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Comparing Various Treatments for Achieving and Maintaining Remission of Depression

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00227955
Recruitment Status : Completed
First Posted : September 28, 2005
Last Update Posted : June 25, 2013
Information provided by:
University of Pittsburgh

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.

Condition or disease Intervention/treatment Phase
Depression Drug: Imipramine Behavioral: Interpersonal Psychotherapy Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Maintenance Therapies in Recurrent Depression-Study I
Study Start Date : December 1987
Study Completion Date : December 1993

Resource links provided by the National Library of Medicine

Drug Information available for: Imipramine

Primary Outcome Measures :
  1. Time to recurrence of depression symptoms

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00227955

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United States, Pennsylvania
Western Psychiatric Institute and Cinic
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
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Principal Investigator: Ellen Frank, PhD University of Pittsburgh
Layout table for additonal information Identifier: NCT00227955    
Other Study ID Numbers: 871250
First Posted: September 28, 2005    Key Record Dates
Last Update Posted: June 25, 2013
Last Verified: June 2013
Keywords provided by University of Pittsburgh:
Major depression
Additional relevant MeSH terms:
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Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Antidepressive Agents, Tricyclic
Antidepressive Agents
Psychotropic Drugs
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs