Maintenance Interpersonal Psychotherapy for Sustaining Remission of Depression

Depression Clinical Trial

Official title:

Maintenance Psychotherapies in Recurrent Depression: Study II

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00227981
• Other study ID #: R01MH049115
• Secondary ID: DSIR 950309-9905
• Status: Completed
• Phase: N/A
• First received: September 26, 2005
• Last updated: June 21, 2013
• Start date: March 1995
• Est. completion date: March 2001

Study information

• Verified date: June 2013
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 93
• Est. completion date: March 2001
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Behavioral:
• Interpersonal Psychotherapy

Drug:
• Fluoxetine

Locations

Country	Name	City	State
United States	Western Psychiatric Institute and Clinic	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Score on the Hamilton Rating Scale for Depression (measured at Month 24)
Secondary	Score on the Beck Depression Inventory
Secondary	Score on the Global Assessment of Functioning (measured at Month 24)