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NCT00000375 · ClinicalTrials.gov registry record · Phase 4

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

A Phase 4 study, sponsored by National Institute of Mental Health (NIMH).

Completed
Registry status
Phase 4
Development phase

NCT00000375 is a Phase 4 study that has completed, run by National Institute of Mental Health (NIMH).

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The verdict

NCT00000375, a Phase 4 study, has completed, sponsored by National Institute of Mental Health (NIMH).

COMPLETED
Registry status
Phase 4
Development phase

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.

Interventions

  • DRUG Nortriptyline-lithium (NOR-Li)
  • PROCEDURE Bilateral electroconvulsive therapy (ECT)
  • DRUG Continuation therapy
  • BEHAVIORAL Continuation ECT

Trial Details

FieldValue
Start Date 1997-02
Phase Phase 4

What the Registry Record Tells You About NCT00000375

The ClinicalTrials.gov registry entry for NCT00000375 describes a study currently listed as completed, categorized as Phase 4. An enrollment target was not published in the registry record, which is common for early-stage or observational entries. The listed sponsor is National Institute of Mental Health (NIMH), which has 343 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 4 interventions - of which Nortriptyline-lithium (NOR-Li) is the first listed.

NCT00000375 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00000375 about?

NCT00000375 is a clinical study titled "Continuation Electroconvulsive Therapy Vs Medication to Prevent Relapses in Patients With Major Depressive Disorder". 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 electroconvulsiv...

What is the current status of trial NCT00000375?

This trial is currently completed. It is a Phase 4 study. The study started on 1997-02.

What interventions are being tested in trial NCT00000375?

The interventions under investigation include: Nortriptyline-lithium (NOR-Li) (DRUG), Bilateral electroconvulsive therapy (ECT) (PROCEDURE), Continuation therapy (DRUG), Continuation ECT (BEHAVIORAL).

Who is sponsoring clinical trial NCT00000375?

This trial is sponsored by National Institute of Mental Health (NIMH), which has 343 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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