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NCT00358969 Clinical Trial

Guanfacine to Treat Borderline Personality Disorder

Borderline Personality Disorder Clinical Trial

Official title:
Guanfacine in the Treatment of Borderline Personality Disorder

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00358969
Other study ID # GCO 06-0518
Secondary ID
Status Recruiting
Phase N/A
First received July 31, 2006
Last updated July 31, 2006
Start date July 2006

Study information
Verified date July 2006
Source Bronx VA Medical Center
Contact Emily Hart
Phone (212) 241-4459
Email mpgroup@mssm.edu
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 55 Years
Eligibility 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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• guanfacine (Tenex)

Locations
Country Name City State
United States Mount Sinai Hospital - Mood & Personality Research Group New York New York

Sponsors (1)
Lead Sponsor Collaborator
Icahn School of Medicine at Mount Sinai

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary measures of impulsive aggression
Primary measures of affective disturbance
Primary measures of social and occupational functioning
Primary measures of overall clinical status
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