Comparing Various Treatments for Achieving and Maintaining Remission of Depression

Depression Clinical Trial

Official title:

Maintenance Therapies in Recurrent Depression-Study I

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00227955
• Other study ID #: 871250
• Status: Completed
• Phase: Phase 4
• First received: September 26, 2005
• Last updated: June 21, 2013
• Start date: December 1987
• Est. completion date: December 1993

Study information

• Verified date: June 2013
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

This study will evaluate the effectiveness of five combinations of drug therapy and psychotherapy in maintaining remission of depression symptoms in people with recurrent major depression.

Description:

Depression is a serious illness that can interfere with a person's ability to work, study, sleep, eat, and enjoy activities that once were pleasurable. It is characterized by several symptoms, such as the following: persistent sad, anxious, or "empty" mood; feelings of hopelessness or pessimism; and feelings of guilt, worthlessness, or helplessness. If left untreated, depression symptoms can last for years, and may worsen as time goes on. Even with treatment, however, it is possible for depression to recur. Remission is a main goal in the treatment of depression and it may be accomplished through various strategies. This study will evaluate the effectiveness of five combinations of treatments, including medication therapy and psychotherapy, in maintaining remission of depression symptoms.

All participants in this study will first be treated with imipramine for 7 to 11 months. Once remission of depression symptoms has been achieved and maintained for 20 weeks, participants will be randomly assigned to one of the following five maintenance treatments for 36 months: psychotherapy plus imipramine; psychotherapy plus placebo; psychotherapy alone; medication clinic treatment plus imipramine; or medication clinic treatment plus placebo. Assessments will be made at Weeks 12 and 20 and Months 7, 11, and 36, and will include the time it takes for depression symptoms to recur, as well as scores on depression and mania severity scales.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: December 1993
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 65 Years

Eligibility

Inclusion Criteria:

• Diagnosis of recurrent major depression

Exclusion Criteria:

• Unstable medical illness

• Any other simultaneous psychiatric or medical illness of greater concern than depression (index episode of depression is not primary)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Drug:
• Imipramine

Behavioral:
• Interpersonal Psychotherapy

Locations

Country	Name	City	State
United States	Western Psychiatric Institute and Cinic	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to recurrence of depression symptoms
Secondary	Measured at Months 7, 11, and 36: Score on the Raskin Depression and Mania Severity Scales