Maintenance Interpersonal Psychotherapy for Sustaining Remission of Depression
Primary Purpose
Depression
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Interpersonal Psychotherapy
Fluoxetine
Sponsored by

About this trial
This is an interventional treatment trial for Depression focused on measuring Depression Relapse, Maintenance Therapy
Eligibility Criteria
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
Sites / Locations
- Western Psychiatric Institute and Clinic
Outcomes
Primary Outcome Measures
Score on the Hamilton Rating Scale for Depression (measured at Month 24)
Secondary Outcome Measures
Score on the Beck Depression Inventory
Score on the Global Assessment of Functioning (measured at Month 24)
Full Information
NCT ID
NCT00227981
First Posted
September 26, 2005
Last Updated
June 21, 2013
Sponsor
University of Pittsburgh
1. Study Identification
Unique Protocol Identification Number
NCT00227981
Brief Title
Maintenance Interpersonal Psychotherapy for Sustaining Remission of Depression
Official Title
Maintenance Psychotherapies in Recurrent Depression: Study II
Study Type
Interventional
2. Study Status
Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
March 1995 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2001 (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 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Depression Relapse, Maintenance Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
93 (false)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Interpersonal Psychotherapy
Intervention Type
Drug
Intervention Name(s)
Fluoxetine
Primary Outcome Measure Information:
Title
Score on the Hamilton Rating Scale for Depression (measured at Month 24)
Secondary Outcome Measure Information:
Title
Score on the Beck Depression Inventory
Title
Score on the Global Assessment of Functioning (measured at Month 24)
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
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 Clinic
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15237
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
18781665
Citation
Dombrovski AY, Cyranowski JM, Mulsant BH, Houck PR, Buysse DJ, Andreescu C, Thase ME, Mallinger AG, Frank E. Which symptoms predict recurrence of depression in women treated with maintenance interpersonal psychotherapy? Depress Anxiety. 2008;25(12):1060-6. doi: 10.1002/da.20467.
Results Reference
derived
PubMed Identifier
17475735
Citation
Frank E, Kupfer DJ, Buysse DJ, Swartz HA, Pilkonis PA, Houck PR, Rucci P, Novick DM, Grochocinski VJ, Stapf DM. Randomized trial of weekly, twice-monthly, and monthly interpersonal psychotherapy as maintenance treatment for women with recurrent depression. Am J Psychiatry. 2007 May;164(5):761-7. doi: 10.1176/ajp.2007.164.5.761.
Results Reference
derived
Learn more about this trial
Maintenance Interpersonal Psychotherapy for Sustaining Remission of Depression
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