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

This study has been completed.
Sponsor:
Information provided by:
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00018603
First received: July 3, 2001
Last updated: January 20, 2009
Last verified: December 2004
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Guanfacine for the Treatment of PTSD

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
  More Information

No publications provided

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

Keywords provided by Department of Veterans Affairs:
PTSD

Additional relevant MeSH terms:
Disease
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders
Pathologic Processes
Guanfacine
Adrenergic Agents
Adrenergic Agonists
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Antihypertensive Agents
Cardiovascular Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014