Effects of Comorbid Personality Disorder on the Treatment... | NCT00178061

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

NCT00178061

Sponsor

University of Pittsburgh

Status

Completed

Last Update Posted

Jun 25, 2013Estimated

Enrollment

Phase

Phase 4

Conditions

Bipolar I Disorder
Borderline Personality Disorder

Interventions

Interpersonal Social Rhythm Therapy (IPSRT)

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
970843-0109

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

Aug 1997

Primary Completion Date

Not provided

Completion Date

Aug 2002

First Submitted Date

Sep 13, 2005

First Submission Date that Met QC Criteria

Sep 13, 2005

First Posted Date

Sep 15, 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

Description Module

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.

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

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
Interpersonal Social Rhythm Therapy (IPSRT)	Behavioral

Measure	Description	Time Frame
Hamilton Rating Scale for Depression (HRSD-25)

Measure	Description	Time Frame
Raskin Severity of Depression and Mania Scales

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Unstable Medical illness

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 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	University of Pittsburgh	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Western Psychiatric Institute and Clinic		Pittsburgh	Pennsylvania	15213	United States

Condition Browse Module

MeSH Terms

ID	Term
D001883	Borderline Personality Disorder

Ancestor Terms

ID	Term
D010554	Personality Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided