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Comparing Various Treatments for Achieving and Maintaining Remission of Depression

Primary Purpose

Depression

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Imipramine
Interpersonal Psychotherapy
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring Major depression

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Western Psychiatric Institute and Cinic

Outcomes

Primary Outcome Measures

Time to recurrence of depression symptoms

Secondary Outcome Measures

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

Full Information

First Posted
September 26, 2005
Last Updated
June 21, 2013
Sponsor
University of Pittsburgh
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1. Study Identification

Unique Protocol Identification Number
NCT00227955
Brief Title
Comparing Various Treatments for Achieving and Maintaining Remission of Depression
Official Title
Maintenance Therapies in Recurrent Depression-Study I
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
December 1987 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 1993 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University of Pittsburgh

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Major depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Imipramine
Intervention Type
Behavioral
Intervention Name(s)
Interpersonal Psychotherapy
Primary Outcome Measure Information:
Title
Time to recurrence of depression symptoms
Secondary Outcome Measure Information:
Title
Measured at Months 7, 11, and 36: Score on the Raskin Depression and Mania Severity Scales

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ellen Frank, PhD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
Western Psychiatric Institute and Cinic
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States

12. IPD Sharing Statement

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Comparing Various Treatments for Achieving and Maintaining Remission of Depression

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