View Clinical Trial (Medical Research Study)

Augmentation Trial of Prazosin for Post-Traumatic Stress Disorder (PTSD) - NCT00990106-98431(Clinical Trial 368319)



ClinicalConnection.com has recently undergone an update and this page may no longer be up-to-date. Please Search For Clinical Trials to view the most current clinical trials listings.


Signup
City:  Tacoma
State:  
WA
Zip Code: 98431
Conditions: Stress Disorders, Post-Traumatic - Combat Disorders - Sleep Disorders
Purpose: 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 OIF/OEF veterans.
Study summary: 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 PTSD trauma-related nightmares, sleep disturbance, global function and sense of well-being, and other clinical features and comorbidities of PTSD. Participants will be 210 OIF/OEF soldiers and veterans who have suffered war zone trauma. Participants will be randomized 1:1 to prazosin or placebo and all previous psychotropic medications and/or psychotherapy will be maintained constant. Randomization will be stratified by site and use of an antidepressant.
Criteria: 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.
Study is available at: Madigan Army Medical Center
Tacoma, WA 98431
United States

Primary Contact:
Tammy Williams, MSW
Email: tammy.williams10@us.army.mil
Phone: 253-968-4735

Secondary Contact:
Hollie Holmes, BA
Email: Hollie.Holmes@va.gov
Phone: 206-277-6207
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
Trials Alerts: If you would like to be notified of new clinical trials as they become available please register for a free account.
Data Source: ClinicalTrials.gov
Date Processed: March 23, 2011
Modifications to
this listing:		 Only selected fields are shown, please use the link above to view all information about this clinical trial.