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Comparing Various Treatments for Achieving and Maintaining Remission of Depression

This study has been completed.
Sponsor:
Information provided by:
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00227955
First received: September 26, 2005
Last updated: June 21, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention Phase
Depression
Drug: Imipramine
Behavioral: Interpersonal Psychotherapy
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Maintenance Therapies in Recurrent Depression-Study I

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

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

Estimated Enrollment: 200
Study Start Date: December 1987
Estimated Study Completion Date: December 1993
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.

  Eligibility

Ages Eligible for Study:   21 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00227955

Locations
United States, Pennsylvania
Western Psychiatric Institute and Cinic
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Ellen Frank, PhD University of Pittsburgh
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00227955     History of Changes
Other Study ID Numbers: 871250
Study First Received: September 26, 2005
Last Updated: June 21, 2013
Health Authority: United States: Federal Government

Keywords provided by University of Pittsburgh:
Major depression

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mental Disorders
Mood Disorders

ClinicalTrials.gov processed this record on November 24, 2014