Effective Measurement of Risperidone Treatment Outcome for Persons With Borderline Personality Disorder
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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).
| Condition | Intervention | Phase |
|---|---|---|
|
Borderline Personality Disorder |
Drug: risperidone |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Effective Measurement of Risperidone Treatment Outcome for Persons With Borderline Personality Disorder: The UAB Borderline Rating Scale (BRS) |
- Clinical Global Impression
- Brief Symptom Inventory
- Beck Depression Inventory
- Quality of Life Enjoyment and Satisfaction Questionnaire
| Estimated Enrollment: | 20 |
| Study Start Date: | July 2003 |
| Study Completion Date: | October 2007 |
| Primary Completion Date: | October 2007 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 19 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
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.
Contacts and Locations| United States, Alabama | |
| University of Alabama at Birmingham | |
| Birmingham, Alabama, United States, 35205 | |
| Principal Investigator: | Celia T. Huston, PhD | University of Alabama at Birmingham |
More Information
No publications provided
| Responsible Party: | Bobbie May, Asst. Professor, University of Alabama at Birmingham |
| ClinicalTrials.gov Identifier: | NCT00204347 History of Changes |
| Other Study ID Numbers: | RIS-DED-WTJ |
| Study First Received: | September 13, 2005 |
| Last Updated: | March 15, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Alabama at Birmingham:
|
risperidone |
Additional relevant MeSH terms:
|
Personality Disorders Borderline Personality Disorder Mental Disorders Risperidone Serotonin Antagonists Serotonin Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
Physiological Effects of Drugs Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Central Nervous System Agents Therapeutic Uses Psychotropic Drugs Dopamine Antagonists Dopamine Agents |
ClinicalTrials.gov processed this record on May 19, 2013