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Comparing Various Treatments for Achieving and Maintaining Remission of Depression

Maintenance Therapies in Recurrent Depression-Study I

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00227955
Enrollment
200
Registered
2005-09-28
Start date
1987-12-31
Completion date
1993-12-31
Last updated
2013-06-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression

Keywords

Major depression

Brief 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.

Detailed 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.

Interventions

DRUGImipramine
BEHAVIORALInterpersonal Psychotherapy

Sponsors

University of Pittsburgh
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frame
Time to recurrence of depression symptoms

Secondary

MeasureTime frame
Measured at Months 7, 11, and 36: Score on the Raskin Depression and Mania Severity Scales

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026