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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00178061
Other study ID # 970843-0109
Secondary ID 970843-0109
Status Completed
Phase Phase 4
First received September 13, 2005
Last updated June 21, 2013
Start date August 1997
Est. completion date August 2002

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 13
Est. completion date August 2002
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria:

- Bipolar I Disorder with Comorbid Borderline Personality Disorder, currently manic or depressed

Exclusion Criteria:

- Unstable Medical illness

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Behavioral:
Interpersonal Social Rhythm Therapy (IPSRT)


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 Hamilton Rating Scale for Depression (HRSD-25)
Secondary Raskin Severity of Depression and Mania Scales
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