Back to resultsGuanfacine for the Treatment of Post Traumatic Stress Disorder (PTSD)
Primary Purpose
Post-Traumatic Stress Disorder
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
guanfacine
Sponsored by
About this trial
This is an interventional treatment trial for Post-Traumatic Stress Disorder focused on measuring PTSD
Eligibility Criteria
Males and females, age 18-65 Diagnosis of PTSD from combat or civilian trauma No major medical problems such as diabetes, cardiovascular disease Taking no psychiatric medication, or taking only one SSRI antidepressant
Sites / Locations
- VA Connecticut Healthcare System
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00018603
First Posted
July 3, 2001
Last Updated
January 20, 2009
Sponsor
US Department of Veterans Affairs
1. Study Identification
Unique Protocol Identification Number
NCT00018603
Brief Title
Guanfacine for the Treatment of Post Traumatic Stress Disorder (PTSD)
Official Title
Guanfacine for the Treatment of PTSD
Study Type
Interventional
2. Study Status
Record Verification Date
December 2004
Overall Recruitment Status
Completed
Study Start Date
November 1999 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2002 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
US Department of Veterans Affairs
4. Oversight
5. Study Description
Brief Summary
This is a double-blind, placebo-controlled, randomized study lasting 8 weeks. Purpose of the study is two-fold: first, to use a pharmacological agent to treat symptoms of PTSD, and second, to explore neurobiological mechanisms of action of guanfacine.
Detailed Description
Subject population is comprised of 100 persons with PTSD. 50 patients will receive guanfacine and 50 patients will receive a placebo. Guanfacine is prescribed at 1 mg/day and may be increased to 2 mg/day. Samples of plasma MHPG will be collected weekly. Clinical ratings of PTSD anxiety and depression, as well as vital signs, will be assessed weekly. Repeated measures analysis of variance will assess significance of main effect of drug, time, and drug by time.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Traumatic Stress Disorder
Keywords
PTSD
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
guanfacine
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Males and females, age 18-65
Diagnosis of PTSD from combat or civilian trauma
No major medical problems such as diabetes, cardiovascular disease
Taking no psychiatric medication, or taking only one SSRI antidepressant
Facility Information:
Facility Name
VA Connecticut Healthcare System
City
West Haven
State/Province
Connecticut
ZIP/Postal Code
06516
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Guanfacine for the Treatment of Post Traumatic Stress Disorder (PTSD)
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