Borderline Personality Disorder
Conditions
Keywords
risperidone
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.
Interventions
DRUGrisperidone
Sponsors
Janssen Pharmaceutica
University of Alabama at Birmingham
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
19 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical Global Impression | — |
| Brief Symptom Inventory | — |
Secondary
| Measure | Time frame |
|---|---|
| Beck Depression Inventory | — |
| Quality of Life Enjoyment and Satisfaction Questionnaire | — |
Countries
United States
Outcome results
None listed