Predictors of Treatment Response to Fluoxetine in PTSD Following a Recent History of War Zone Stress Exposure
Status:
Unknown status
Trial end date:
2012-08-01
Target enrollment:
Participant gender:
Summary
Three hundred (300) male or female outpatients, over 18 years of age, will be enrolled in
this study to determine whether fluoxetine can be used as a treatment for Posttraumatic
Stress Disorder in soldiers recently returning from combat exposure. There will be two phases
to the study. In Phase I Fluoxetine + usual psychological care will be compared with Placebo
+ usual psychological care over a 12-week period. Subsequently, in Phase II all subjects will
be offered the opportunity to enroll in a 20-week open-label trial on Fluoxetine. If response
is inadequate, adjunctive treatment with either buspirone or bupropion will be offered. The
investigational drugs are Fluoxetine, Buspirone and Bupropion. All are commercially
available.
Phase:
Phase 4
Details
Lead Sponsor:
TEMPVA Research Group, Inc.
Collaborators:
C.R.Darnall Army Medical Center Central Texas Veterans Health Care System VA Boston Healthcare System