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.


OBJECTIVE
To demonstrate that fluoxetine is more effective than placebo in treating PTSD.


METHODS
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% CI 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 traditional global rating criterion.
Connor
K M
KM
Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, North Carolina 27710, USA.
Sutherland
S M
SM
Tupler
L A
LA
Malik
M L
ML
Davidson
J R
JR
D000293:Adolescent; D000328:Adult; D018687:Antidepressive Agents, Second-Generation / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D005473:Fluoxetine / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D013313:Stress Disorders, Post-Traumatic / Q000188:drug therapy*; D016896:Treatment Outcome
D018687:Antidepressive Agents, Second-Generation; D005473:Fluoxetine