Guanfacine to Treat Borderline Personality Disorder

• ClinicalTrials.gov Identifier: NCT00358969
• Recruitment Status: Unknown
• First Posted: August 1, 2006
• Last Update Posted: August 1, 2006
• Sponsor: Icahn School of Medicine at Mount Sinai
• Information provided by: Bronx VA Medical Center

Tracking Information

• First Submitted Date: July 31, 2006
• First Posted Date: August 1, 2006
• Last Update Posted Date: August 1, 2006
• Study Start Date: July 2006
• Primary Completion Date: Not Provided

Current Primary Outcome Measures (submitted: July 31, 2006)

• measures of impulsive aggression
• measures of affective disturbance
• measures of social and occupational functioning
• measures of overall clinical status

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Guanfacine to Treat Borderline Personality Disorder
• Official Title: Guanfacine in the Treatment of Borderline Personality Disorder
• 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.
• 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 Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: Double; Primary Purpose: Treatment
• Condition: Borderline Personality Disorder
• Intervention: Drug: guanfacine (Tenex)
• Study Arms: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Enrollment: Not Provided
• Original Enrollment: Not Provided
• Study Completion Date: Not Provided
• Primary Completion Date: Not Provided

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 55 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00358969
• Other Study ID Numbers: GCO 06-0518
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Not Provided
• Study Sponsor: Icahn School of Medicine at Mount Sinai
• Collaborators: Not Provided

Investigators

• Principal Investigator: Antonia S. New, M.D.; Icahn School of Medicine at Mount Sinai

• PRS Account: Bronx VA Medical Center
• Verification Date: July 2006