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

NCT00000375 | Completed Phase 4

• 1 other identifier: MH55495
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder

Keywords

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

Interventions

Nortriptyline-lithium (NOR-Li) DRUG

Bilateral electroconvulsive therapy (ECT) PROCEDURE

Continuation therapy DRUG

Continuation ECT BEHAVIORAL

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have:
• Major depressive disorder that is responsive to acute phase ECT.

Sponsors & Collaborators

• National Institute of Mental Health (NIMH): lead

Study Sites (1)

New Jersey Medical School

Newark, New Jersey, 07103, United States

Location

Related Publications (1)

• Husain MM, McClintock SM, Rush AJ, Knapp RG, Fink M, Rummans TA, Rasmussen K, Claassen C, Petrides G, Biggs MM, Mueller M, Sampson S, Bailine SH, Lisanby SH, Kellner CH. The efficacy of acute electroconvulsive therapy in atypical depression. J Clin Psychiatry. 2008 Mar;69(3):406-11. doi: 10.4088/jcp.v69n0310.

  PMID: 18278988 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major; Depressive Disorder

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders

Study Officials

• Charles Kellner, MD

  STUDY CHAIR

• Mustafa Husain, MD

  PRINCIPAL INVESTIGATOR

• Teresa Rummans, MD

  PRINCIPAL INVESTIGATOR

• George Petrides

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: November 2, 1999
• First Posted: November 3, 1999
• Study Start: February 1, 1997
• Last Updated: December 20, 2005

Record last verified: 2005-12

Locations

US (1)