Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Birmingham, Alabama 35205


Purpose:

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.


Criteria:

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:

RIS-DED-WTJ


NCT ID:

NCT00204347


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:

Completed


Study Phase:

Phase 4


Genders:

Female


Minimum Age:

19 Years


Maximum Age:

N/A


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:

Interventional


Study Design:

Allocation: Non-Randomized, Endpoint Classificati


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

20


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
Name:risperidone

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

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


This study is not currently recruiting Study Participants. The form below is not enabled.