Prazosin vs. Paroxetine in Combat Stress Symptoms in OIF/OEF Returnees

Completed · Not applicable · Has a placebo group

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

In brief

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 OIF and OEF. To evaluate the effects of the SSRI paroxetine on behavioral symptoms and overall function in this population.

Key facts

Study ID

NCT00261729

Run by

US Department of Veterans Affairs

People needed

210

Starts

2004-07-01

Expected to finish

2009-12-01

Last updated by the study team

2009-12-03

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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).

Where it is running

• VA Puget Sound Health Care System, Seattle — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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