Effective Measurement of Risperidone Treatment Outcome for Persons With Borderline Personality Disorder
Primary Purpose
Borderline Personality Disorder
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
risperidone
Sponsored by
About this trial
This is an interventional treatment trial for Borderline Personality Disorder focused on measuring risperidone
Eligibility 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.
Sites / Locations
- University of Alabama at Birmingham
Outcomes
Primary Outcome Measures
Clinical Global Impression
Brief Symptom Inventory
Secondary Outcome Measures
Beck Depression Inventory
Quality of Life Enjoyment and Satisfaction Questionnaire
Full Information
NCT ID
NCT00204347
First Posted
September 13, 2005
Last Updated
June 8, 2021
Sponsor
University of Alabama at Birmingham
Collaborators
Janssen Pharmaceutica
1. Study Identification
Unique Protocol Identification Number
NCT00204347
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)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
July 2003 (undefined)
Primary Completion Date
October 2007 (Actual)
Study Completion Date
October 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
Collaborators
Janssen Pharmaceutica
4. Oversight
5. Study Description
Brief Summary
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).
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Borderline Personality Disorder
Keywords
risperidone
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
risperidone
Primary Outcome Measure Information:
Title
Clinical Global Impression
Title
Brief Symptom Inventory
Secondary Outcome Measure Information:
Title
Beck Depression Inventory
Title
Quality of Life Enjoyment and Satisfaction Questionnaire
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Celia T. Huston, PhD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Effective Measurement of Risperidone Treatment Outcome for Persons With Borderline Personality Disorder
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