Guanfacine for the Treatment of Post Traumatic Stress Disorder (PTSD)

Phase 1

Completed

• Conditions: Post-Traumatic Stress Disorder

• Registration Number: NCT00018603
• Lead Sponsor: US Department of Veterans Affairs

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.

Study Timeline

• Study Start: 1999-11
• Study First Submitted: 2001-07-03
• Study First Submitted QC: 2001-07-04
• Study First Posted: 2001-07-05
• Study Completion: 2002-10
• Status Verified: 2004-12
• Last Update Submitted: 2009-01-20
• Last Update Posted: 2009-01-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Trial Locations

Locations (1)

VA Connecticut Healthcare System; 🇺🇸 West Haven, Connecticut, United States