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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00018603
First Posted: July 5, 2001
Last Update Posted: January 21, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
VA Office of Research and Development
  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 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Guanfacine for the Treatment of PTSD

Resource links provided by NLM:


Further study details as provided by VA Office of Research and Development:

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00018603


Locations
United States, Connecticut
VA Connecticut Healthcare System
West Haven, Connecticut, United States, 06516
Sponsors and Collaborators
VA Office of Research and Development
  More Information

ClinicalTrials.gov Identifier: NCT00018603     History of Changes
Other Study ID Numbers: MHBS-047-99F
First Submitted: July 3, 2001
First Posted: July 5, 2001
Last Update Posted: January 21, 2009
Last Verified: December 2004

Keywords provided by VA Office of Research and Development:
PTSD

Additional relevant MeSH terms:
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders
Guanfacine
Antihypertensive Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs