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Maintenance Interpersonal Psychotherapy for Sustaining 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: NCT00227981
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 maintenance interpersonal psychotherapy (IPT) in preventing relapse of depression in women who have required combined psychotherapy and pharmacotherapy treatment to obtain a remission of depression symptoms.

Condition or disease Intervention/treatment Phase
Depression Behavioral: Interpersonal Psychotherapy Drug: Fluoxetine Not Applicable

Detailed Description:

Depression is a serious medical illness that can recur more than once in a person's lifetime. Effective treatment methods are needed to maintain a state of remission in people who have had prior episodes of depression. IPT is a brief and highly structured type of psychotherapy that addresses interpersonal issues associated with depression. Previous studies have shown that it is an effective method for treating depression. This study will evaluate the effectiveness of maintenance ITP in preventing relapse of depression in women who have required combined psychotherapy and pharmacotherapy treatment to obtain remission of depressive symptoms.

Participants in this open label study will be recruited from a previous study, "Maintenance Psychotherapy in Recurrent Depression: Study I." In this study participants will initially receive weekly sessions of IPT as well as medication treatment with fluoxetine. Any participants who do not reach remission of depressive symptoms after 6 weeks will be given other standard treatments for depression. Once remission of depressive symptoms is reached, participants will continue receiving weekly IPT and fluoxetine treatment for 20 weeks. After 20 weeks, fluoxetine treatment will be discontinued, and all participants will receive IPT alone for 6 weeks before entering the maintenance phase of the study. Upon entrance into this phase, participants will be randomly assigned to receive IPT weekly, biweekly, or monthly for 18 months. Functioning and depressive symptoms will be assessed at Month 24.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 93 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Maintenance Psychotherapies in Recurrent Depression: Study II
Study Start Date : March 1995
Study Completion Date : March 2001

Resource links provided by the National Library of Medicine

Drug Information available for: Fluoxetine

Primary Outcome Measures :
  1. Score on the Hamilton Rating Scale for Depression (measured at Month 24)

Secondary Outcome Measures :
  1. Score on the Beck Depression Inventory
  2. Score on the Global Assessment of Functioning (measured at Month 24)

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:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Met all entry criteria for the parent study, "Maintenance Psychotherapy in Recurrent Depression, Study I"
  • Began IPT as outlined in the parent study
  • Demostrated compliance with IPT sessions during the parent study
  • Exhibits less than a 50% reduction in score on the Hamilton Rating Scale for Depression after 12 weeks of psychotherapy or fails to meet stabilization criteria after 24 weeks of psychotherapy during the parent study

Exclusion Criteria:

  • Any unstable medical illness

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): NCT00227981

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United States, Pennsylvania
Western Psychiatric Institute and Clinic
Pittsburgh, Pennsylvania, United States, 15237
Sponsors and Collaborators
University of Pittsburgh
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Principal Investigator: Ellen Frank, PhD University of Pittsburgh
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00227981    
Other Study ID Numbers: R01MH049115 ( U.S. NIH Grant/Contract )
DSIR 950309-9905
First Posted: September 28, 2005    Key Record Dates
Last Update Posted: June 25, 2013
Last Verified: June 2013
Keywords provided by University of Pittsburgh:
Depression Relapse
Maintenance Therapy
Additional relevant MeSH terms:
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Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors