Status:
COMPLETED
Prazosin Treatment for Combat Trauma PTSD (Post-Traumatic Stress Disorder) Nightmares and Sleep Disturbance
Lead Sponsor:
US Department of Veterans Affairs
Conditions:
Stress Disorder, Post-Traumatic
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to determine whether prazosin will reduce the incidence of nightmares, sleep disturbance, and overall symptoms in combat trauma-exposed individuals with PTSD.
Detailed Description
The combat stress-related nightmares and sleep disturbance that often follow exposure to military combat are distressing and frequently persistent symptoms that impair quality of life and both occupat...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Combat-trauma exposed persons with a diagnosis of PTSD
- No diagnosis of lifetime schizophrenia, schizoaffective disorder, bipolar disorder, psychotic disorder, or any DSM-IV cognitive disorder; current delirium, or substance dependence disorder within 3 months of the study or current substance use other than alcohol (no more than 2 drinks/day); severe psychiatric instability or situational life crises, including evidence of being actively suicidal or homicidal, or any behavior which poses an immediate danger to patient or others
- In good general medical health (no acute or significant chronic medical illness, including unstable angina, recent myocardial infarction, history of congestive heart failure, preexisting hypotension \[systolic \<110\] or orthostatic hypotension \[systolic drop \> 20 mmHg after two minutes standing or any drop with dizziness\]; insulin-dependent diabetes mellitus; chronic renal or hepatic failure, pancreatitis, gout, Meniere's disease, benign positional vertigo, narcolepsy, allergy or previous adverse reaction to prazosin or other alpha-1 antagonist, or any unstable medical condition).
- Stable dose of nonexcluded medications for concurrent stable medical conditions for at least 4 weeks prior to randomization.
- Specific criteria used to validate presence of combat stress-related nightmares and sleep disturbance will include: score \> 5 (of a maximum score of 8) on the CAPS Recurrent Distressing Dreams item. (CAPS score \>5 places subjects in the upper third of nightmare severity) or score \> 5 (of a maximum score of 8) on the CAPS Difficulty Falling or Staying Asleep item.
Exclusion
Key Trial Info
Start Date :
October 1 2003
Trial Type :
INTERVENTIONAL
End Date :
March 1 2007
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00108420
Start Date
October 1 2003
End Date
March 1 2007
Last Update
January 21 2009
Active Locations (1)
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1
VA Puget Sound Health Care System
Seattle, Washington, United States, 98108