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Predictors of Treatment Response to Fluoxetine in PTSD Following a Recent History of War Zone Stress Exposure
Annual rept. 1 Jul 2011-30 Jun 2012
TEMPVA RESEARCH GROUP INC TEMPLE TX
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Although selective serotonin reuptake inhibitors SSRIs are routinely prescribed for acute stress disorder and early PTSD and recommended in the VA-DoD best practice guidelines, the efficacy of SSRIs as an early intervention for PTSD in service members returning from war-zone duty has still not been determined. Consequently, this study was designed to conduct a controlled trial of fluoxetine as an early intervention for recently redeployed soldiers, as well as to develop methodologies for understanding the multiple factors that may predict outcome. The Brooke Army Medical Center IRB, the regional IRB for the Carl R. Darnall Army Medical Center, has given full approval. A CRADA between TEMPVA Research Group, Inc and the Carl R. Darnall Army Medical Center has been executed. Human Research Protection Office HRPO Office of Research Protections ORP U.S. Army Medical Research and Materiel Command USAMRMC Fort Detrick has been completed and full approval has been given for enrollment. Continuing review was approved in April 2011. 40 participants have been enrolled and recruitment continues. A second performance site, the Central Texas Veterans Health Care System, was added to aid recruitment. A no-cost extension has been requested until June 30, 2013.
APPROVED FOR PUBLIC RELEASE