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Completed

NCT Number: NCT00227955

Comparing Various Treatments for Achieving and Maintaining Remission of Depression

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.

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Key information

Conditions

Depression Behavior Behavioral Symptoms Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Western Psychiatric Institute and Cinic

Pittsburgh, Pennsylvania, 15213, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Imipramine

Drug

interpersonal psychotherapy

Behavioral

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

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Registry information

Official study title

Maintenance Therapies in Recurrent Depression-Study I

Important dates

Study start
1987
Study completion
1993
First posted
Sep 28, 2005
Registry last updated
Jun 25, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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