Expired Study
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Birmingham, Alabama 35205


The objective of Study A is to evaluate the efficacy of risperidone on the 4 behavioral dimensions of Berderline Personality Disorder (BPD)in an open label trial:mood swings, impulsivity, thing difficulties and disturbed relationships. The secondary objective of this study (Study B)is to validate a self-report measure of clinical symptoms specific to the treatment of patients with BPD, the UAB Borderline Rating Scale(BRS).

Study summary:

Study A: An open-label, prospective trial of the efficacy and safety of risperidone in the treatment of BPD.The study is 8 weeks in duration, with a screening visit and follow-up visits at the end of Weeks 1,2,3,4,6, and 8. 20 female patients, 19 years or older will be recruited. A full medical and psychiatric history will be taken and a physical exam will be performed by a sstudy physician. A psychosocial assessment will be conducted during the screen. Study B: The ofjective is to validate the UAB BRS by administering the BRS and other neuropsychological instruments as repeated measures over a 6 week period to 40 patients with BPD.


Inclusion Criteria: - Diagnosis of BPD Exclusion Criteria: - Any other Axis I diagnosis except dysthymia, PTSD, or generalized anxiety disorder;substance abuse within a month; unstable medical illness.

Study is Available At:

Original ID:




Secondary ID:

Study Acronym:

Brief Title:

Effective Measurement of Risperidone Treatment Outcome for Persons With Borderline Personality Disorder

Official Title:

Effective Measurement of Risperidone Treatment Outcome for Persons With Borderline Personality Disorder: The UAB Borderline Rating Scale (BRS)

Overall Status:


Study Phase:

Phase 4



Minimum Age:

19 Years

Maximum Age:


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Alabama at Birmingham

Oversight Authority:

United States: Institutional Review Board

Reasons Why Stopped:

Study Type:


Study Design:

Allocation: Non-Randomized, Endpoint Classificati

Number of Arms:


Number of Groups:


Total Enrollment:


Enrollment Type:

Overall Contact Information

Official Name:Celia T. Huston, PhD
Principal Investigator
University of Alabama at Birmingham

Study Dates

Start Date:July 2003
Completion Date:October 2007
Completion Type:Actual
Primary Completion Date:October 2007
Primary Completion Type:Actual
Verification Date:March 2012
Last Changed Date:March 15, 2012
First Received Date:September 13, 2005

Study Outcomes

Outcome Type:Primary Outcome
Measure:Clinical Global Impression
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Brief Symptom Inventory
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Beck Depression Inventory
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Quality of Life Enjoyment and Satisfaction Questionnaire
Safety Issues:False

Study Interventions

Intervention Type:Drug

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Alabama at Birmingham
Agency Class:Industry
Agency Type:Collaborator
Agency Name:Janssen Pharmaceutica N.V., Belgium

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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