Prazosin Treatment for Combat Trauma PTSD (Post-Traumatic Stress Disorder) Nightmares and Sleep Disturbance

• Status: Completed
• Trial end date: 2007-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: US Department of Veterans Affairs; VA Office of Research and Development
• Treatments: Prazosin

Criteria

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.