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...
Date First Received: July 3, 2001
Last Updated: January 20, 2009
Verified by: Department of Veterans Affairs, December 2004
Clinical Trial Phase: Phase 1 | Start Date: November 1999
Overall Status: Completed
Brief Summary
Official Title: “Guanfacine for the Treatment of PTSD”
Condition Keyword(s):
Intervention(s):
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.
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Detailed Clinical Trial 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.
Intervention(s) in this Clinical Trial
- Drug: guanfacine
Criteria for Participation in this Clinical Trial
- 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
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: 65 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Department of Veterans Affairs
Additional Information
Information obtained from ClinicalTrials.gov on February 04, 2010
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00018603
Study ID Number: MHBS-047-99F
ClinicalTrials.gov Identifier: NCT00018603
Health Authority: United States: Federal Government
Clinical Trials Authorship and Review
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