Ignite Creation Date:
2024-05-05 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00204347
Status:
COMPLETED
Last Update Posted:
2021-06-10
First Post:
2005-09-13
Brief Title:
Effective Measurement of Risperidone Treatment Outcome for Persons With Borderline Personality Disorder
Sponsor:
University of Alabama at Birmingham
Organization:
University of Alabama at Birmingham
Study Overview
Official Title:
Effective Measurement of Risperidone Treatment Outcome for Persons With Borderline Personality Disorder The UAB Borderline Rating Scale BRS
Status:
COMPLETED
Status Verified Date:
2021-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objective of Study A is to evaluate the efficacy of risperidone on the 4 behavioral dimensions of Berderline Personality Disorder BPDin an open label trialmood swings impulsivity thing difficulties and disturbed relationships The secondary objective of this study Study Bis to validate a self-report measure of clinical symptoms specific to the treatment of patients with BPD the UAB Borderline Rating ScaleBRS
Detailed Description:
Study A An open-label prospective trial of the efficacy and safety of risperidone in the treatment of BPDThe study is 8 weeks in duration with a screening visit and follow-up visits at the end of Weeks 12346 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None