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

This study has been completed.
Sponsor:
Information provided by:
National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:
NCT00000375
First received: November 2, 1999
Last updated: December 19, 2005
Last verified: December 2005
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Single Blind
Primary Purpose: Treatment
Official Title: Continuation ECT Vs Pharmacotherapy--Efficacy And Safety

Resource links provided by NLM:


Further study details as provided by National Institute of Mental Health (NIMH):

Study Start Date: February 1997
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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

-

Patients must have:

Major depressive disorder that is responsive to acute phase ECT.

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000375

Locations
United States, New Jersey
New Jersey Medical School
Newark, New Jersey, United States, 07103
Sponsors and Collaborators
Investigators
Study Chair: Charles Kellner, MD
Principal Investigator: Mustafa Husain, MD
Principal Investigator: Teresa Rummans, MD
Principal Investigator: George Petrides
  More Information

No publications provided by National Institute of Mental Health (NIMH)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00000375     History of Changes
Obsolete Identifiers: NCT00069394
Other Study ID Numbers: MH55495
Study First Received: November 2, 1999
Last Updated: December 19, 2005
Health Authority: United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):
Adult
Antidepressive Agents
Depressive Disorder
Electroconvulsive Therapy
Female
Human
Lithium
Male
Nortriptyline
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:
Depression
Depressive Disorder
Depressive Disorder, Major
Disease
Behavioral Symptoms
Mental Disorders
Mood Disorders
Pathologic Processes
Antidepressive Agents
Lithium
Nortriptyline
Therapeutic Uses
Adrenergic Agents
Adrenergic Uptake Inhibitors
Antidepressive Agents, Tricyclic
Antimanic Agents
Antipsychotic Agents
Central Nervous System Agents
Central Nervous System Depressants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Tranquilizing Agents

ClinicalTrials.gov processed this record on October 23, 2014