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

NCT00000375 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2005-12-20

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Nortriptyline-lithium (NOR-Li)

PROCEDURE

Bilateral electroconvulsive therapy (ECT)

DRUG

Continuation therapy

BEHAVIORAL

Continuation ECT

Sponsors & Collaborators

  • National Institute of Mental Health (NIMH)

    lead NIH

Principal Investigators

  • Charles Kellner, MD

  • Mustafa Husain, MD

  • Teresa Rummans, MD

  • George Petrides

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1997-02-28

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00000375 on ClinicalTrials.gov