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NCT00018603 Clinical Trial

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

Post-Traumatic Stress Disorder Clinical Trial

Official title:
Guanfacine for the Treatment of PTSD

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00018603
Other study ID # MHBS-047-99F
Secondary ID
Status Completed
Phase Phase 1
First received July 3, 2001
Last updated January 20, 2009
Start date November 1999
Est. completion date October 2002

Study information
Verified date December 2004
Source VA Office of Research and Development
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date October 2002
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility - 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• guanfacine

Locations
Country Name City State
United States VA Connecticut Healthcare System West Haven Connecticut

Sponsors (1)
Lead Sponsor Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

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