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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00204347
First Posted: September 20, 2005
Last Update Posted: March 16, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Janssen Pharmaceutica N.V., Belgium
Information provided by (Responsible Party):
Bobbie May, University of Alabama at Birmingham
  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
Intervention Model: Single Group Assignment
Masking: None (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 Bobbie May, 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

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: September 13, 2005
First Posted: September 20, 2005
Last Update Posted: March 16, 2012
Last Verified: March 2012

Keywords provided by Bobbie May, University of Alabama at Birmingham:
risperidone

Additional relevant MeSH terms:
Disease
Personality Disorders
Borderline Personality Disorder
Pathologic Processes
Mental Disorders
Risperidone
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents