Maintenance Interpersonal Psychotherapy for Sustaining Re... | NCT00227981

Studies
Maintenance Interpersonal Psychotherapy for Sustaining Remission of Depression

NCT00227981

Sponsor

University of Pittsburgh

Status

Completed

Last Update Posted

Jun 25, 2013Estimated

Enrollment

Phase

Not Applicable

Conditions

Depression

Interventions

Interpersonal Psychotherapy
Fluoxetine

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
DSIR 950309-9905

Status Module

Record Verification Date

Jun 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1995

Primary Completion Date

Not provided

Completion Date

Mar 2001

First Submitted Date

Sep 26, 2005

First Submission Date that Met QC Criteria

Sep 26, 2005

First Posted Date

Sep 28, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 21, 2013

Last Update Posted Date

Jun 25, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

University of PittsburghOTHER

Collaborators

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Score on the Hamilton Rating Scale for Depression (measured at Month 24)

Secondary Outcomes

Measure	Description	Time Frame
Score on the Beck Depression Inventory
Score on the Global Assessment of Functioning (measured at Month 24)

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ellen Frank, PhD	University of Pittsburgh	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Western Psychiatric Institute and Clinic		Pittsburgh	Pennsylvania	15237	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
18781665	Derived	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.
17475735	Derived	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.

ID	Term
D001526	Behavioral Symptoms
D001519	Behavior

ID	Term
D011613	Psychotherapy
D004191	Behavioral Disciplines and Activities
D011437	Propylamines
D000588	Amines

ID	Term
D000079062	Interpersonal Psychotherapy
D005473	Fluoxetine