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Continuation Electroconvulsive Therapy Vs Medication to Prevent Relapses in Patients With Major Depressive Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00000375
Recruitment Status : Completed
First Posted : November 3, 1999
Last Update Posted : December 20, 2005
Information provided by:
National Institute of Mental Health (NIMH)

Brief Summary:

The purpose of this study is to compare the safety and effectiveness of two treatments to prevent relapses in seriously ill patients with major depressive disorder (MDD) who have responded to electroconvulsive therapy (ECT). Patients will either continue to receive ECT (continuation electroconvulsive therapy [C-ECT]), or they will be treated with antidepressant medications.

ECT is a highly effective treatment for MDD; however, relapses are a major concern. To prevent relapse in patients who have responded to ECT, the common treatment is antidepressants as continuation therapy (following the initial therapy in order to continue treating the disorder). Relapses, however, can still occur even after antidepressant continuation therapy. This study will evaluate a potent antidepressant combination in order to prevent relapse. C-ECT is another option that needs to be tested.

If the patient responds to the first round of ECT, he/she will be assigned randomly (like tossing a coin) to either continue receiving ECT or to receive an antidepressant combination of nortriptyline plus lithium (NOR-Li) for 6 months. The patient will have psychological tests before, shortly after, and 3 months after the first round of ECT, and at the end of the 6-month continuation trial. Patients will be monitored for symptoms and side effects. All patients will have urine tests to test for drug abuse.

An individual may be eligible for this study if he/she:

Has major depressive disorder and responds positively to ECT treatment and is 18 to 80 years old.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Drug: Nortriptyline-lithium (NOR-Li) Procedure: Bilateral electroconvulsive therapy (ECT) Drug: Continuation therapy Behavioral: Continuation ECT Phase 4

Detailed Description:

To define the role of continuation electroconvulsive therapy (C-ECT) in relapse-prevention of seriously ill patients with major depressive disorder (MDD). To determine the relative efficacy and safety of C-ECT in comparison to the traditional approach of continuation pharmacotherapy (C-PHARM) to prevent relapses of MDD.

Electroconvulsive therapy (ECT) is a highly effective treatment for MDD that is helpful for patients with the most severe forms of affective illness; however, relapse after successful acute phase ECT or pharmacotherapy remains a major public health problem. To prevent relapse in patients with MDD who have responded to ECT, the common practice is to prescribe an antidepressant (e.g., a tricyclic [TCA], a selective serotonin reuptake inhibitor [SSRI], or lithium) as continuation therapy. Recent studies show an alarmingly high relapse rate after ECT despite conventional continuation pharmacotherapy (C-PHARM). Continuation ECT (C-ECT) is also in widespread clinical use; however, its efficacy and safety have never been rigorously tested.

Investigators at four sites (Mayo Clinic, UMDNJ-New Jersey Medical School, Zucker Hillside Hospital, and University of Texas SW Medical Center, Dallas) randomize patients to receive either C-ECT or an aggressive pharmacological strategy (nortriptyline and lithium in combination, [NOR-Li]) for 6 months following response to acute phase ECT. Raters at each site evaluate symptoms and side effects. On the basis of edited videotapes obtained at regular intervals, a site-independent, blinded evaluator also assesses symptoms. A neuropsychological battery is administered prior to acute phase ECT, shortly after the ECT course, 3 months after the end of the acute phase treatment, and at the end of the 6-month continuation trial. These continuation therapies are compared in their effects on relapse, cognitive performance, global functioning, side effects, and perceived health status. NOR and Li levels are optimized by blood level monitoring. Bilateral ECT, at progressively increasing intervals, are used for C-ECT. Methods are included to ensure the integrity of clinical diagnoses, symptom severity assessment, data collection and entry, and treatment delivery. In all patients, surreptitious use of prescription or recreational drugs is monitored by urine testing.

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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Masking: Single
Primary Purpose: Treatment
Official Title: Continuation ECT Vs Pharmacotherapy--Efficacy And Safety
Study Start Date : February 1997

Resource links provided by the National Library of Medicine

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:


Patients must have:

Major depressive disorder that is responsive to acute phase ECT.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00000375

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United States, New Jersey
New Jersey Medical School
Newark, New Jersey, United States, 07103
Sponsors and Collaborators
National Institute of Mental Health (NIMH)
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Study Chair: Charles Kellner, MD
Principal Investigator: Mustafa Husain, MD
Principal Investigator: Teresa Rummans, MD
Principal Investigator: George Petrides
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00000375    
Obsolete Identifiers: NCT00069394
Other Study ID Numbers: MH55495
First Posted: November 3, 1999    Key Record Dates
Last Update Posted: December 20, 2005
Last Verified: December 2005
Keywords provided by National Institute of Mental Health (NIMH):
Antidepressive Agents
Depressive Disorder
Electroconvulsive Therapy
Serotonin Uptake Inhibitors
Antidepressive Agents -- *therapeutic use
Antidepressive Agents -- adverse effects
Lithium -- *therapeutic use
Lithium -- adverse effects
Nortriptyline -- *therapeutic use
Nortriptyline -- adverse effects
Additional relevant MeSH terms:
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Depressive Disorder
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Antidepressive Agents
Psychotropic Drugs
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antidepressive Agents, Tricyclic
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Adrenergic Agents
Neurotransmitter Agents