Prazosin vs Paroxetine in Combat Stress-Related Post-Traumatic Stress Disorder (PTSD) Nightmares & Sleep Disturbance

• Status: Terminated
• Trial end date: 2008-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The purposes of this study are:

• to 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 Operation Iraqi Freedom (OIF) and Operation Enduring Freedom (OEF).

• to evaluate the effects of the selective serotonin reuptake inhibitor (SSRI) paroxetine on behavioral symptoms and overall function in this population.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seattle Institute for Biomedical and Clinical Research
• Collaborators: United States Department of Defense; VA Puget Sound Health Care System
• Treatments: Paroxetine; Prazosin

Criteria

Inclusion Criteria:

• 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 Criteria:

• Acute or significant chronic medical illness, preexisting hypotension or orthostatic hypotension, pancreatitis, gout, Ménière'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 Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (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 of an antidepressant (other than trazodone prescribed for sleep).