Fluoxetine in the acute treatment and relapse prevention of combat-related post-traumatic stress disorder: Analysis of the veteran group of a placebo-controlled, randomized clinical trial.

Author(s): Martenyi F, Soldatenkova V

Affiliation(s): Eli Lilly Area Medical Center, Kolblgasse 8-10, Vienna A-1031, Austria.

Publication date & source: 2005-12-12, Eur Neuropsychopharmacol., [Epub ahead of print]

Publication type:

The efficacy and safety of fluoxetine (20-80 mg) was compared with placebo in 144 veterans [36.2 years], diagnosed with combat-related post-traumatic stress disorder (PTSD) selected from a 12-week acute and 24-week relapse prevention PTSD trial. In the acute phase, improvements were greater with fluoxetine than placebo in the disease-specific outcome measures: Treatment Outcome PTSD (TOP-8) total scores (SE):-9.05 (0.90) and -5.20 (1.23), p=0.001; Clinician Administered PTSD Scale (CAPS) total scores:-31.12 (2.72) and -16.07 (4.24), p<0.001; all CAPS subscores; Davidson Trauma Scale (DTS) total scores; and other general outcome measures. In the maintenance phase, fluoxetine was superior to placebo in sustaining improvement in TOP-8 [-1.01 (0.91) and 1.56 (0.95)] and CAPS [-4.93 (3.54) and 5.48 (3.66)]. The risk of relapse in the placebo arm was significantly greater than in the fluoxetine arm (log-rank test chi(2)=4.090, df=1, p=0.048). Fluoxetine was well tolerated at a mean daily dose of 65 mg.