Status:
COMPLETED
Prazosin vs. Paroxetine in Combat Stress Symptoms in OIF/OEF Returnees
Lead Sponsor:
US Department of Veterans Affairs
Conditions:
Sleep Disorders
Stress Disorders, Post-Traumatic
Eligibility:
All Genders
18-50 years
Phase:
NA
Brief Summary
Evaluate the efficacy and tolerability of the drug prazosin compared to placebo for combat stress-related nightmares, sleep disturbance and overall function in recently combat-exposed returnees from O...
Detailed Description
Trauma-related nightmares and sleep disruption that follow combat exposure are distressing and frequently treatment resistant symptoms that impair quality of life and overall function. These symptoms ...
Eligibility Criteria
Inclusion
- Hazardous duty in Iraq or Afghanistan with the US Armed Forces during Operations Iraqi Freedom and Operation Enduring Freedom
- Exposure to at least a moderate level of combat (\>5 on Revised Combat Exposure Scale)
- Good general medical health
- Stable dose of non-excluded medications for at least 4 weeks prior to randomization
- \>5 on CAPS recurrent distressing dreams item
- \>5 on CAPS difficulty falling or staying asleep item
Exclusion
- Acute or significant chronic medical illness, preexisting hypotension or orthostatic hypotension, pancreatitis, gout, M ni re's disease, benign positional vertigo, narcolepsy, or any other unstable medical condition.
- Women of childbearing potential with either positive pregnancy test or refusal to use effective birth control method will be excluded.
- Lifetime schizophrenia, schizoaffective disorder, bipolar disorder, psychotic disorder or any DSM-IV cognitive disorder, current delirium, substance dependence disorder within 3 months of the study, 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.
- Allergy or previous adverse reaction to prazosin or other alpha-1 antagonist or paroxetine or any other SSRI, no concurrent use of another alpha-1 antagonist agent, no concurrent use an antidepressant (other than trazodone prescribed for sleep).
Key Trial Info
Start Date :
July 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2009
Estimated Enrollment :
210 Patients enrolled
Trial Details
Trial ID
NCT00261729
Start Date
July 1 2004
End Date
December 1 2009
Last Update
December 3 2009
Active Locations (1)
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1
VA Puget Sound Health Care System, Seattle
Seattle, Washington, United States, 98108