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Effects of Comorbid Personality Disorder on the Treatment of Bipolar I Disorder

Primary Purpose

Bipolar I Disorder, Borderline Personality Disorder

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Interpersonal Social Rhythm Therapy (IPSRT)

About this trial

This is an interventional treatment trial for Bipolar I Disorder

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Bipolar I Disorder with Comorbid Borderline Personality Disorder, currently manic or depressed Exclusion Criteria: Unstable Medical illness

Sites / Locations

Western Psychiatric Institute and Clinic

Outcomes

Primary Outcome Measures

Hamilton Rating Scale for Depression (HRSD-25)

Secondary Outcome Measures

Raskin Severity of Depression and Mania Scales

Full Information

NCT ID

NCT00178061

First Posted

September 13, 2005

Last Updated

June 21, 2013

Sponsor

University of Pittsburgh

1. Study Identification

Unique Protocol Identification Number

NCT00178061

Brief Title

Effects of Comorbid Personality Disorder on the Treatment of Bipolar I Disorder

Official Title

Treatment of Primary Mood Disorders in the Comorbidly Ill

Study Type

Interventional

2. Study Status

Record Verification Date

June 2013

Overall Recruitment Status

Completed

Study Start Date

August 1997 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

August 2002 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

University of Pittsburgh

4. Oversight

5. Study Description

Brief Summary

This study will examine the impact of comorbid personality disorder on the outcome of treatment among patients with bipolar I disorder.

Detailed Description

The major aim of this proposal is to examine the impact of comorbid personality disorder on the outcome of treatment among patients with bipolar I disorder. The specific aims are to create a research and supervisory team and to identify potential moderators of treatment response and mediators of outcome over the course of treatment. Members of the team will meet weekly to begin a treatment development process for enhancing Interpersonal Social Rhythm Therapy (IPSRT) for these patients. Additional assessment measures will be utilized to examine the proposed mediators and moderators of treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Bipolar I Disorder, Borderline Personality Disorder

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

13 (false)

8. Arms, Groups, and Interventions

Intervention Type

Behavioral

Intervention Name(s)

Interpersonal Social Rhythm Therapy (IPSRT)

Primary Outcome Measure Information:

Title

Hamilton Rating Scale for Depression (HRSD-25)

Secondary Outcome Measure Information:

Title

Raskin Severity of Depression and Mania Scales

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Bipolar I Disorder with Comorbid Borderline Personality Disorder, currently manic or depressed Exclusion Criteria: Unstable Medical illness

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ellen Frank

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

15213

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Effects of Comorbid Personality Disorder on the Treatment of Bipolar I Disorder

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