Effective Measurement of Risperidone Treatment Outcome for Persons With Borderline Personality Disorder

This study has been completed.
Sponsor:
Collaborator:
Janssen Pharmaceutica N.V., Belgium
Information provided by (Responsible Party):
Bobbie May, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT00204347
First received: September 13, 2005
Last updated: March 15, 2012
Last verified: March 2012
  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)

Resource links provided by NLM:


Further study details as provided by University of Alabama at Birmingham:

Primary Outcome Measures:
  • Clinical Global Impression
  • Brief Symptom Inventory

Secondary Outcome Measures:
  • 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)
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.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00204347

Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35205
Sponsors and Collaborators
University of Alabama at Birmingham
Janssen Pharmaceutica N.V., Belgium
Investigators
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:
Borderline Personality Disorder
Disease
Personality Disorders
Mental Disorders
Pathologic Processes
Risperidone
Antipsychotic Agents
Central Nervous System Agents
Central Nervous System Depressants
Dopamine Agents
Dopamine Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Antagonists
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on October 22, 2014