Augmentation Trial of Prazosin for Post-Traumatic Stress Disorder (PTSD)

Completed · Not applicable · Has a placebo group

Conditions studied: Stress Disorders, Post-Traumatic, Combat Disorders, Sleep Disorders

In brief

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 Operation Iraqi Freedom/Operation Enduring Freedom (OIF/OEF) Veterans.

Key facts

Study ID

NCT00990106

Run by

Seattle Institute for Biomedical and Clinical Research

People needed

67

Starts

2009-09-01

Expected to finish

2013-03-01

Last updated by the study team

2018-05-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• VA Puget Sound Health Care System — Seattle, Washington, United States
• Madigan Army Medical Center — Tacoma, Washington, United States

Full record on ClinicalTrials.gov

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