Fluoxetine in post-traumatic stress disorder - Randomised, double-blind study

Background Most pharmacotherapy trials in post-traumatic stress disorder (PTSD) have been conducted upon male combat veterans. Outcome studies relating to civilians are therefore needed. Aims To demonstrate that fluoxetine is more effective than placebo in treating PTSD. Method Civilians with PTSD (n=53) were treated for 12 weeks with fluoxetine(up to 60 mg/day) or placebo. Assessments of PTSD severity, disability, stress vulnerability, and high end-state function were obtained. Results Fluoxetine was more effective than placebo on most measures at week 12, including global improvement (much or very much improved: fluoxetine 85%, placebo 62%, difference 0.24, 95% Cf 0.01-0.47; very much improved: fluoxetine 59%, placebo 19%, difference 0.40, 95% CI 0.16-0.64), and high end-state function (fluoxetine 41%, placebo 4%, difference 0.37, 95% CI 0.17-0.57). Conclusions Fluoxetine was superior for measures of PTSD severity, disability, stress vulnerability, and high end-state function. The placebo-group response was low when viewed as a broad outcome based on a portfolio of ratings, but was higher with a tradition al global rating criterion. Declaration of interest This study was supported by a grant from the National Institute of Mental Health.