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Guanfacine to Treat Borderline Personality Disorder

Primary Purpose

Borderline Personality Disorder

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
guanfacine (Tenex)
Sponsored by
Icahn School of Medicine at Mount Sinai
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Borderline Personality Disorder focused on measuring borderline personality disorder, guanfacine, impulsivity, aggression, affective instability

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Mount Sinai Hospital - Mood & Personality Research GroupRecruiting

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
July 31, 2006
Last Updated
July 31, 2006
Sponsor
Icahn School of Medicine at Mount Sinai
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1. Study Identification

Unique Protocol Identification Number
NCT00358969
Brief Title
Guanfacine to Treat Borderline Personality Disorder
Official Title
Guanfacine in the Treatment of Borderline Personality Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
July 2006
Overall Recruitment Status
Unknown status
Study Start Date
July 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Icahn School of Medicine at Mount Sinai

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Borderline Personality Disorder
Keywords
borderline personality disorder, guanfacine, impulsivity, aggression, affective instability

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Non-Randomized

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
guanfacine (Tenex)
Primary Outcome Measure Information:
Title
measures of impulsive aggression
Title
measures of affective disturbance
Title
measures of social and occupational functioning
Title
measures of overall clinical status

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Emily Hart
Phone
(212) 241-4459
Email
mpgroup@mssm.edu
First Name & Middle Initial & Last Name or Official Title & Degree
David Meyerson
Phone
(212) 241-9734
Email
david.meyerson@mssm.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antonia S. New, M.D.
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mount Sinai Hospital - Mood & Personality Research Group
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

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Guanfacine to Treat Borderline Personality Disorder

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