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Guanfacine to Treat Borderline Personality Disorder

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ClinicalTrials.gov Identifier: NCT00358969
Recruitment Status : Unknown
Verified July 2006 by Bronx VA Medical Center.
Recruitment status was:  Recruiting
First Posted : August 1, 2006
Last Update Posted : August 1, 2006
Sponsor:
Information provided by:
Bronx VA Medical Center

Study Description
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Brief Summary:
This study is designed to investigate whether guanfacine (Tenex) is an effective treatment for borderline personality disorder (BPD), an illness often characterized by unstable mood and impulsive aggression. Guanfacine stimulates activity in the front portion of the brain, a region associated with attention and the control of behavior. We believe that guanfacine may improve symptoms of BPD by improving attention and aiding regulation of behavior.

Condition or disease Intervention/treatment Phase
Borderline Personality Disorder Drug: guanfacine (Tenex) Not Applicable

Detailed Description:
This is an 8-week treatment study designed to test whether guanfacine is an effective treatment for borderline personality disorder (BPD). Prior to taking the study medication, subjects will have medical and psychiatric evaluations, complete self-report questionnaires, do a functional MRI scan, and complete a set of cognitive tests. While taking the study medication, participants will meet weekly with a study doctor and be administered interviews and questionnaires. At the end of the 8-week trial, participants will be asked to repeat the MRI scan and cognitive tests.

Study Design
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Study Type : Interventional  (Clinical Trial)
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Guanfacine in the Treatment of Borderline Personality Disorder
Study Start Date : July 2006

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Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. measures of impulsive aggression
  2. measures of affective disturbance
  3. measures of social and occupational functioning
  4. measures of overall clinical status

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: This study includes men and women between the ages of 18 and 55 who meet criteria for borderline personality disorder with impulsive aggression.

Exclusion Criteria: Subjects must not currently be taking any psychiatric medications. Subjects must not meet criteria for current substance dependence, current major depression, bipolar disorder, or schizophrenia-spectrum disorders.

Contacts and Locations
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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): NCT00358969


Contacts
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Contact: Emily Hart (212) 241-4459 mpgroup@mssm.edu
Contact: David Meyerson (212) 241-9734 david.meyerson@mssm.edu

Locations
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United States, New York
Mount Sinai Hospital - Mood & Personality Research Group Recruiting
New York, New York, United States, 10029
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
Investigators
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Principal Investigator: Antonia S. New, M.D. Icahn School of Medicine at Mount Sinai
More Information
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ClinicalTrials.gov Identifier: NCT00358969     History of Changes
Other Study ID Numbers: GCO 06-0518
First Posted: August 1, 2006    Key Record Dates
Last Update Posted: August 1, 2006
Last Verified: July 2006

Keywords provided by Bronx VA Medical Center:
borderline personality disorder
guanfacine
impulsivity
aggression
affective instability

Additional relevant MeSH terms:
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Disease
Personality Disorders
Borderline Personality Disorder
Pathologic Processes
Mental Disorders
Guanfacine
Antihypertensive Agents
 Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs