NCT00227981

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
93

participants targeted

Target at P50-P75 for not_applicable depression

Timeline
Completed

Started Mar 1995

Longer than P75 for not_applicable depression

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 1995

Completed
6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2001

Completed
4.6 years until next milestone

First Submitted

Initial submission to the registry

September 26, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 28, 2005

Completed
Last Updated

June 25, 2013

Status Verified

June 1, 2013

First QC Date

September 26, 2005

Last Update Submit

June 21, 2013

Conditions

Depression

Keywords

Depression RelapseMaintenance Therapy

Outcome Measures

Primary Outcomes (1)

  • Score on the Hamilton Rating Scale for Depression (measured at Month 24)

Secondary Outcomes (2)

  • Score on the Beck Depression Inventory

  • Score on the Global Assessment of Functioning (measured at Month 24)

Interventions

Interpersonal PsychotherapyBEHAVIORAL
FluoxetineDRUG

Eligibility Criteria

Age20 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Any unstable medical illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Western Psychiatric Institute and Clinic

Pittsburgh, Pennsylvania, 15237, United States

Location

Related Publications (2)

  • 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.

    PMID: 18781665DERIVED

  • 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.

    PMID: 17475735DERIVED

MeSH Terms

Conditions

Depression

Interventions

Interpersonal PsychotherapyFluoxetine

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and ActivitiesPropylaminesAminesOrganic Chemicals

Study Officials

  • Ellen Frank, PhD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 26, 2005

First Posted

September 28, 2005

Study Start

March 1, 1995

Study Completion

March 1, 2001

Last Updated

June 25, 2013

Record last verified: 2013-06

Locations

US(1)