggest major mood disorders among pregnant women can safely be treated with ECT if appropriate steps are taken to decrease risks to both mother and child. (21,22)

Importance of Patient Consent to Treatment

In the wake of the ongoing controversy surrounding ECT, the medical community has become increasingly sensitive to the importance of obtaining informed voluntary consent from patients before initiating treatment. State laws and regulations, as well as professional guidelines, (23) spell out in detail, the nature of such consent. They suggest or require that the medical provider educate the patient and his/her family using written and audio-visual materials as well as verbal explanations, before the patient signs a consent form. (24) Required or suggested consent forms generally specify the following kinds of information:

1) the nature of the treatment;
2) the likely benefits and possible risks of treatment;
3) the number and frequency of treatments to be undertaken;
4) alternative remedies; and
5) stipulations that patients retain the right to withdraw consent at any time during the treatment process.

In the case of an individual whose cognitive functioning and/or judgment may be impaired by psychiatric illness, it may be difficult to be certain of fully informed voluntary consent (see the discussion of legal aspects in Section IV below).

The 1985 NIMH Consensus Development Conference on ECT (25) commented on the issue of informed and voluntary consent:

“When the physician has determined clinical indications justify the administration of ECT, the law requires, and medical ethics demand, the patient’s freedom to accept or refuse the treatment be fully honored. An ongoing consultative process should take place. In this process, the physician must make clear to the patient the nature of the options available and the fact the patient is entitled to choose among these options.”

III. CONSUMER AND PUBLIC ATTITUDES REGARDING ECT

Introduction

Douglas G. Cameron (26) of the World Association of Electroshock Survivors, addressing the Public Health Committee of the Texas House of Representatives in an April 1995 public hearing to consider a ban on ECT, captured the strong feelings of many ECT opponents with the following statement:

(ECT is) “An instrument which has injured and destroyed the lives of hundreds and thousands of people since its inception and continues to do so today.”

Despite support from Cameron and others, proposed legislation to outlaw ECT was not enacted by the Texas legislature.

Comments contained in a two part series in USA Today (27) typify how some of the popular press view ECT:

“After years of decline, shock therapy is making a dramatic and sometimes deadly comeback, practiced now mostly on depressed elderly women who are largely ignorant of shock’s true dangers and misled about shock’s real risks.”

A study (28) based on an Internet survey of ECT recipients choosing to respond, quotes some as saying:

“(ECT was) the worst thing that ever happened to me, and:

“Destroyed my family.”

Citizens of Berkeley, California, in a 1982 local referendum, voted to “outlaw” the use of ECT. However, 40 days later, the courts ruled the result of the referendum to be unconstitutional.

The views of ECT opponents are balanced by people such as talk show host Dick Cavett who found ECT “miraculous,” (29) and writer Martha Manning who felt as if she got 30 IQ points back once the depression lifted. However, she lost forever some memories before and during ECT. (30)

Although few studies of patient attitudes about ECT have been reported in the literature, a consistent finding among them has been the relationship between good ECT response and favorable attitudes. (31) In a controlled study, Pettinati and her colleagues reported that six months after ECT treatments, most of the patients studied said they would agree to ECT in the future if they were to become depressed again. (32)

Basis of the Opposition to ECT

When it comes to evoking strong feelings for and against a therapy, ECT may be unique among the broad range of current medical and psychiatric treatments. Dramatic impressions and portrayals of its horrors are juxtaposed against the rapid relief and remission of symptoms it often provides. These antithetical pictures combine to keep the controversy raging. The ways in which ECT was used and administered in the past are probably major factors in the continuing dispute. Reports of serious injury such as fractures and/or death resulting from the administration of ECT are now extremely rare. (33) However, the occurrence of these adverse effects in the past continues to promote public concern. Memory loss is the most frequent complaint of ECT recipients. Although its proponents agree that patients may suffer short-term memory deficits (particularly for the periods immediately preceding and following treatment), substantial disagreement exists about the nature, magnitude, and duration of such deficits.

Questions Regarding Persons Giving Voluntary Informed Consent

The patients’ rights movement in the 1970′s and 1980′s heightened public and professional awareness regarding protection of the rights of persons with mental disorders, and the most emotionally-charged concerns about ECT probably center on questions of informed consent. (34) Are patients being fully informed and educated about the nature of ECT, the risks and benefits involved, and the availability of alternative, less intrusive treatments? Have they been told they can withdraw consent at any time during the treatment process? Is it clear that duress or inappropriate pressure has not been used to obtain agreement to the treatment? Is it clear that ECT is not being used to punish or control unruly patients?

Substantial ethical and legal issues may arise in regard to the involuntary administration of ECT. A report from the Wisconsin Coalition for Advocacy (35) indicates that such issues remain problematic in at least some hospitals in the State. The Coalition, which serves as the designated State Protection and Advocacy agency for persons with mental illness, responded to complaints regarding violation of the rights of patients on the psychiatry unit of a hospital in Madison. They reviewed treatment records and conducted in depth interviews that uncovered clear evidence of:

1) coercive practices to obtain patients’ consent and failure to honor patients’ refusal of treatment;
2) failure to provide sufficient information to patients for informed consent; and
3) consent to treatment by patients who were not mentally competent at the time they gave consent. (36)

Professional organizations such as the American Psychiatric Association have proposed guidelines (37) to educate patients and their families about informed patient consent to ECT, and a substantial number of States have passed laws regulating the practice of ECT. Still, there may remain instances in which physicians and facilities comply neither with the letter nor the spirit of the laws, nor with professional guidelines. When noncompliance occurs, it increases public distress about the use of ECT.

Opponents of ECT

While some opponents of ECT seek a total prohibition of its use, others focus on situations that may involve less than fully informed, fully voluntary consent.

David Oaks, editor of Dendron News for the Support Coalition International, emphasizes the importance of informed consent, “Our position on ECT as a treatment option is pro-choice � if the patient wants it, that’s his or her decision, but they must understand there is no proof of sustained efficacy.” (38)

Peter Breggin, a psychiatrist in private practice, strongly opposes the use of ECT. He characterizes the effects of ECT as “brain injury.” (39)

Leonard R. Frank, a writer often cited by ECT opponents, received combined insulin coma-electroshock in early 1962. He charges, “… ECT as routinely used today is as least as harmful overall as it was before changes in the technology of ECT administration were instituted.” (40)

Linda Andre, Director of the Consumer Rights Advocacy Group, the Committee for Truth in Psychiatry, states that all ECT involves involuntary treatment. Her organization, whose 500 members have experienced ECT, asserts that all patients receiving ECT are under some form of coercion. They maintain that ECT causes permanent head injury (brain damage). Recently, Andre stated, “Forced shock is the most profound violation of the human spirit imaginable. The use of force is a second injury superimposed upon the damage of the shock itself.” (41)

The National Association for Rights Protection and Advocacy is a non-profit organization composed of mental disability program administrators, paralegals, professionals, lay advocates, and consumers of mental health services. Its director, Bill Johnson, believes most members of the organization are opposed to the use of ECT and involuntary treatment. He stated, “Our members are against forced treatment laws. People should make their own choices, they have the right to choose. We try to empower people who have been labeled.” (42)

Proponents of ECT and Informed Consent

While no organizations have been established which are dedicated exclusively to retaining ECT as a treatment choice, representatives of the organizations identified below have expressed support for the position that ECT remain an option.

The National Depressive and Manic-Depressive Association (NDMDA), an organization of persons who have experienced depressive or manic-depressive illness and their families and friends, “strongly supports the appropriate use of electroconvulsive therapy.” (43)

The National Alliance for the Mentally Ill (NAMI), a grassroots organization composed of families and friends of people with mental illness and people recovering from mental illness, does not endorse any particular treatment or services. However, it recognizes the efficacy of ECT and of medications such as Clozopine and Prozac, and is opposed to measures intended to limit the availability of recognized effective treatments provided by appropriately trained and licensed practitioners. (44)

The National Mental Health Association, a non-profit organization of citizens concerned about the promotion of mental health and the prevention, treatment, and care of mental illness, supports the use of ECT in life-threatening situations (suicide), and for the treatment of severe affective disorders that do not respond to other treatments. (45)

The National Association of Protection and Advocacy Systems (NAPAS), the membership organization of State protection and advocacy agencies, has Federal authority and funds to investigate abuse and neglect of persons with mental illness. While NAPAS has not adopted a formal position on ECT, it strongly supports the importance of full and informed patient consent. (46)

IV. LEGAL PERSPECTIVES AND STATE REGULATION

Forty-three States have enacted legislation that in some way regulates the use of ECT. (47) Most of the State statutes directly address the administration of ECT; others regulate psychiatric treatment generally without specific reference to ECT. The most common approach, adopted in 20 States, requires either informed patient consent before the administration of ECT, or in the absence of informed consent, court determination of patient incompetency. There is substantial variation among requirements from one State to another.

Debate continues about the need to protect patients’ rights and the use of effective, albeit invasive, treatments such as ECT. (48) The argument is made that overly protective regulation can result in urgently needed treatment being substantially delayed. Most States regulate the administration of ECT, and require a judicial determination of incompetency before involuntary administration of ECT can begin. (49)

The issue of informed consent has been a significant focus of litigation, legislation, and regulation in recent years. Three key questions have been raised:

1) Does the individual have the capacity to form a reasonable judgment? (For example, to what extent is a person’s capacity to give informed consent to ECT treatment compromised, or even eliminated, by the condition for which the ECT is being recommended?);
2) Was consent obtained under circumstances free of coercion or threat? (For example, did the patient consent freely or did the patient feel threatened with court proceedings or isolation? Under what circumstances does the physician’s “opinion” unduly influence the informed voluntary consent of the patient?); and
3) Was sufficient information about the risk and availability of less invasive therapies provided to the patient as part of the education and consent process? (This last question is particularly complex involving, among other concerns, the uncertainty regarding the precise nature and duration of short and long term memory loss associated with ECT).

As with all medical treatments, administration of ECT is governed by State laws and regulations. Some States permit “substitute consent” by a spouse, a guardian, or an attorney-in-fact through a power of attorney. Other States take a more restrictive approach requiring that only the patient can give consent for treatment. (50)

Courts generally have ruled that a patient who has been involuntarily committed does not, per se, lack capacity to provide informed consent. Only under the most extreme conditions have the courts ruled that the right to refuse treatment is compromised by a depressive condition. The courts also generally do not permit a “substituted judgment” either by the court or a guardian. (51)

V. RESEARCH PRIORITIES IDENTIFIED BY 1985 NIMH CONSENSUS CONFERENCE

The National Institute of Mental Health Consensus Development Conference on Electroconvulsive Therapy, convened in June 1985, identified five priority research tasks : (52)

1) Initiation of a national survey to assemble basic facts about the manner and extent of ECT use, as well as studies of patient attitudes and responses to ECT;

2) Identification of the biological mechanisms underlying the therapeutic effects of ECT and the memory deficits that may be associated with the treatment;

3) Better delineation of the long-term effects of ECT on the course of affective illnesses and cognitive functions, including clarification of the duration of the therapeutic effectiveness of ECT;

4) Precise determination of the mode of electrode placement (unilateral vs. bilateral) and the stimulus parameters (form and intensity) that maximize efficacy and minimize cognitive impairment;

5) Identification of patient subgroups or types for whom ECT is particularly beneficial or toxic.

While many studies of ECT have been undertaken since the 1985 Consensus Development Conference on ECT, the issues regarding brain damage and memory loss have not yet been fully explored or understood. Consumer groups continue to express a strong desire for broader surveys of patients’ experiences with ECT because the few published studies to date have relied on small and/or self-selected samples.

SUMMARY

This report describes the current situation concerning ECT, and has attempted to capture the broad spectrum of opinions and views about its use.

APPENDIX A

INTERVIEWS WITH REPRESENTATIVES OF ORGANIZATIONS

In order to present a broad range of opinions about ECT, representatives of five citizen/consumer organizations with particular interest in ECT were interviewed. The interviewees were all asked the following questions:

� What position does your organization hold on the use of ECT?
� What do you think about involuntary administration of ECT?
� What is your position on the effectiveness of ECT?
� What do you feel about ECT as a treatment option?
� In general terms, how has your organization been involved with ECT since 1985?
� Can you tell me some of the experiences of your members?
� From the perspective of the consumer, what do you think are the overall benefits and risks of ECT?
� What would you say are the key issues for this report?
� Specifically, what should be done in terms of future research?
� What alternative treatments would you recommend?
� What do you see should be looked at in terms of the education for health care personnel involved with ECT? For the consumer? For the family of the consumer?

Response of Organizations

Support Coalition International (David Oaks).

“Our by-laws state that we are against coercion. Many of our members are outright opposed to the use of ECT. We are a coalition of 45 groups in six countries opposed to fraudulent informed consent… We feel there is a high rate of forced electroshock. The treatment is so intrusive. No means no. We are pro-choice, but insist on informed choice.”

“Doctors should offer empowering sustainable options such as peer groups, emphasizing real life needs of persons — housing, community and employment Our position on ECT is that if the patient wants it, it’s his or her decision, but they must understand there is no proof of sustained efficacy … (The treatment) is unproven, unsustained and unregulated by the government.”

“The Support Coalition was founded in 1990 … Forced ECT may involve less than five percent of all cases, but it is the litmus test to see if the Federal government is responsive to consumer empowerment. No consumer/survivor organization endorses forced ECT.”

“Our members tend to be folks with negative experiences. They have experienced devastating, poignant, persistent memory loss … Many members have personally experienced great problems … Our members have lost memories of weddings, the birth of children, the ability to play musical instruments, they can’t remember videos, vacations.”

“I have met some individuals who feel they have benefited from the treatment They may experience a temporary lift for a four-week period. This is not really recovery.”

“Forced ECT is the key issue. There have been more comments on this than on any other issue. It destroys trust and safety; it’s a violation, a profound violation to the core of one’s being. We are disappointed that CMHS (Center for Mental Health Services) has been slow to acknowledge and deal with this concern … Another important issue is fraudulent informed consent. There is much more of this than the American Psychiatric Association (APA) claims. Deaths also are much more frequent than the APA states.”

“Consumers and their families need to know the full range of hazards. People aren’t told memory problems can last as long as three years … Consumers should have a legal advocate present when they make decisions about treatment . . .They must have education on other alternatives and the right to refuse.”

National Association for Rights and Advocacy (NARPA) (Bill Johnson)

NARPA is a non-profit organization composed of mental disability program administrators, paralegals, professionals, lay advocates, and ECT survivors.

“We are opposed to involuntary treatment on moral and ethical grounds and are the only professional organization that takes this position … We oppose the resurgence of involuntary administration … The psychiatric profession usually minimizes the risks and overstates the successes of ECT.”

“If ECT is done against the will (of the patient), it is totally immoral. The procedure is a lot safer than it was, but nevertheless it remains violently intrusive.”

Respondent stated that NARPA has a large number of anti-shock activists among its members and most would seriously question the efficacy of shock treatments. He considers the following issues important: 1) An independent study of ECT, of its effectiveness and failures; 2) Ensuring consumers are fully informed about its pros and cons when they make treatment choices; and 3) Obtaining information about the profits hospitals and physicians make from ECT.

National Depressive and Manic-Depressive Association (NDMDA) (Donna DePaul- Kelly)

NDMDA consists of persons who have experienced depressive [unipolar] or manic- depressive [bipolar] illness and their families and friends. Excerpts from a NDMDA statement on ECT follow:

“Electroconvulsive therapy is a safe and effective treatment for certain patients with serious psychiatric illness. NDMDA strongly supports an individual’s right to receive any safe and effective treatment for psychiatric illnesses, including electroconvulsive therapy, and therefore strongly opposes any laws or regulations which interfere with patients’ access to competently administered electroconvulsive therapy (ECT).”

“Access to ECT, as well as all medical care, must be subject to complete, continuing informed consent. Consent must be obtained through a sincere effort, free from explicit or implicit coercion by the physician or the facility. The patient’s right to withdraw his/her consent at any time during the course of treatment must be protected. If the patient is incapable of consenting to treatment, the appropriate local legal procedures must be invoked.”

Respondent reported that she had heard from a lot of consumers that ECT works when other treatments do not and:

“ECT can get you to a place where other treatments will then begin to work. Consumers have told me that the memory lost from ECT isn’t nearly as much as the memory lost when they were severely depressed — sometimes they’ve lost weeks of their memory [to depression]. Most of the people we hear from have had a good experience with ECT.”

Respondent identified informed consent and overcoming the negative reputation of ECT as the two key issues.

National Association of Protection and Advocacy Systems (NAPAS) (Curt Decker)

NAPAS is an organization that has members in every State and territory that have Federal authority and resources to represent and investigate abuse and neglect in relation to mental illness.

NAPAS does not have a formal position on the use of ECT. However, the organization is leery about the administration of ECT and supports:

“… full and informed consent. We are very concerned about involuntary administration and believe it is a violation of persons’ rights. We are not medical people. We have heard from consumers that claim memory loss and we have worked with groups of consumers who have tried to ban ECT. But we have no position on this … I have heard from people who have had ECT and experienced severe memory loss. They are very angry and bitter. From the larger perspective, it plays into the issue of forced treatment … ECT is really a flash point for many consumers … One of the key issues is moving away from involuntary and forced treatment. Consumers need to be able to look at various treatment options so they can be more comfortable about ECT… There should be an opportunity to choose an ‘advance directive’ which is an agreement that a person makes in advance when they are more lucid and stable. This would make it easier for families and care givers because the consumer is actually making the decision that they okay certain treatments, in advance of when they are in an episode where they no longer can make a decision.”

Respondent indicated that research is needed on long term effects, positive as well as negative:

“Some people seem to respond only to ECT. Any treatments that are less daunting or undignified would be desirable … ECT is a flash point for consumers. Health care professionals want to use what is readily available and take the easy way out, particularly in difficult situations. They have to be more sensitive to the issues of rights and choices … They need to have better empathy with the feelings of families in this regard … From a research standpoint, it is important to know how ECT is being used, how often and why, and to make sure it is not being abused.”

National Alliance for the Mentally Ill (NAMI (Ron Honberg)

NAMI is a grassroots organization composed of families and friends of persons with mental illnesses and persons recovering from mental illnesses. Excerpts from a NAMI statement related to ECT follow:

“NAMI does not endorse any particular treatment or services. While not endorsing any particular form of treatment as a matter of policy, NAMI believes that access to treatments for individuals with mental illnesses that have been recognized as effective by the FDA and/or the NIMH should not be denied. NAMI therefore opposes measures that are intended to or actually do limit the availability and rights of individuals with mental illnesses to receive Clozaril (Clozopine), Fluoxetine (Prozac) and/or electroconvulsive therapy (ECT) from appropriately trained and licensed practitioners. These treatments are being singled out by NAMI because of ongoing efforts by various individuals and organizations to limit the rights of individuals with mental illnesses to receive them.”

“In accordance with scientific evidence, we feel ECT is an effective, sometimes lifesaving treatment. I know many that feel ECT has saved their lives. That is not to say it has not been inappropriately used, especially in the 1940′s and 1950′s. But the treatment should be available to people who do not respond to other treatments. We are opposed to efforts to ban ECT. This would be an inappropriate and grave injustice to those who really need it … Involuntary administration rarely happens. Given the controversial history and the dramatic nature of the treatment, most of those using it are extremely cautious … People who need it most may not be in a position to accept the fact they need it. Involuntary administration should be the very last resort. There should always be a surrogate acting for the patient. Every step should be taken to minimize any consideration of involuntary ECT.”

“We feel strongly that it should be among the treatment options. We are aware of side effects and short-term memory loss. We don’t minimize these, nor downplay the fact that it is a powerful and dramatic treatment. On the balance, though, the benefits and detriments show evidence on the positive side. It may produce short-term memory loss, and may be permanent regarding the events surrounding the actual treatment. However, there is no evidence that the severe memory loss is permanent.”

“The majority of our members feel it is important not to make this a political issue. As far as alternative treatments go, less invasive treatments should be tried for major depressions. ECT should be used only when people don’t respond to traditional treatments. Persons should be fully apprised of the risks and benefits of the treatment. Significant family members in care giving roles should be fully informed regarding benefits and potential detriments.”

1.Consensus Conference. Electroconvulsive Therapy. JAMA 254:2103-2108, 1985.
2 Hermann RC, Dorwart RA, Hoover CW, Brody J. Variation in ECT Use in the United States. Am J Psychiatry 152:869-875, 1995.
3. Goodwin FK. New Directions for ECT Research. Introduction. Psychopharmacology Bull 30:265-268, 1994.
4. Consensus Conference. op. cit.
5. Hearings before Public Health Committee, Texas House of Representatives. April 18, 1995.
6 Lawrence J. Voices from Within: A Study of ECT and Patient Perceptions. Unpublished Study, 1996.
7. Consensus Conference. op. cit.
8.Consensus Conference. op. cit.
9. Hermann et al. op. cit.
10. Hermann et al. op. cit.
11. American Psychiatric Association. The Practice of Electroconvulsive Therapy: Recommendations for Treatment, Training, and Privileging. A Task Force Report. Washington, DC: The Association, 1990.
12. Consensus Conference. op. cit.
13. Sackeim HA. Central Issues Regarding the Mechanisms of Action of Electroconvulsive Therapy: Directions for Future Research. Psychopharmacology Bull 30:281-308,1994.
14. Devanand DP, Dwork AJ, Hutchinson ER, Boiwig TG, Sackeim HA. Does ECT Alter Brain Structure? Am J Psychiatry 151:957-970, 1994.
15. Depression Guideline Panel. Clinical Practice Guideline Number 5, Depression in Primary Care, Vol. 2., Treatment of Major Depression. DHHS Publication No. 93-0551, Washington, D.C.: Superintendent of Documents, U.S. Government Printing Office, 1993.
16. Harvard Women’s Health Watch. November 1997, p 4.
17. Grinspoon L and Barklage NE. Depression and Other Mood Disorders. Harvard Medical School Mental Health Review. 4:14-16, 1990.
18. Olfson M, Marcus 5, Sackeim HA, Thompson J, Pincus HA. Use of ECT for the Inpatient Treatment of Recurrent Major Depression. Am J Psychiatry 155:22-29, 1998.
19. Depression Guideline Panel. op. cit.
20 American Psychiatric Association. op. cit.
21 Miller U. Use of Electroconvulsive Therapy During Pregnancy. Hospital and Community Psychiatry 45: 444-450, 1994.
22. Walker R and Swartz CM. Electroconvulsive Therapy During High-Risk Pregnancy, General Hospital Psychiatry. 16:348-353, 1994.
23 American Psychiatric Association. op. cit.
24. Psychiatric Association. op. cit.
25 Consensus Conference. op. cit.
26. at Hearing before Public Health Committee, Texas House of Representatives, April 18, 1995.
27. Cauchon D. Controversy and Questions, Shock Therapy. USA TODAY December 5, 1995.
28. Lawrence J. op. cit.
29. Boodman SG. Shock Therapy: It’s Back. The Washington Post September 24, 1996.
30. Boodman SG. op. cit.
31. Pettinati HM, Tamburello BA, Ruetsch CR, Kaplan FN. Patient Attitudes Toward Electroconvulsive Therapy. Psychopharmacology Bull 30:471-475,1994.
32.Pettinati et al. op. cit.
33. Consensus Conference. op. cit.
34. SB et al. Informed Consent in the Electroconvulsive Treatment of Geriatric Consumers. Bull Am Acad Psychiatry Law 19: 395-403, 1991.
35. Wisconsin Coalition for Advocacy. Informed Consent for Electroconvulsive Therapy; A Report on Violations of Consumer’s Rights by St. Mary’s Hospital. Unpublished Study, Wisconsin Coalition for Advocacy, Madison, Wisconsin 1995.
36. Wisconsin Coalition for Advocacy. ibid.
37. Psychiatric Association. op. cit.
38. Oaks D. Personal Communication, 1996.
39. Breggin P. Toxic Psychiatry: Why Therapy, Empathy and Love Must Replace the Drugs, Electroshock and Biochemical Theories of the New Psychiatry. St. Martins Press, NY, NY 1991.
40. Frank LR. Electroshock: Death, Brain Damage, Memory Loss, and Brain-Washing. J Mind andBehavior 2:489-512,1990.
41. Andre L. Personal Communication, 1996.
42. Johnson B. Personal Communication, 1996.
43. DePaul-Kelly D. Personal Communication, 1996.
44. Honberg R. Personal Communication, 1996.
45. Nokes M. Personal Communication, 1997.
46. Decker C. Personal Communication, 1996.
47. Johnson SY Regulatory Pressures Hamper the Effectiveness of Electroconvulsive Therapy. Law and Psychology Rev 17:155-170, 1993.
48. Leong GB. Legal and Ethical Issues in ECT. Psychiatr Clin North Am 14:1007- 1021,1991.
49. Parry J. Legal Parameters of Informed Consent Applied to Electroconvulsive Therapy. Mental and Physical Disability Law Reporter 9:162-169, 1985.
50. Levine S. op. cit.
51. Levine S. op. cit.
52. Consensus Conference. op. cit.

CMHS censors Linda Andre

Censored!

The Center for Mental Health Services contracted Linda Andre, head of Committee for Truth in Psychiatry, the largest group of shock survivors, to write the following for its ECT report.

But CMHS bowed to heavy pressure from NAMI and the NDMDA, who lobbied hard to keep negative information from the report. CMHS, after hiring Ms. Andre, censored her material.

Here at ect.org we bring you the censored material! Exclusive!

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What position does your organization hold on the use of ECT?

First, our organization is unique in being the national organization of and for persons who have received ECT. We are the only organization that can claim to represent ECT survivors or recipients (there being no such thing as an ECT consumer). We are not industry-funded or industry-backed, like other organizations wrongly construed by CMHS to be “consumer” organizations (NDMDA, NAMI) and we do not include family members (NAMI). The agendas of those groups are necessarily very different from ours.

Our founding purpose, back in 1984, was to advocate for truthful informed consent to shock. Shock, as a brain-damaging and permanently life-altering procedure, should never be given without fully informed consent, including when the patient is technically or really involuntary and when the patient is alleged or adjudicated incompetent. We and our allies, such as all 50 federal Protection and Advocacy agencies, have struggled toward that goal for 13. years. At this point we realize that while informed consent may, theoretically, be the law of the land, in real life it is politically impossible to achieve—it is opposed, for instance, by the powerful American Psychiatric Association, which misleads patients with the totally fake “statistic” that only “1 in 200″ instead of all persons have permanent memory loss. Since patients cannot have the protection of informed consent before shock, nor can they find redress for lack of informed consent after the fact, a majority of our membership now supports a total ban on shock. But we have not yet formally changed our position statement to reflect the political reality of 1997.

What do you think about involuntary administration of ECT?

Forced shock is the most profound violation of the human spirit imaginable. The use of force is a second injury superimposed upon the damage of the actual shock itself.

It is arguable that forced treatment (of any kind, and especially of the most drastic somatic variety) is a violation of the U.S. Constitution—that is, if constitutional rights are thought to be applicable to mere mental patients. We reject CMHS’ position that this is a matter for states to decide.

CTIP members have experienced the entire spectrum of involuntary ECT. The spectrum begins with lack of informed consent; in that sense all patients have involuntary ECT. Then there are gradations of coercion including pressure from family members acting under the instructions of doctors, director indirect pressure from insurance companies unaware of the long term costs of shock, outright threats of what the patient most fears if she does not sign for shock (depending on the patient, this could be being committed; being released without other treatment; being rejected by a doctor; losing housing). At the other end of the spectrum is court-ordered involuntary shock.

What’s your position on ECT’s effectiveness and safety?

Even the industry-generated “literature” is divided on the issue of efficacy. The longest industry researchers have been able to show any benefit from shock is four weeks. There is no longer any disagreement in the industry that shock’s benefits are temporary.

Some researchers have concluded that there is no difference in efficacy between shock and sham or placebo shock. For example, Dr. Graham Shepard of England carefully reviewed all the existing sham vs. real studies, concluded that there were errors in the research, and that no evidence exists for the efficacy of shock. No one has refuted his findings. Not surprisingly, his study has not been allowed to be published, since a small group of hard-core shock promoters and publicists act as gatekeepers at all the journals where it could have found an audience.

ECT is always damaging to brain, memory, and cognition, and this in turn is devastating to personal integrity and sense of self. Ironically, it destroys the very foundations of what we call “mental health.” The disabling effects, unlike the effects on depression, are permanent.

What do you feel about ECT as a treatment option?

We believe ECT is only brain damage and that objective scientific investigation will prove this. We are in favor of such an investigation, while the shock industry (APA) opposes it. Even before an investigation, these facts speak volumes about the nature of shock.

The question could be revised to read, “What do you feel about brain damage as a treatment option?” There may be those who are in favor of brain damage for mental patients. We are not among them. Brain damage is not a treatment option.

There is no justification for using this procedure on humans unless and until it is proven safe to the brain by researchers outside the shock industry.

As long as shock continues to be used, it must be followed by intensive rehabilitation and retraining. This should include cognitive rehabilitation of the type offered to survivors of other head injuries, support groups of survivors to share self- rehabilitation strategies, and job retraining.

In general terms, how has your organization been involved with ECT since 1985?

We organized the year before, after having come together to speak out as survivors at the FDA, to advocate for truthful informed consent to ECT and for an objective scientific investigation of the effects of shock on the brain.

In 1985, we advocated for survivor involvement in the NIMH Consensus Conference on ECT, which was overwhelmingly biased in favor of the men who make their livings and reputations promoting shock as safe when it is not. Two of our members spoke on a panel and many others attended and spoke from the floor.

Since our groups efforts have largely centered around the Food and Drug Administration, it is necessary to briefly describe events before 1985. In 1982 the American Psychiatric Association, allowing a handful of shock doctors on a “Task Force” to speak for the group as a whole, came out against an investigation of shocks effects on the brain by submitting a petition for reclassification of the shock machine to the FDA. (Shock was, largely due to the efforts of survivors and our allies, classified as a Class III device in 1979; Class III devices must by law be fully investigated for safety. Class II devices need not be investigated, so a reclassification to Class If would circumvent a safety investigation.) Since 1982 and continuing to the present day, we have encouraged survivors (whether members or not) to write to the FDA documenting their experiences, and have been successful in that the FDA Docket 82P-031 6 now contains the largest collection of survivor reports in the world. We also submitted three petitions to the FDA: one for a before-and-after CAT scan study of shocked animals, one asking FDA to mandate an informed consent statement written by survivors and containing truthful information about shock’s effects on memory and cognition, and another (actually dozens of individual petitions) volunteering our own brains for a CAT scan study of shock’s effects. We are very proud of having prevented the reclassification of the ECT device for the past 1 5 years; as long as the reclassification does not take place, the door is open for a safety investigation to take place one day, an investigation that is nearly sixty years overdue.

In 1990, when the Safe Medical Devices Act was being drafted, we organized to exempt the shock machine from automatic reclassification to Class II without a safety investigation.

From 1985 to the present, members worked at the state level towards changing state consent forms- – -often modeled on the APA’s or manufacturers’ fraudulent forms- – -to truthful statements. Sometimes we were partially successful (Texas, 1992) and sometimes we were not (New York, 1993). We also helped introduce a bill for reporting shock statistics in Texas (which was successful) and New York (which was not).

Our membership grew thirtyfold from 1985 to the present as people continued to receive what APA fraudulently called “new and improved” ECT without informed consent, and continued to suffer brain damage and memory loss.

Can you tell me some of your members’ experiences?

First, it is important to note that none of the other so-called consumer organizations surveyed here by CMHS have any data on how many of their members have had shock, let alone how representative those members are of the majority of persons who receive shock. CTIP, on the other hand, has collected and documented the experiences of thousands of persons.

All of our 500 members have signed a membership form which states: “I have had ECT (shock treatment) and I know or suspect that I was not truthfully informed about its nature or consequences. In the interests of protection of future patients, I endorse the statement of “Patient Information About ECT” that has been proposed to the FDA by the Committee for Truth in Psychiatry, and, in so doing, I become a member of the Committee.”

The survivor-written “Patient Information About ECT” which all our members agree is representative of their experiences reads, in relevant part:

ECT has one adverse effect that occurs in all cases. That is memory loss. During a course of treatment a patient experiences a cumulative eradication of memory, which begins with recent events and learning (including worries), and gradually extents to the distant past. Once the course is ended, memory gradually returns in reverse time order until, in about a month, the patient has regained the main outlines of her or his personal memory and also knowledge and skills acquired early in life. After this length of time there is little further automatic return of memory, although a good deal more has become strong enough that it can be later revived by reminders or efforts at relearning.

The extent of the permanent loss varies with number of treatments, age of patient, placement of electrodes, and other factors, but the pattern of the loss is the same for all patients. The loss is total or near total for the period of the ECT course and tapers back over previous years with smoothly diminishing severity and no precise cut-off point. The patient’s remaining memory appears “spotty” in that the smooth amnesic blanket has merely dimmed some memories but submerged others, depending upon their original relative clarity.

In addition to this erasure of pre-shock memory, which is certain to occur, there may be a permanent adverse effect upon memory function after the shocking. That is, the patient’s memory for new experiences and new learning may fade rapidly.

Some patients do not mind their memory changes and seldom have occasion to notice them. At the opposite extreme are persons whose work or way of life is made impossible by them. In between are persons who gradually adjust to various degrees of handicap.

CTIP has collected information about the nature and extent of the permanent cognitive disability that often results from shock treatment, but which is almost entirely absent from articles allowed to be published in the mainstream “scientific” literature. In this effort, CTIP encourages survivors to have brain imaging and neuropsychological testing for brain damage, and to share the results of these tests with other survivors and professionals. At least a dozen CTIP members have undergone testing. The results not only unequivocally show brain damage in all cases, but are strikingly consistent: that is, shock brain damage shows up in the same manner in all survivors. In some cases survivors have suffered significant losses in IQ scores.

In 1991 CTIP published some of these findings in a paper written for the National Head Injury Foundation, titled “Electroshock as Head Injury.” Many of our members have undergone formal cognitive rehabilitation for head injury (brain damage) and report that it has helped them but that professional denial of iatrogenic brain damage made access to rehabilitation services difficult. With professional help hard to find, our members share strategies for self-rehabilitation. CTIP is the only source for such information.

Memory and cognitive losses, though profound in themselves, are frequently only the beginning of a chain of losses which result from them and can be lifelong. Examples typical of our membership are: loss of relationships with others including spouses and children, loss of job and career, loss of socioeconomic status, loss of earning capacity—to sum up in two words frequently used by our members, loss of self.

From the perspective of the consumer, what do you think are the overall benefits and risks of ECT?

Because of the fraud and deception involved in the “choice” to get ECT even under the best of circumstances, there are no “consumers” getting shock.

One can’t talk of benefits without asking: who benefits? Even the published “literature” which is favorable to ECT to the point of fraud, can claim only one benefit: relief from depression for up to four weeks. That same “literature” as summed up by the Consensus Conference estimated the average memory loss from shock to be eight weeks. The patient typically won’t even remember the period during which he or she “benefited.” Family members and doctors, then, are the only real beneficiaries.

A “benefit” frequently claimed by shock proponents- – -that shock somehow prevents suicide- – -is a public- relations ploy. There is no evidence for this claim.

Unlike the benefit, risks and costs are permanent and lifelong. Permanent memory loss is a certainty, not a risk; the variable is how much memory will be lost. Even a patient who is fully informed of how severe memory loss can be—as no ECT patient ever is—can only guess as to the ways her life will be affected by the loss. Given the extremely high value we as a society place on memory and mental competence, it is a rare patient who would find that the benefit of shock outweighs its risks…that is, if she were allowed to weigh them freely, with full and truthful information.

Ideally, patients would be informed that cognitive function (i.e. short term memory, attention, concentration, and intellectual abilities, including IQ) frequently does not return to normal after shock and should they decide to risk this, would make preparations—if possible—to survive after shock with less ability to think clearly, plan, remember, and work.

What would you say the key issues for this report are?

The report was called for by psychiatric survivors and shock survivors. It was to have looked into involuntary shock, and specifically the federal governments funding of it. Since, as of 1/17/97, it no longer intends to deal with involuntary shock, there is no reason for it to exist at all. There is no need for yet another selective “literature review” summarizing the viewpoints of those who benefit financially from the use of shock. CMHS has done this before, FDA has done it, anyone with a computer can do it.

The Government should have used this report to answer to its constituents, the survivors, and to give voice to them. The power imbalance between wealthy and powerful doctors and the most stigmatized group in our society—mental patients usually impoverished as a direct result of “treatment”- – - is so great that survivor voices have had no outlet. This does not prove that doctors are somehow right and survivors are wrong, or crazy, or liars. However this is what appears to be the case when only the words of shock doctors are considered.

Specifically what needs to be done in terms of future research?

First and foremost: an objective scientific investigation of the effects of shock on the brain. This should involve modern brain-imaging technology to scan brains before and several months after shock, to compare them. It shouldn’t be necessary to add that the patients should be getting shock for the first time and should be free of any complicating neurological problem or disease; however it is necessary to add this since shock doctors, in an attempt to blame anything but shock for abnormal brain scans, have muddied their own “research” in this manner.

The Janis memory studies of the 1950s should be replicated. Testing pre-and post-shock should include memory tests designed by survivors, not shock doctors.

Neuropsychological testing of survivors needs to be done to assess memory and non- memory cognitive function. These tests are designed not to require a “pre” test (they are used to asses brain damage in other types of head trauma which cannot be foreseen).

Research should be done on the social and economic costs of ECT. Researchers need to look at the ways in which a family is affected by one person having shock (continuing the work done by Carol Warren on women who had shock in the 50s and 60s). The costs to society of lost productivity and lifetime Social Security disability payments to persons who worked prior to shock need to be documented and factored into any assessment of shock’s cost-effectiveness.

What alternative treatments would you recommend?

We do not recommend any treatments; that is not our purpose.

The alternative to using a procedure which has not been tested for safety, and for which overwhelming evidence of unreasonable risk exists, is not to use the procedure unless and until it is proven to be safe.

What do you see needs to be looked at in terms of education for the healthcare personnel involved with ECT?

Most healthcare personnel get their information from other professionals. Whether or not they themselves make money from shock, they have an investment in believing that mass deception and fraud on the scale practiced in the shock industry does not, could not happen. They need to be educated by survivors, and this needs to happen while they are still in school, before they have too great an investment in “professionalism” and the income that goes with it.

The consumer?

The shock “consumer” does not exist; “consumer” implies choice. Patients need to be able to get information from survivors before having shock, not after when it is too late. Educational materials developed by survivors must be available to patients who are incarcerated as well as outpatients. All currently available “educational” material such as videos was made by shock machine companies and/or doctors who make a living doing shock; such materials should clearly be labeled as shock advertisements and should in no case be used to obtain legal consent.

The family of the patient?

The only answer to that is “that depends”. Families can be extremely toxic, extremely supportive, or anything in between. In some cases, such as when the patient objects, families should not be involved at all. In no case should hospital staff employ families to coerce or threaten patients or otherwise fraudulently obtain their signature on the consent form; however, the experience of our members suggests this practice is widespread. When the patient agrees, the family should have access to survivor-written materials or survivor videos. Informed consent for family members should include consideration of the possible ways the entire family may be affected if the patient has shock. Sometimes the patients agenda and the agenda of other family members are irreconcilable.

Which experts do you feel are crucial to a full examination of ECT?

Survivors, and survivor groups which are independent of industry influence and funding, are the experts on shock.

The current situation with respect to shock doctor “experts” is unethical and perhaps illegal. It is impossible to name one of these self-selected “experts”— Fink, Weiner, Sackeim, Abrams, Kellner, Coffey, Welch, etc.—who does not own a shock machine company, receive “research” money from shock machine companies, make videos for shock machine companies, “consult” or work for these companies, make money defending shock doctors and shock machine companies in court, and/or make money directly from giving shock.

It is crucial that these “experts” not be included in a full examination of ECT.

APA Task Force Report on ECT

The Practice of Electroconvulsive Therapy:

Recommendations for
Treatment, Training,
and Privileging

A Task Force Report of the American Psychiatric Association

The APA Task Force on Electroconvulsive Therapy:

Richard D. Weiner, M.D., Ph.D. (Chairperson)
Max Fink, M.D.
Donald W. Hammersley, M.D.
Iver F. Small, M.D.
Louis A. Moench, M.D.
Harold Sackeim, Ph.D. (Consultant)

APA Staff

Harold Alan Pincus, M.D.
Sandy Ferris

Published by the American Psychiatric Association
1400 K Street, N.W.
Washington, DC 20005

——————————————————————————–

11.4.3. Electrical Safety Considerations

a) The device’s electrical grounding should not be bypassed. ECT devices should be connected to the same electrical supply circuit as all other electrical devices in contact with the patient, including monitoring equipment (see Section 11.7).

b) Grounding of the patient through the bed or other devices should be avoided, except where required for physiological monitoring (see Section 11.7).

11.5. Stimulus Electrode Placement

11.5.1. Characteristics of Stimulus Electrodes

Stimulus electrode properties should be in conformance with any applicable national device standards.

11.5.2. Maintenance of Adequate Electrode Contact

a) Adequate contact between stimulus electrodes and the scalp should be assured. Scalp areas in contact with stimulus electrodes should be cleansed and gently abraded.

b) The contact area of the stimulus electrodes should be coated with a conducting gel, paste, or solution prior to each use.

c) When stimulus electrodes are placed over an area covered by hair, a conducting medium, such as a saline solution, should be applied; alternatively, the underlying hair may be clipped. Hair beneath the electrodes should be parted prior to application of the stimulus electrodes.

d) Stimulus electrodes should be applied with sufficient pressure to assure good contact during stimulus delivery.

e) Conducting gel or solution should be confined to the area under the stimulus electrodes, and should not spread across the hair or scalp between stimulus electrodes.

f) A means of assuring the electrical continuity of the stimulus path is encouraged (see Section 11.4.1.(g)).

11.5.3. Anatomic Location of Stimulus Electrodes

a) Treating psychiatrists should be familiar with the use of both unilateral and bilateral stimulus electrode placement.

b) The choice of unilateral versus bilateral technique should be made on the basis of an ongoing analysis of applicable risks and benefits. This decision should be made by the treating psychiatrist in consultation with the consentor and the attending physician. Unilateral ECT (at least when involving the right hemisphere) is associated with significantly less verbal memory impairment than is bilateral ECT, but some data suggest that unilateral ECT may not always be as effective. Unilateral ECT is most strongly indicated in cases where it is particularly important to minimize the severity of ECT-related cognitive impairment. On the other hand, some practitioners prefer bilateral ECT in cases where a high degree of urgency is present and/or for patients who have not responded to unilateral ECT.

c) With bilateral ECT, electrodes should be placed on both sides of the head, with the midpoint of each electrode approximately one inch above the midpoint of a line extending from the tragus of the ear to the external canthus of the eye.

d) Unilateral ECT should be applied over a single cerebral hemisphere. Most practitioners using unilateral electrode placement routinely place both electrodes over the right hemisphere, since it is usually nondominant with respect to language even for the majority of left-handed individuals. Stimulus electrodes should be placed far enough apart so that the amount of current shunted across the scalp is minimized. A typical configuration involves one electrode in the standard frontotemporal position used with bilateral ECT, and the midpoint of the second electrode one inch ipsilateral to the vertex of the scalp (d’Elia placement).

e) Care should be taken to avoid stimulating over or adjacent to a skull defect.

11.6. Stimulus Dosing

a) The primary consideration with stimulus dosing is to produce an adequate ictal response (see Sections 11.8.1 and 11.8.2). Regardless of the specific dosing paradigm used, whenever seizure monitoring (see Section 11.7.2) indicates that an adequate ictal response has not occurred, restimulation should be carried out at a higher stimulus intensity.

Informed Consent

Since a considerable time period is involved, however, care should also be taken to ensure that the informed consent process continues across the complete period during which ECT is administered. Patient memories of consent for medical and surgical procedures in general are commonly faulty (Roth et al. 1982; Meisel and Roth 1983). For patients receiving ECT, this difficulty with recall may be exacerbated by both the underlying illness and the treatment itself (Sternberg and Jarvik 1976; Squire 1986). For these reasons, the consentor should be reminded in an ongoing fashion of his/her option to withdraw consent. This reminding process should also include a periodic review of clinical progress and side effects.

The occurrence of a substantial alteration in the treatment procedure or other factor having a major effect upon risk-benefit considerations should be conveyed to the consentor on a timely basis. The need for ECT treatments exceeding the range originally conveyed to the consentor as likely (see Section 11.10) represents one such example. All consent-related discussions with the consentor should be documented by a brief note in the patient’s clinical record.

Continuation/maintenance ECT (see Section 13) differs from a course of ECT in that its purpose is the prevention of relapse or recurrence, and that it is characterized by both a greater inter-treatment interval and a less well-defined endpoint. Because the purpose of continuation/maintenance treatment differs from that used in the management of an acute episode, new informed consent should be obtained prior to its implementation. As a series of continuation ECT typically lasts at least 6 months, and because continuation/ maintenance ECT is, by its nature, provided to individuals who are in clinical remission and who are already knowledgeable regarding this treatment modality, a 6-month interval before readministration of the formal consent document is adequate.

There is no clear consensus as to who should obtain consent. Ideally, consent should be obtained by a physician who has both an ongoing therapeutic relationship with the patient and, at the same time, has knowledge of the ECT procedure and its effects. In practice this can be accomplished by the attending physician, treating psychiatrist, or their designees acting individually or in concert.

Information Provided

The use of a formal consent document for ECT ensures the provision of at least a minimum measure of information to the consentor, although consent forms vary considerably in scope, detail, and readability. For this reason, a sample consent form and sample supplementary patient information material are included in Appendix B. If these documents are used, appropriate modifications should be made to reflect local conditions. It is also suggested that any reproductions be in large type, to ensure readability by patients with poor visual acuity.

Earlier task force recommendations (American Psychiatric Association 1978), other professional guidelines, and regulatory requirements (Mills and Avery 1978; Tenenbaum 1983; Winslade et al. 1984; Taub 1987; Winslade 1988), as well as a growing concern regarding professional liability, have encouraged the use of more comprehensive written information as part of the ECT consent process. Such material is often contained wholly within the formal consent document, while others use an additional supplementary patient information sheet. A copy of the major components of such information should be given to the consentor to facilitate learning and understanding of the material and assimilation by significant others.

To rely entirely upon the consent form as the sole informational component of the informed consent process would be ill-founded. Even with considerable attention to readability, many patients understand less than half of what is contained in a consent form (Roth et al. 1982). It is interesting to note, however, that psychiatric patients do not perform more poorly than medical or surgical cases (Meisel and Roth 1983). Besides problems with limited patient comprehension, members of the treatment team may see the consent form as relieving them of any additional responsibility to supply information to the patient/consentor over the ECT course. Alternatively, the consentor may perceive the signing of the consent form as a single, final act in the consent process, after which the matter is “closed.” Both of these attitudes should be eschewed.

The written information supplied within and accompanying the consent document should be supplemented by a discussion between the consentor and the attending physician, treating psychiatrist and/or designee, that highlights the main features of the consent document, provides additional case-specific information, and allows an exchange to take place. Examples of case-specific information include: why ECT is recommended, specific applicable benefits and risks, and any planned major alterations in the pre-ECT evaluation or the ECT procedure itself. Again, as with all significant consent related interactions with the patient and/or consentor, such discussions should be briefly summarized in the patient’s clinical record.

To improve the understanding of ECT by patients, consentors, and significant others, many practitioners use additional written and audiovisual materials, which have been designed to cover the topic of ECT from the layman’s perspective. Videotapes, in particular, may be helpful in providing information to patients with limited comprehension, although they may not serve as a substitute for other aspects of the informed consent process (Baxter et al. 1986). A partial listing of such materials has been included as part of Appendix C.

The scope and depth of informational material provided as part of the consent document should be sufficient to allow a reasonable person to understand and evaluate the pertinent risks and benefits of ECT as compared to treatment alternatives. Since individuals vary considerably in terms of education, intelligence, and cognitive status, efforts should be made to tailor information to the consentor’s ability to comprehend such data. The practitioner should be aware that too much technical detail can be as counterproductive as too little.

The specific topics to be covered in the consent document generally include the following: 1) a description of the ECT procedure; 2) why ECT is being recommended and by whom; 3) applicable treatment alternatives; 4) the likelihood and anticipated severity of major risks associated with the procedure, including mortality, adverse effects upon cardiovascular and central nervous systems, and common minor risks; 5) a description of behavioral restrictions that may be necessary during the pre-ECT evaluation period, the ECT course, and the recuperative interval; 6) an acknowledgement that consent for ECT is voluntary and can be withdrawn at any time; and 7) an offer to answer questions regarding the recommended treatment at any time, and the name of whom to contact for such questions.

The description of the ECT procedure should include the times when treatments are given (e.g., Monday, Wednesday, Friday mornings), general location of treatment (i.e., where treatments will take place), and typical range for number of treatments to be administered. In the absence of precise quantitative data, the likelihood of specific adverse effects is generally described in terms such as “extremely rare,” “rare,” “uncommon,” and “common” (see Section 4). Because of ongoing concern regarding cognitive dysfunction with ECT, an estimate of the potential severity and persistence of such effects should be given (see Section 4). In light of the available evidence, “brain damage” need not be included as a potential risk.

Capacity and Voluntariness to Provide Consent

Informed consent is defined as voluntary. In the absence of consensus as to what constitutes “voluntary,” it is defined here as the consentor’s ability to reach a decision free from coercion or duress.

Since the treatment team, family members, and friends all may have opinions concerning whether or not ECT should be administered, it is reasonable that these opinions and their basis be expressed to the consentor. In practice, the line between “advocacy” and “coercion” may be difficult to establish. Consentors who are either highly ambivalent or are unwilling or unable to take full responsibility for the decision (neither of which are rare occurrences with patients referred for ECT) are particularly susceptible to undue influence. Staff members involved in clinical case management should keep these issues in mind.

Threats of involuntary hospitalization or precipitous discharge from the hospital due to ECT refusal clearly represent a violation of the informed consent process. However, consentors do have the right to be informed of the anticipated effects of their actions on the patient’s clinical course and the overall treatment plan. Similarly, since physicians are not expected to follow treatment plans which they believe are ineffective and/or unsafe, an anticipated need to transfer the patient to another attending physician should be discussed in advance with the consentor.

It is important to understand the issues involved in a consentor’s decision to refuse or withdraw consent. Such decisions may sometimes be based upon misinformation or may reflect unrelated matters, e.g., anger towards self or others or a need to manifest autonomy. In addition, a patient’s mental disorder can itself severely limit the ability to cooperate meaningfully in the informed consent process, even in the absence of psychotic ideation. Patients who are involuntarily hospitalized represent a special case. A number of suggestions have been offered to help guarantee the right of such individuals to accept or refuse specific components of the treatment plan, including ECT. Examples of such recommendations include the use of psychiatric consultants not otherwise involved in the case, appointed lay representatives formal institutional review committees, and legal or judicial determination. While some degree of protection is indicated in such cases, overregulation will serve to limit the patient’s right to receive treatment.

Informed consent requires a patient who is capable of understanding and acting intelligently upon information provided to him/her. For the purpose of these recommendations, the term the chronic dysthymia or whether dysthymic symptomatology also improves. However, some practitioners believe that dysthymic symptoms do improve and that focusing treatment termination on resolution of the major depressive episode alone may result in incomplete treatment, with possible heightened risk of relapse. In contrast, some patients with schizoaffective disorder present with relatively chronic forms of thought disorder (e.g., delusions), upon which is superimposed prominent episodic affective symptomatology. In a number of these patients, ECT may ameliorate the affective component without influencing the chronic thought disorder. Prolonging the ECT course to attempt such resolution may result in unnecessary treatment.

After the start of ECT, clinical assessments should be performed by the attending physician or designee after every one or two treatments. These assessments should preferably be conducted on the day following a treatment to allow for clearing of acute cognitive effects and should be documented. The assessments should include attention to changes in the episode of mental disorder for which ECT has been referred, both in terms of improvement in signs and symptoms present initially and the manifestation of new ones. During the course of ECT, switches from depression to mania may occur on an uncommon basis. In this context, it is important to distinguish between an organic euphoric state and mania (Devanand et al. 1988b) (see also Section 11.9). Formal assessment of changes in cognitive functioning may help in making this differential diagnosis.

In patients treated for prominent catatonic symptomatology, the nature of other symptoms may have been difficult to discern at pretreatment due to mutism or negativism. With introduction of ECT and the clearing of catatonia, other aspects of psychopathology may become evident and should be assessed and documented. Some patients may have experienced delusions or hallucinations prior to or during the ECT course, but, due to patient guardedness or other factors, these symptoms may have been difficult to verify With clinical improvement, the clinician may ascertain their presence, a determination which may impinge on discharge planning and future treatment.

12.2. Adverse Effects

Cognitive changes. The impact of ECT on mental status, particularly regarding orientation and memory functioning, should be assessed both in terms of objective findings and patient report during the ECT course (see Section 4). This assessment should be conducted prior to the start of ECT in order to establish a baseline level of functioning and repeated at least weekly throughout the ECT course. It is suggested that cognitive assessment, like assessment of therapeutic change, be conducted at least 24 hours following an ECT treatment to avoid contamination by acute postictal effects.

The evaluation may include either bedside assessment of orientation and memory and/or more formal test measures. It should include determination of orientation in the three spheres (person, place, and time), as well as immediate memory for newly learned material (e.g., reporting back a list of three to six words) and retention over a brief interval (e.g., reporting back the list 5�10 minutes later). Remote recall might likewise be assessed by determining memory for events in the recent and distant past (e.g., events associated with the hospitalization, memory for personal details� address, phone number, etc.).

Formal testing instruments provide quantitative measures for tracking change. To assess global cognitive functioning, an instrument such as the Mini-Mental State exam (Folstein et al. 1975) may be used. To track orientation and immediate and delayed memory, subtests of the Russell revision of the Weschler Memory Scale could be used (Russell 1988). To formally assess remote memory, tests of recall or recognition of famous people or events can be used (Butters and Albert 1982; Squire 1986). When cognitive status is assessed, the patient’s perception of cognitive changes should also be ascertained. This may be done by informally inquiring whether the patient has noticed any changes in his/her abilities to concentrate (e.g., to follow a television program or a magazine article) or to remember visitors, events of the day, or recall of more remote events. Patient perception of memory functioning may also be examined using a quantitative instrument (Squire et al. 1979).

In the event that there has been a substantial deterioration in orientation or memory functioning during the ECT course that has not resolved by discharge from the hospital, a plan should be made for post-ECT follow-up of cognitive status. Most commonly there is marked recovery in cognitive functioning within days of the end of the ECT course (Steif et al. 1986) and patients should be reassured that this will likely be the case. The plan should include a description of when follow-up assessment would be desirable, as well as the specific domains of cognitive function to be assessed. It may be prudent in such cases to conduct additional evaluations, e.g., neurological and electroencephalographic examinations, and if abnormal to repeat until there is resolution.

It should be kept in mind that the cognitive evaluation procedures suggested here provide only gross measures of cognitive status. Furthermore, interpretation of changes in cognitive status may be subject to a number of difficulties. Psychiatric patients frequently have cognitive impairments prior to receiving ECT and a therapeutic response may therefore be associated with improvement in some cognitive domains (Sackeim and Steif 1988). However, while some patients show improved scores relative to their pre-ECT baseline, they still may not have fully returned to their baseline level of cognitive functioning (Steif et al. 1986). This discrepancy may be a basis for complaints about lingering cognitive deficits. In addition, the procedures suggested here only sample limited aspects of cognitive functioning, for example, deliberate learning and retention of information. Patients may also have deficits in incidental learning. Likewise, the suggested procedures concentrate on verbal memory, although both right unilateral and bilateral ECT produce deficits in memory for nonverbal material (Squire 1986).

Other adverse effects. During the ECT course, any onset of new risk factors, or significant worsening of those present at pre-ECT, should be evaluated prior to the next treatment. When such developments alter the risks of administering ECT, the consentor should he informed and the results of this discussion documented. Patient complaints about ECT should be considered adverse effects. The attending physician and/or a member of the ECT treatment team should discuss these complaints with the patient, attempt to determine their source, and ascertain whether corrective measures are indicated.

13. Management of Patient’s Post-ECT Course

Continuation therapy, which is defined as the extension of somatic therapy over the 6-month period following induction of a remission in the index episode of mental illness, has become the rule in contemporary psychiatric practice. Exceptions may include patients who are intolerant to such treatment and possibly those with either an absence of prior episodes or a history of extremely long periods of remission (although compelling evidence for the latter is lacking). Unless residual adverse effects necessitate a delay, continuation therapy should be instituted as soon as possible after remission induction, since the risk of relapse is especially high during the first month. Some practitioners believe that the onset of symptoms of impending relapse in patients who are ECT responders may represent an indication for institution of a short series of ECT treatments for a combination of therapeutic and prophylactic purposes, although controlled studies are not vet available to substantiate this practice.

Continuation pharmacotherapy. A course of ECT is usually completed over a 2- to 4-week period. Standard practice, based in part on earlier studies (Seager and Bird 1962; Imlah et al. 1965; Kay et al. 1970), and in part on the parallel between ECT and psychotropic drug therapies, suggests continuation of unipolar depressed patients with antidepressant agents (with the possible addition of an antipsychotic drug in cases of psychotic depression),bipolar depressives with antidepressant and/or antimanic medications; and manics with antimanic and possibly antipsychotic agents. For the most part, dosages are maintained at 50%�100% of the clinically effective dose range for acute treatment, with adjustment up or down depending upon response. Still, the role of continuation therapy with psychotropic drugs after a course of ECT is undergoing assessment, and our recommendations should be considered provisional. Disappointment with high relapse rates, especially in patients with psychotic depression and in those who are medication resistant during the index episode (Sackeim et al., 1990), compels reconsideration of present practice, including a renewed interest in continuation ECT (Fink 1987b).

Continuation ECT. While psychotropic continuation therapy is the prevailing practice. few studies document the efficacy of such use after a course of ECT, and some recent studies report high relapse rates even in patients complying with such regimens (Spiker et al. 1985; Aronson et al. 1987, 1988a, 1988b; Sackeim et al., in press). These high relapse rates have led some practitioners to recommend continuation ECT for selected cases. Recent retrospective reviews of this experience find surprisingly low relapse rates among patients so treated, although controlled studies are not yet available (Kramer 1987; Decina et al. 1987; Clarke et al. 1989; Loo et al. 1988; Matzen et al. 1988; Thornton et al. 1988). Because continuation ECT appears to represent a viable form of continuation management of patients following completion of a successful course of ECT, facilities are encouraged to offer this modality as a treatment option. Patients referred for continuation ECT should meet all of the following criteria: 1) history of recurrent illness that is acutely responsive to ECT; 2) either refractoriness or intolerance to pharmacotherapy alone or a patient preference

Appendix B

Examples of Consent Forms and Patient Information Sheet for an ECT Course
[Name of Facility Here]

ECT Consent Form

Name of Attending Physician:

Name of Patient: ______________________________________

My doctor has recommended that I receive treatment with electroconvulsive Therapy (ECT). The nature of this treatment, including the risks and benefits that I may experience have been fully described to me and I give my consent to be treated with ECT.

I will receive ECT to treat my psychiatric condition. I understand that there may be other alternative treatments for my condition which may include medications and psychotherapy. Whether ECT or an alternative treatment is most appropriate for me depends on my prior experience with these treatments, the nature of my psychiatric condition, and other considerations. Why ECT has been recommended for my specific case has been explained to me.

ECT involves a series of treatments. To receive each treatment I will be brought to a specially equipped room in this facility. The treatments are usually given in the morning, before breakfast. Because the treatments involve general anesthesia, I will have had nothing to drink or eat for at least six hours before each treatment. When I come to the treatment room, an injection will be made in my vein so that I can be given medications. I will be given an anesthetic drug that will quickly put me to sleep. I will be given a second drug that will relax my muscles. Because I will be asleep, I will not experience pain or discomfort during the procedure. I will not feel the electrical current, and when I wake up I will have no memory of the treatment.

To prepare for the treatments, monitoring sensors will be placed on my head and other parts of my body. A blood pressure cuff will be placed on one of my limbs. This is done to monitor my brain waves, my heart, and my blood pressure. These recordings involve no pain or discomfort. After I am asleep, a small, carefully controlled amount of electricity will be passed between two electrodes that have been placed on my head. Depending on where the electrodes are placed, I may receive either bilateral ECT or unilateral ECT. In bilateral ECT, one electrode is placed on the left side of the head, the other on the right side. In unilateral ECT, both electrodes are placed on the same side of the head, usually on the right side. When the current is passed, a generalized seizure is produced in the brain. Because I will have been given a medication to relax my muscles, muscular contractions in my body that would ordinarily accompany a seizure will be considerably softened. The seizure will last for approximately one minute. Within a few minutes, the anesthetic drug will wear off and I will awaken. During the procedure my heart rate, blood pressure, and other functions will be monitored. I will be given oxygen to breathe. After waking up from the anesthesia, I will be brought to a recovery room, where I will be observed until it is time to leave the ECT area. The number of treatments that I receive cannot be predicted ahead of time. The number of treatments will depend on my psychiatric condition, how quickly I respond to the treatment, and the medical judgment of my psychiatrist. Typically, six to twelve treatments are given. However, some patients respond slowly and more treatments maybe required. Treatments are usually given three times a week, but the frequency of treatment may also vary depending on my needs.

The potential benefit of ECT for me is that it may lead to improvement in my psychiatric condition. ECT has been shown to be a highly effective treatment for a number of conditions. However, not all patients respond equally well. As with all forms of medical treatment, some patients recover quickly; others recover only to relapse again and require further treatment, while still others fail to respond at all.

Like other medical procedures, ECT involves some risks. When I awaken after each treatment, I may experience confusion. The confusion usually goes away within an hour. Shortly after the treatment, I may have a headache, muscle soreness, or nausea. These side effects usually respond to simple treatment. More serious medical complications with ECT are rare. With modern ECT techniques, dislocations or bone fracture, and dental complications very rarely occur. As with any general anesthetic procedure, there is a remote possibility of death. It is estimated that fatality associated with ECT occurs approximately one per 10,000 patients treated. While also rare, the most common medical complications with ECT are irregularities in heart rate and rhythm.

To reduce the risk of medical complications, I will receive a careful medical evaluation prior to starting ECT. However, in spite of precautions there is a small chance that I will experience a medical complication. Should this occur, I understand that medical care and treatment will be instituted immediately and that facilities to handle emergencies are available. I understand, however, that neither the institution nor the treating physicians are required to provide long-term medical treatment. I shall be responsible for the cost of such treatment whether personally or through medical insurance or other medical coverage. I understand that no compensation will be paid for lost wages or other consequential damages.

A common side effect of ECT is poor memory functioning. The degree of disruption of memory is likely to be related to the number of treatments given and their type. A smaller number of treatments is likely to produce less memory impairment than a larger number of treatments. Right unilateral ECT (electrodes on the right-side) is likely to produce milder and shorter-lived memory impairment than that following bilateral ECT (one electrode on each side of the head). The memory difficulties with ECT have a characteristic pattern. Shortly following a treatment, the problems with memory are most pronounced. As time from treatment increases, memory functioning improves. Shortly after the course of ECT, I may experience difficulties remembering events that happened before and while I received ECT. This spottiness in memory for past events may extend back to several months before I received ECT, and in rare instances, to one or two years. Many of these memories will return during the first several months following the ECT course. However, I may be left with some permanent gaps in memory, particularly for events that occurred close in time to the ECT course. In addition, for a short period following ECT, I may experience difficulty in learning and remembering new information. This difficulty in forming new memories should be temporary and will most likely subside within several weeks following the ECT course. Individuals vary considerably in the extent to which they experience confusion and memory problems during and shortly following treatment with ECT. However, in part because psychiatric conditions themselves produce impairments in learning and memory, many patients actually report that their learning and memory functioning is improved after ECT compared to their functioning prior to the treatment course. A small minority of patients, perhaps 1 in 200, report severe problems in memory that remain for months or even years. The reasons for these rare reports of long-lasting impairment are not fully understood.

Because of the possible problems with confusion and memory, it is important that I not make any important personal or business decisions during the ECT course or immediately following the course. This may mean postponing decisions regarding financial or family matters. After the treatment course, I will begin a “convalescence period,” usually one to three weeks, but which varies from patient to patient. During this period I should refrain from driving, transacting business, or other activities for which impairment of memory may be problematic, until so advised by my doctor.

The conduct of ECT at this facility is under the direction of Dr. _________________. I may contact him/her at (phone number: ________________) if I have further questions.

I understand that I should feel free to ask questions about ECT at this time or at any time during the ECT course or thereafter from my doctor or from any other member of the ECT treatment team. I also understand that my decision to agree to ECT is being made on a voluntary basis, and that I may withdraw my consent and have the treatments stopped at any time.

I have been given a copy of this consent form to keep.

Patient:

Date Signature

Person Obtaining Consent:

Date Signature

Sample Patient Information Sheet

Electroconvulsive Therapy

Electroconvulsive therapy (ECT) is a safe and effective treatment for certain psychiatric disorders. ECT is most commonly used to treat patients with severe depression. It is often the safest, fastest, and most effective treatment available for this illness. ECT is also sometimes used in the treatment of patients with manic illness and patients with schizophrenia. Treatment for depression has improved remarkably over the past 25 years. The techniques of administering ECT have also improved considerably since its introduction. During ECT, a small amount of electrical current is sent to the brain. This current induces a seizure that affects the entire brain, including the parts that control mood, appetite, and sleep. ECT is believed to correct biochemical abnormalities that underlie severe depressive illness. We know that ECT works: 80% to 90% of depressed people who receive it respond favorably, making it the most effective treatment for severe depression.

Your physician suggests that you be treated with ECT because you have a disorder that (s) he believes will respond to ECT. Discuss this with your doctor. Before ECT begins, your medical condition will be carefully assessed with a complete medical history, physical examination and laboratory tests including blood tests and an electrocardiogram (ECG).

ECT is given as a course of treatments. The number needed to successfully treat a severe depression ranges from 4 to 20. The treatments are usually given 3 times a week�Monday, Wednesday, and Friday. You must not eat or drink anything after midnight prior to your scheduled treatment. If you smoke, please try to refrain from smoking on the morning prior to your treatment.

Before your receive the treatment, a needle will be injected into a vein so that medications can be given. Although you will be asleep during the treatment, it is necessary to begin to prepare you while you are still awake. Electrodes are placed on your head for recording your EEG (electroencephalogram or brain waves). Electrodes are placed on your chest for monitoring your ECG (cardiogram or heart rhythm). A blood pressure cuff is wrapped around your wrist or ankle for monitoring your blood pressure during the treatment. When everything is connected, the ECT machine is tested to ensure that it is set properly for you.

CONTINUING EDUCATION COURSES

FOR PSYCHIATRISTS Duke University

Visiting Fellowship: 5-day course for one or two students, designed to provide advanced training and skills in modern ECT administration. 40 CME credits.

Mini-Course: 1.5 day course designed to enable practicing clinicians to upgrade their skills in ECT. 9 CME credits.
Director: C. Edward Coffey, M.D. 919-684-5673

SUNY at Stony Brook

5-day course for four to six students, designed to provide advanced training and skills in modern ECT. 27 CME credits.
Director: Max Fink, M.D. 516-444-2929

American Psychiatric Association

At annual meetings of the APA, one-day courses are usually presented for classes of students up to 125. These are lecture/demonstrations and aim to provide discussions of such topics as treating the high-risk patient, technical aspects of treatment, and theories of ECT action. For details, see annual course offerings of APA.

Individual preceptorships

From time to time, other experienced clinicians accept visitors for varying lengths of stay at their clinics.

FOR NURSES

Courses for nurses are available at both Duke University and SUNY at Stony Brook. For information, contact Martha Cress, R.N., or Dr. Edward Coffey at Duke University, or Dr. Max Fink at SUNY at Stony Brook.

FOR ANESTHESIOLOGISTS

The courses for psychiatrists at SUNY at Stony Brook include special sessions for anesthesiologists.

Appendix D

Addresses of Present ECT Device Manufacturers in the United States and Major Characteristics of Models Offered as of February 1990

The present devices of these manufacturers meet the recommended standards of the APA Task Force on Electroconvulsive Therapy. In addition, the manufacturers distribute educational materials (books and videotapes), which are useful in learning about ECT.

ELCOT Sales, Inc.
14 East 60th Street
New York, NY 10022
212-688-0900

MECTA Corp.
7015 SW. McEwan Road
Lake Oswego, OR 97035
503-624-8778

Medcraft
433 Boston Post Road
Darien, CT 06820
800-638-2896

Somatics, Inc.
910 Sherwood Drive
Unit 17
Lake Bluff, IL 60044
800-642-6761

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