The American Psychiatric Association, a professional organization representing “36,000 psychiatric physicians,” had several suggestions for the FDA’s draft guidance for the ECT device reclassification in 2016. Some of their suggestions include:
- expanding who gets ECT to include children and adolescents, people with catatonia, mania, schizophrenia, and schizoaffective disorders
- Softening or removing safety warnings
- Advocating against mandatory neuropsychological testing
Mandated Neuropsychological Testing
Instead of meeting the FDA’s new requirement, they proposed a less rigorous testing method:
“Screening assessments covering orientation, attention, and memory in all patients prior to and during ECT would permit identification of those individuals who may require more detailed testing.
Asking patients and family members about subjective concerns about cognition during the ECT course can also identify individuals who may require more detailed testing or adjustments in ECT treatment parameters.
We recommend a staged approach to cognitive testing similar to what is used in other disorders in health care. Screening assessments covering orientation, attention, and memory in all patients prior to and during ECT would permit identification of those individuals who may require more detailed testing.”https://www.regulations.gov/comment/FDA-2014-D-1318-0169
The APA didn’t specify a particular test in their letter, so I did some research. I came across a test that resembled their suggested methods called the ElectroConvulsive Cognitive Assessment (ECCA).
“In response to the above limitations of available cognitive screening instruments for ECT in clinical practice, researchers at Emory University developed a new cognitive screening tool specific to ECT in collaboration with colleagues from the National Network of Depression Centers (NNDC).”ElectroConvulsive therapy Cognitive Assessment (ECCA) tool: A new instrument to monitor cognitive function in patients undergoing ECT – ScienceDirect
The ElectroConvulsive Cognitive Assessment ECCA
“The ElectroConvulsive Cognitive Assessment (ECCA) is a novel contribution to the literature regarding ECT and cognitive function. It provides ECT psychiatrists and other clinicians with a brief, easy to administer, bedside cognitive measure to identify ECT-related cognitive impairments early in the treatment course to adjust the ECT treatment plan.”Fuqua Center For Late-Life Depression at Wesley Woods – Emory University – Atlanta, Georgia | Fuqua Center for Late-Life Depression
People with ties to the ECT industry, including Richard D. Weiner, are involved with this test.
Wiener’s ties to the ECT industry:
“Duke University’s Richard D. Weiner, 51, chairman of the APA task force on ECT, appears on a MECTA videotape. Weiner said he served as a consultant to the company about 10 years ago but has not “received any money directly” for his services. Instead, MECTA deposited between $3,000 and $5,000 in a university account that Weiner controls which, according to a Duke spokesman, is earmarked for “research support and other educational functions.”SHOCK THERAPY: IT’S BACK – The Washington Post, 1996
Conflict of interest statement
In a paper evaluating the efficacy of the ECCA test, there are some interesting conflicts of interest among its researchers:
“RDW [Richard D. Weirner] co-inventor on a software patent licensed to MECTA, Corp., a manufacturer of ECT devices. He does not personally receive royalties”Electroconvulsive Therapy Cognitive Assessment (ECCA) tool: A new instrument to monitor cognitive function in patients undergoing ECT – ScienceDirect
This statement “he does not personally receive royalties,” is addressed in the book, Doctors of Deception, What They Don’t Want you to Know About Shock Treatment:
“Because the patent had been developed with NIMH grant money, which is paid to an institution rather than an individual, Weiner could not legally hold the patent in his own name. It was licensed to Duke University. In the 2001 APA ECT Task Force Report, Weiner belatedly disclosed this patent as well as his work for Somatics (which were not disclosed in the 1996 Washington Post article), but said he did not receive “royalties or personal payments,” making it appear as if he had made a selfless choice not to hold the patent in his name. In fact, he did not have that choice. Now Duke makes money every time one of the new machines is sold. At the same time, Weiner’s grant is paid directly to the university, as is all federal grant money.“Doctors of Deception What they Don’t Want You to Know About Shock Treatment
The harm of being denied neuropsychological testing
Many disabled by ECT have to fight to access comprehensive neurpsychological testing. The APA says this new testing method will allow them to screen who needs to be reffered for more in-depth assesments but with no standards in place, doctors continue to do whatever they want.
MAUDE reports from ECT recipients:
“…i had 9 treatments done after being evaluated and educated about the process and was told that i would only have mild temporary memory loss. Which couldn’t be further from the truth, in (b)(6) 2016 immediately after my last treatment i started telling my provider about the severe headaches and vision loss but he ignored my issue. The issues continued to come and get worse and worse. I have a headache 24/7, vision issues, nausea/vomiting, severely painful muscles and joints, lost my memory that still has not return, completely forgot how to do my job, anger, agitation, increased suicidal thoughts, my depression has never improved whatsoever, dizziness, confusion, not able to focus or remember what i’m supposed to do day to day… My psychiatrist continues to deny that my treatments had anything to do with any of these other issues. I’ve also found out information about ect’s that was never told to me.”
“I endured 9 rounds of electroconvulsive therapy from 2010 to 2011. I had over a year of intense recovery and still have difficulty. I reported problems to my dr many times, no one believed that ect could have caused it.”
“Ect’s caused perm. Seizures, bi frontal brain atrophy. Shrinking of grey and white matter in brain, perm. Cognitive physical behavioral issues. Was (b)(6) and now can’t remember how to spell. The doctors kept telling my parents my memory and seizures and talk incomplete sentences would all be fine a few months after we stopped ects, but they kept doing them even after i have positive signs of brain damage shown in two eeg’s and frontal atrophy in frontal lobes.“
“I am a shell of who i was before. All of my cognitive / executive functioning has been negatively effected. I cannot control my emotion. I get flustered easily and it is humiliating. My memory is all messed up. Events as much as 2 to 3 years before are gone. I can still remember minute details of insignificant things but may forget a conversation i just had recently with someone. I get confused, always forget where i put things, cannot get things organized and live with piles of “stuff” all over my house…no drs believe me that ect caused this, so none have done any tests.“
Read the full report
To this day I continue to see forum posts and receive emails from ECT recipients struggling to get any recognition for side effects they werent warned of. Doctors continue to tell them nothing is wrong and they don’t need refferals for testing or other support.
“36,000 psychiactric physycians” advocated against language that would better inform patients of ECT’s risks and ensure access to neurpsychological testing if they need it.
Apa Letter to the FDA
March 10th, 2016
Robert M. Califf, M.D.
U.S. Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
RE: Neurological Devices; Reclassification of Electroconvulsive Therapy Devices
Intended for Use in Treating Severe Major Depressive Episode in Patients 18
Years of Age and Older Who Are Treatment Resistant or Require a Rapid
Response; Effective Date of Requirement for Premarket Approval for
Electroconvulsive Therapy for Certain Specified Intended Uses [Docket No. FDA–
Electroconvulsive Therapy Devices for Class II Intended Uses: Draft Guidance for
Industry, Clinicians, and FDA Staff; Availability [Docket No. FDA–2014–D–1318]
Dear Commissioner Califf,
The American Psychiatric Association (APA), the national medical specialty society
representing more than 36,000 psychiatric physicians and their patients, appreciates the
opportunity to submit comments to the Food and Drug Administration (FDA) concerning
the proposed order (2014-N-1210) and draft guidance for industry, clinicians and FDA
staff (2014-D-1318) related to electroconvulsive therapy (ECT) devices.
Given the importance of ECT as a lifesaving treatment for the severely mentally ill and
the long established history of ECT safety and efficacy, the APA strongly supports the
FDA proposal to reclassify ECT devices into class II (special controls) for use in treating
severe major depressive episode (MDE) associated with major depressive disorder or
bipolar disorder in patients who are treatment resistant or who require a rapid response
due to the severity of their psychiatric or medical condition.
The extensive body of evidence for safe and effective use of ECT in the treatment of
major depressive episodes is well described in the FDA proposed order. Reports published since the FDA public hearing in 2011 include randomized trials that compare
different ECT electrode placements or stimulus parameters.
This research consistently shows substantial rates of response and remission of treatment-resistant major depressive episodes to ECT, particularly when compared to response of treatment-resistant depression to additional trials of pharmacotherapy.
In addition, analyses show rates of remission and response in individuals with bipolar depressive episodes that are generally comparable to that observed with major depressive disorder.
These data provide further support for the proposed reclassification of ECT devices to class II for major depressive episodes.
The APA recommends that a class II designation also be given for catatonia, manic episodes (in bipolar disorder), schizophrenia, and schizoaffective disorder and that the patient population in each of these illnesses be limited to individuals with treatment-resistant psychiatric disorders and/or patients with life-threatening conditions related to their underlying psychiatric condition.
We also recommend that the class II designation include ECT treatment for children and adolescents meeting the criteria for treatment resistance and in need of a potentially life-saving intervention for the conditions previously indicated and for MDE associated with major depressive disorder or bipolar disorder.
From a safety standpoint, as the FDA notes, ECT-related risks for these conditions are comparable for major depressive episodes.5 Evidence from peer-reviewed scientific literature, which meets the FDA definition of valid scientific evidence, supports the benefits of ECT in these conditions.6
This research is summarized below and includes reports published since the FDA public hearing in 2011, although these comments should not be construed as a complete review of all available scientific evidence.
Consequently, in individuals with treatment-resistant psychiatric conditions, or in which the patient’s symptoms are life-threatening, the probable benefit to health from use of ECT outweighs the probable injury or illness. Any reclassification should not have the unintended consequence of unfairly reducing access for such life-saving treatment.
The following includes a more detailed discussion of our recommendations, as well as our specific suggestions for how to safely and effectively deliver ECT to emergently ill patients.
Evidence for use of ECT in Catatonia
In patients with catatonia, ECT provides relief in most instances in which there is no significant response to benzodiazepines, which represent the recommended first-line treatment.7
In a randomized controlled trial (RCT) comparing ECT to risperidone in patients who did not respond to lorazepam, ECT response was found to be superior.8 Overall, response to ECT is routinely reported in 80-100 percent of catatonic patients9 with a similarly robust response rate of 75 percent in patients with catatonia who are under the age of 18 years.10
Furthermore, when insufficiently treated, catatonia is associated with significant mortality and morbidity due to complications such as dehydration,11 rhabdomyolysis with associated kidney injury, deep vein thrombosis (DVT) and subsequent pulmonary embolism (PE),12 decubitus ulcers with the possibility of infection and disseminated sepsis,13 or aspiration pneumonia.14 For these reasons, ECT is already the “gold standard” of treatment for catatonia when pharmacological approaches, such as use of benzodiazepines, are ineffective.15
Evidence for use of ECT in Mania
ECT also has demonstrated efficacy in individuals with acute manic episodes on the basis of a large case series,16 retrospective studies,17 and prospective comparison studies.18 One prospective trial compared ECT with lithium treatment;19 another compared ECT with combined treatment with lithium and haloperidol;20 a third study compared real and sham ECT in patients receiving neuroleptic treatment.21
Each of these studies found that ECT was efficacious and resulted in better short-term outcomes than the comparison treatments. In addition, a comprehensive review of the English-language literature found that response to ECT in acute mania was equivalent or superior to treatment with lithium carbonate or chlorpromazine.22
Furthermore, ECT was associated with remission or marked clinical improvement in 80 percent of 589 patients with acute mania despite the fact that a substantial number had not responded to other treatments23 and response to placebo in such patients is low.24 Case reports have also supported the efficacy of continuation ECT in patients with rapid cycling or following improvement of manic or mixed episodes to an acute course of ECT.25
Given these benefits, both national and international practice guidelines suggest ECT as an option in patients with severe, treatment-resistant mania.26
Evidence for use of ECT in Schizophrenia and Schizoaffective Disorder
In individuals with schizophrenia and schizoaffective disorder, ECT is typically administered in combination with an antipsychotic medication. In studies since 1980 that include individuals with either schizophrenia or schizoaffective disorder, therapeutic benefits are seen for ECT combined with antipsychotic medication as compared with antipsychotic medication alone or antipsychotic plus sham treatment.27 A Cochrane meta-analysis of these studies concludes that “ECT, combined with treatment with antipsychotic drugs, may be considered an option for people with schizophrenia, particularly when rapid global improvement and reduction of symptoms is desired” or “for those with schizophrenia who show limited response to medication alone.”28 In patients with schizophrenia who had not responded to clozapine, a recent randomized prospective trial found improved outcomes with a combination of clozapine and ECT as compared with continued clozapine treatment alone.29 Specifically, an acute series of ECT plus clozapine showed a 50 percent responder rate (using rigorous response criteria) compared to 0 percent for clozapine alone. In addition, when the clozapine alone subjects were then crossed over to receive combination treatment, 47 percent responded. In addition, a recent meta-analysis of the applicable published literature shows a response rate of 66 percent to clozapine in combination with ECT among patients with schizophrenia who have not responded to clozapine previously.30 When individuals with treatment-resistant schizophrenia have responded to an acute course of ECT in combination with antipsychotic medication, persistent response can often be achieved with continuation and maintenance ECT.31 In a randomized control trial of patients with treatment-resistant schizophrenia, the combination of an antipsychotic with ECT was significantly superior to ECT alone or antipsychotic alone in preventing relapse at 6 months.32 Given these benefits of ECT, practice guidelines suggest ECT as an option in patients with schizophrenia whose symptoms have not responded to antipsychotic medications particularly when symptoms include catatonia, severe and persistent psychosis, or suicidal ideation and behavior.33
Evidence for use of ECT in children and adolescents with severe and potentially life-threatening symptoms
Children and adolescents are treated infrequently with ECT. When a decision is made to use ECT in a child or adolescent, it is virtually always related to significant functional disability with a lack of response to other treatments and/or the existence of severe and potentially life-threatening symptoms such as inadequate oral intake due to catatonia, significant suicide risk, or extreme and repeated self-injury.34 Having access to a rapid and effective treatment such as ECT is especially meaningful in children and adolescents because suicide is a leading cause of death in this age group; it is the third leading cause of death in children ages 10 to 14 and the second leading cause in children ages 15 to 18.35 It is noteworthy that no death has ever been reported in a child or an adolescent that was directly related to ECT.
Information on the efficacy of ECT in youth comes primarily from retrospective studies, case series and reviews that summarize large numbers of cases.36 These peer reviewed studies provide strong clinical evidence for ECT as an effective treatment in severe and/or treatment refractory depressive episodes, mania, psychotic disorders, catatonia and neuroleptic malignant syndrome in children and adolescents. ECT is also effective in catatonia, mood and psychotic disorders when individuals have intellectual disability, autism or another developmental syndrome.37
In terms of possible cognitive effects of ECT, the available literature does not suggest a greater level of cognitive dysfunction in children and adolescents following ECT as compared to other therapeutic options.38 In addition, the very severe psychiatric illnesses that lead to referral for ECT in younger individuals are themselves associated with a high level of cognitive dysfunction. Furthermore, the prompt response of symptoms with ECT reduces the risk of suicide and minimizes disruptions to schooling and other critical areas of psychosocial functioning for children and adolescents.39
Use of ECT in individuals who are treatment resistant or require a rapid response
The FDA specifically requested comment on the clarity of the term “treatment resistant” and the phrase “require rapid response” in defining the population for which ECT benefits outweigh risks.40 The APA believes that the current wording is appropriate since there is no consensus on a “gold standard” rating scale to assess treatment resistance41 or on the most valid ways to identify treatment resistance in clinical contexts.42
In terms of a definition for “the need for a rapid response,” many factors could contribute to such a determination. A working definition is that the health and well-being of the individual is in acute danger of being compromised without an immediate intervention to treat their psychiatric disorder. A clinical decision about the use of ECT would need to consider the presence, magnitude and importance of relevant factors for the individual patient.
Special controls to assure safety and efficacy of ECT
The APA concurs with the FDA on the role of special controls to assure safe and effective use of ECT.
More specifically, we agree with the appropriateness of:
- Safety tests, software validation and electrical and mechanical performance data, using established technical parameters43
- Specific device use instructions, including pre-ECT assessment and monitoring during the procedure44
- Training of clinicians who will be administering ECT45
- Information on the intended patient population and typical course of treatment46
- Disclosure of contraindications, precautions, warnings and potential adverse effects/complications in physician and patient labelling47
Special controls related to potential cognitive effects of ECT
The FDA proposes a number of special controls related to potential cognitive effects of ECT. For some patients, cognitive function may be no worse, or even improved, when assessed across several cognitive domains at least two weeks after the end of ECT.48
However, in other individuals, demonstrable cognitive impairment occurs with ECT treatment. Thus, the APA concurs with the inclusion of information on assessing the possible cognitive effects of ECT as part of the device labelling and as an element of informed consent.
The APA also agrees with the importance of using validated screening instruments to monitor cognitive status prior to and during the ECT course, with more detailed cognitive testing obtained if clinically indicated. We suggest a particular focus on memory function, because memory deficits are most reported by patients and represent the primary form of cognitive deficit that is observed in research on cognition and ECT.
At the same time, some patients with severe psychiatric illness (e.g., major depressive episodes with psychosis, catatonia) may not be able to undertake even brief cognitive testing, especially before beginning ECT.
Although every effort should be made to conduct some assessment of cognition in all patients, no patient should be denied ECT treatment due to an inability to complete cognitive testing.
The APA does suggest several modifications to the wording in the proposed labelling.
Detailed formal neuropsychological assessment49 is not necessary in all patients treated with ECT and will not be possible in many treatment centers, resulting in a barrier to ECT treatment if this is required. Thus, the APA suggests that the phrase “formal neuropsychological assessment” be deleted from the labelling.
Instead, we recommend a staged approach to cognitive testing similar to what is used in other disorders in health care. Screening assessments covering orientation, attention, and memory in all patients prior to and during ECT would permit identification of those individuals who may require more detailed testing. Asking patients and family members about subjective concerns about cognition during the ECT course can also identify individuals who may require more detailed testing or adjustments in ECT treatment parameters.
The APA also proposes a change in the wording of the patient labeling50 so that it would read “The use of controlled electrical stimuli in modern ECT devices and adjustments in the way that ECT is given (such as alternative electrode placements and pulse parameters) can minimize but not completely eliminate these risks”. We advise against including a table (such as the one shown in the draft guidance51) that delineates the relationship between stimulation parameters and memory effects in the actual labelling. Adjustments in parameters such as treatment frequency and stimulus intensity often need to consider effects on cognition as well as effects of efficacy. In addition, recommendations on preferred treatment modalities may change as research evidence on ECT accrues.
Special controls related to ECT contraindications
In the discussion of labelling recommendations in the draft guidance, a number of conditions are listed as contraindications to ECT. The APA suggests that these conditions be described as “associated with substantially increased risk”52 rather than as a contraindication, per se. As with all medical decisions, clinical decisions about initiating treatment with ECT require weighing the possible benefits and risks of treatment against the possible benefits and risks of other treatment options or foregoing treatment.
In some circumstances, when a psychiatric condition is life-threatening, the potential benefits of ECT may still outweigh the risks of ECT in the presence of one of these conditions. Describing these conditions as contraindications is likely to restrict access to needed ECT in very rare but life-threatening situations.
Special controls for indications other than major depressive episodes
From a safety standpoint, as the FDA notes, ECT-related risks for major depressive episodes are comparable for catatonia, manic episodes (in bipolar disorder), schizophrenia, and schizoaffective disorder.53 Special controls as described for individuals with major depressive episodes would be able to mitigate the risks of ECT in these conditions.
For individuals under the age of 18, the APA suggests additional special controls that would support a change to a class II designation. Before proceeding with ECT, the APA recommends that the child or adolescent be evaluated by two independent psychiatrists with experience in treating youth of that age range as well as by the psychiatrist who will be performing ECT.
The purpose of these evaluations is to determine whether the child or adolescent has a diagnosis for which ECT is clinically indicated and whether additional trials of pharmacotherapy are indicated prior to initiating ECT as well as to determine the benefits and risks of ECT for the individual relative to other treatment options based upon the clinical circumstances.
Special controls in youth related to potential cognitive effects should parallel the recommendations in adults for specific assessment of orientation, attention, memory, and executive function using validated screening instruments with more detailed cognitive testing obtained if clinically indicated. Instruments should be designed for use in children or adolescents.
As with adults, every effort should be made to conduct some assessment of cognition in all patients. However, this may not be possible due to the severity of psychiatric symptoms or the patient’s level of baseline intellectual function, and no patient should be denied ECT treatment due to an inability to complete cognitive testing.
To assure safe delivery of anesthesia to children or adolescents who are being treated with ECT, the APA recommends that anesthesia providers be experienced in administering anesthesia to patients of a similar age.
Special controls related to long-term use of ECT
The FDA proposes a warning that “When used as intended this device provides short-term relief of symptoms. The long-term safety and effectiveness of ECT treatment has not been demonstrated.”54
The APA suggests that this warning not be included in the device labelling. ECT is not unique in having a substantial rate of symptom return if active treatment is stopped. However, similar warnings are not required with other devices or pharmacotherapies.
In addition, evidence from RCTs shows that symptom remission can be prolonged after an acute course of ECT if patients receive continuation/maintenance treatment with pharmacotherapy and/or ECT.55 In terms of long-term safety and effectiveness, there is a substantial body of evidence from case series,56 retrospective studies,57 clinical trials58 and systematic reviews59 on the safety and efficacy of continuation and maintenance ECT.
Most recently, in the National Institute of Mental Health (NIMH)-sponsored Prolonging Remission in Depressed Elderly (PRIDE) trial, geriatric depressed patients who had remitted with ECT and venlafaxine in the acute phase were randomly assigned to 6 months of treatment with either 1) venlafaxine and lithium (n=64) or 2) continuation ECT (4 treatments in the first month and additional ECT only if they began to relapse) plus lithium and venlafaxine (n=64).60
At the 6-month study endpoint, the Hamilton Rating Scale for Depression score (HRSD-24) of patients who received continuation ECT plus medication was significantly lower than that of patients in the medication-only group. In addition, the odds of being rated “not ill at all” on the Clinical Global Impression – Severity scale (CGI-S) were 5.2 times greater for the continuation ECT plus medication group compared with the medication-only group.
The odds of relapsing were 1.7 times higher for patients in the medication-only group compared to the continuation ECT plus medication group. These results confirm and extend the evidence for the long-term efficacy of ECT beyond 3 months.
In terms of the safety of ECT with longer-term use, well-designed studies that have assessed cognitive effects of continuation and maintenance ECT show no significant differences in cognitive outcomes in comparison with continuation pharmacotherapy.61
Thank you for your consideration of these comments on this important regulatory issue. We look forward to working with you in the future to develop and implement any policy changes related to ECT. In addition, we would be pleased to expand on any of the above comments. If you have any further questions, please contact Philip Wang, M.D., Dr.P.H., APA’s Director of Research, at [email protected]
Renée Binder, M.D. Saul Levin, M.D., M.P.A.
President CEO and Medical Director
- Federal Register Vol 80(249): 81227-81228
- Bjølseth TM, et al. Clinical efficacy of formula-based bifrontal versus right unilateral electroconvulsive therapy (ECT) in the treatment of major depression among elderly patients: a pragmatic, randomized, assessor-blinded, controlled trial. J Affect Disord. 175:8-17, 2015; Brakemeier EL, et al. Cognitive-behavioral therapy as continuation treatment to sustain response after electroconvulsive therapy in depression: a randomized controlled trial. Biol Psychiatry. 76(3):194-202, 2014; Quante A, et al. Effects of 3 different stimulus intensities of ultrabrief stimuli in right unilateral electroconvulsive therapy in major depression: a randomized, double-blind pilot study. J Psychiatr Res. 45(2):174-8, 2011; Semkovska M, et al. Bitemporal Versus High-Dose Unilateral Twice-Weekly Electroconvulsive Therapy for Depression (EFFECT-Dep): A Pragmatic, Randomized, Non-Inferiority Trial. Am J Psychiatry. (In press), 2016; Spaans HP, et al. Efficacy and cognitive side effects after brief pulse and ultrabrief pulse right unilateral electroconvulsive therapy for major depression: a randomized, double-blind, controlled study. J Clin Psychiatry. 74(11):e1029-36, 2013.
- McGrath PJ, et al. Tranylcypromine versus venlafaxine plus mirtazapine following three failed antidepressant medication trials for depression:
a STAR*D report. Am J Psychiatry. 163(9):1531-41,2006; Schoeyen HK, et al. Treatment-resistant bipolar depression: a randomized controlled trial of electroconvulsive therapy versus algorithm-based pharmacological treatment. Am J Psychiatry. 172(1):41-51, 2015.
- Dierckx B, et al. Efficacy of electroconvulsive therapy in bipolar versus unipolar major depression: a meta-analysis. Bipolar Disord. 14(2):14650, 2012
- Federal Register Vol 80(249): 81231, section C Risks to Health.
- Federal Register Vol 80(249): 81231
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- Federal Register Vol 80(249): 81228-81229; Federal Register Vol 80(249): 81232 § 882.5940 (b)(1)(i) through (b)(1)(vii); Draft guidance lines 62 through 317.
- Federal Register Vol 80(249): 81228-81229; Federal Register Vol 80(249): 81232 § 882.5940 (b)(1)(viii)(B)(1) through (b)(1)(viii)(B)(6).
- Federal Register Vol 80(249): 81228-81229; Federal Register Vol 80(249): 81232 § 882.5940 (b)(1)(viii)(C); Draft guidance lines 502-507.
- Federal Register Vol 80(249): 81228-81229; Federal Register Vol 80(249): 81232 § 882.5940 (b)(1)(viii)(D) through (b)(1)(viii)(E).
- Federal Register Vol 80(249): 81228-81229; Federal Register Vol 80(249): 81232 § 882.5940 (b)(1)(viii)(B); Federal Register Vol 80(249): 81233 § 882.5940 (b)(1)(ix)(A). 48 Bodnar A, et al. Electroconvulsive therapy and cognitive functions in treatment-resistant depression. World J Biol Psychiatry. 17(2): 1-6, 2015; Fernie G, et al. Detecting objective and subjective cognitive effects of electroconvulsive therapy: intensity, duration and test utility in a large clinical sample. Psychol Med. 44:2985-2994, 2014; Kirov GG, et al. Evaluation of cumulative cognitive deficits from electroconvulsive therapy. Br J Psychiatry. (In press), 2016; Semkovska M, McLoughlin DM. Objective cognitive performance associated with electroconvulsive therapy for depression: a systematic review and meta-analysis. Biol Psychiatry. 68:568-577, 2010.
- Federal Register, Vol 80(249): 81232 § 882.5940 (b)(1)(viii)(B)(7), Draft guidance lines 461-472
- Federal Register Vol 80(249): 81233 § 882.5940 (b)(1)(ix)(H)(1); Draft guidance lines 394-400 and 564-565.
- Draft guidance lines 366-367.
- The Practice of Electroconvulsive Therapy: Recommendations for Treatment, Training, and Privileging: A Task Force Report of the American Psychiatric Association, 2nd ed., Washington, D.C.: American Psychiatric Association, 2001.
- Federal Register Vol 80(249): 81231, section C Risks to Health.
- Federal Register Vol 80(249): 81229; Federal Register Vol 80(249): 81233 § 882.5940 (b)(1)(viii)(J) and (b)(1)(ix)(G); Draft guidance lines 594595
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