Status:
COMPLETED
Augmentation Trial of Prazosin for Post-Traumatic Stress Disorder (PTSD)
Lead Sponsor:
Seattle Institute for Biomedical and Clinical Research
Collaborating Sponsors:
United States Department of Defense
VA Puget Sound Health Care System
Conditions:
Stress Disorders, Post-Traumatic
Combat Disorders
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to determine whether prazosin will: * reduce the incidence of nightmares and sleep disturbance * increase functioning and sense of well being in combat-trauma exposed Ope...
Detailed Description
This is a 15-week randomized parallel design, double-blind, placebo-controlled augmentation trial of prazosin to evaluate the efficacy and tolerability of prazosin augmentation in the treatment of PTS...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Age \>18 years;
- Clear evidence of exposure to one or more war zone trauma events sufficient to satisfy DSM-IV criterion A1 for diagnosis of PTSD;
- DSM-IV diagnosis of PTSD derived from the CAPS; CAPS total score \>50;
- CAPS Recurrent Distressing Dreams item score \>5 (of maximum score of 8);
- stable dose of non-exclusionary medications and psychotherapeutic treatment for at least 4 weeks prior to randomization;
- good general medical health.
- Female participants must agree to use a reliable form of birth control during the study.
- Exclusion Criteria
- Psychiatric/Behavioral - meets DSM-IV criteria for current schizophrenia, schizoaffective disorder, psychotic disorder, delirium, or any DSM-IV cognitive disorder; substance dependence disorder within 3 months or any current substance dependence; current cocaine or stimulant abuse; severe psychiatric instability or severe situational life crises, including evidence of being actively suicidal or homicidal, or any behavior which poses an immediate danger to patient or others.
- Medical - acute or unstable chronic medical illness, including unstable angina, recent myocardial infarction (within 6 months), congestive heart failure, preexisting hypotension or orthostatic hypotension, chronic renal or hepatic failure, pancreatitis, Meniere's disease, benign positional vertigo; narcolepsy, or diagnosed sleep apnea; allergy or previous adverse reaction to prazosin or other alpha-1 antagonist.
Exclusion
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
67 Patients enrolled
Trial Details
Trial ID
NCT00990106
Start Date
September 1 2009
End Date
March 1 2013
Last Update
May 23 2018
Active Locations (2)
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1
VA Puget Sound Health Care System
Seattle, Washington, United States, 98108
2
Madigan Army Medical Center
Tacoma, Washington, United States, 98431