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

This study has been completed.

First Received: July 3, 2001 Last Updated: January 20, 2009 History of Changes

Sponsor:	Department of Veterans Affairs
Information provided by:	Department of Veterans Affairs
ClinicalTrials.gov Identifier:	NCT00018603

Purpose

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.

Condition	Intervention	Phase
Post-Traumatic Stress Disorder	Drug: guanfacine	Phase I

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Guanfacine for the Treatment of PTSD

Resource links provided by NLM:

MedlinePlus related topics: Post-Traumatic Stress Disorder

Drug Information available for: Guanfacine Guanfacine hydrochloride

U.S. FDA Resources

Further study details as provided by Department of Veterans Affairs:

Study Start Date:	November 1999
Estimated Study Completion Date:	October 2002

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.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00018603

Locations

United States, Connecticut
VA Connecticut Healthcare System
West Haven, Connecticut, United States, 06516

Sponsors and Collaborators

Department of Veterans Affairs

More Information

No publications provided

Study ID Numbers:	MHBS-047-99F
Study First Received:	July 3, 2001
Last Updated:	January 20, 2009
ClinicalTrials.gov Identifier:	NCT00018603 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by Department of Veterans Affairs:

PTSD

Additional relevant MeSH terms:

Neurotransmitter Agents
Disease
Adrenergic alpha-Agonists
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Physiological Effects of Drugs
Stress
Cardiovascular Agents
Antihypertensive Agents

Adrenergic Agonists
Stress Disorders, Traumatic
Pharmacologic Actions
Pathologic Processes
Anxiety Disorders
Mental Disorders
Guanfacine
Therapeutic Uses
Stress Disorders, Post-Traumatic

ClinicalTrials.gov processed this record on November 27, 2009