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CompletedNCT00227955Updated Jun 25, 2013

Comparing Various Treatments for Achieving and Maintaining Remission of Depression

A Phase 4 interventional study of Imipramine and Interpersonal Psychotherapy in Depression, sponsored by University of Pittsburgh. Completed at 1 site in United States. Open to participants aged 21 Years to 65 Years. Per ClinicalTrials.gov, last updated 2013-06-25.

Sponsored by University of Pittsburgh · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
21 Years to 65 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Depression

Keywords

  • Major depression
03

In context

Depression

8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.

This study's enrollment of 200 is above the median of 84 across 6,720 interventional studies indexed under Depression.

Browse Depression studies →

Lead sponsor

University of Pittsburgh is the lead sponsor of 1,385 studies on the registry; 167 are open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 4 (50%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Diagnosis of recurrent major depression

Exclusion criteria

Exclusion Criteria:

  • Unstable medical illness
  • Any other simultaneous psychiatric or medical illness of greater concern than depression (index episode of depression is not primary)
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
200 participants

Interventions

  • DrugImipramine
  • BehavioralInterpersonal Psychotherapy
06

What researchers measure

Primary outcomes

  1. Time to recurrence of depression symptoms

Secondary outcomes

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

07

Study locations

1 site
  • Western Psychiatric Institute and Cinic
    Pittsburgh, Pennsylvania 15213, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 25, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00227955
Lead sponsor
University of Pittsburgh
First posted
Sep 28, 2005
Start date
Dec 1987
Completion
Dec 1993
Last update
Jun 25, 2013

Study contacts

Ellen Frank, PhD
principal investigator · University of Pittsburgh
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2013. You cannot join it, but the record below documents what was studied.

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