- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00018603
Guanfacine for the Treatment of Post Traumatic Stress Disorder (PTSD)
January 20, 2009 updated by: US Department of Veterans Affairs
Guanfacine for the Treatment of PTSD
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Connecticut
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West Haven, Connecticut, United States, 06516
- VA Connecticut Healthcare System
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 63 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
- 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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 1999
Study Completion
October 1, 2002
Study Registration Dates
First Submitted
July 3, 2001
First Submitted That Met QC Criteria
July 4, 2001
First Posted (Estimate)
July 5, 2001
Study Record Updates
Last Update Posted (Estimate)
January 21, 2009
Last Update Submitted That Met QC Criteria
January 20, 2009
Last Verified
December 1, 2004
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Trauma and Stressor Related Disorders
- Stress Disorders, Traumatic
- Stress Disorders, Post-Traumatic
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Antihypertensive Agents
- Adrenergic alpha-2 Receptor Agonists
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Guanfacine
Other Study ID Numbers
- MHBS-047-99F
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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