Effective Measurement of Risperidone Treatment Outcome for Persons With Borderline Personality Disorder - Full Text View

Sponsors and Collaborators:	University of Alabama at Birmingham Janssen Pharmaceutica N.V., Belgium
Information provided by:	University of Alabama at Birmingham
ClinicalTrials.gov Identifier:	NCT00204347

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 IV

MedlinePlus related topics: Personality Disorders

Drug Information available for: Risperidone

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Effective Measurement of Risperidone Treatment Outcome for Persons With Borderline Personality Disorder: The UAB Borderline Rating Scale (BRS)

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
Estimated Study Completion Date:	October 2007

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

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

Study ID Numbers:	RIS-DED-WTJ
Study First Received:	September 13, 2005
Last Updated:	February 13, 2008
ClinicalTrials.gov Identifier:	NCT00204347
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Alabama at Birmingham:

risperidone

Study placed in the following topic categories:

Dopamine
Mental Disorders
Risperidone

Borderline Personality Disorder
Serotonin
Personality Disorders

Additional relevant MeSH terms:

Neurotransmitter Agents
Disease
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants
Dopamine Antagonists

Antipsychotic Agents
Pharmacologic Actions
Serotonin Antagonists
Pathologic Processes
Serotonin Agents
Therapeutic Uses
Dopamine Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009