Five multicentre randomised, double-blind, placebo-controlled studies (total number of patients not stated).
Studies in civilian patients (n=3): Sertraline significantly reduced symptoms of PTSD compared with placebo in 2 of the 3 studies. The response rates were 53% and 60% for sertraline compared with 32 and 39% for placebo for the two studies that reported this information.
Combat induced PTSD (n=2):
Sertraline improved symptoms compared to placebo in one study but no significant improvement was observed in a second study.
Tolerability (n=2)
Sertraline was generally well tolerated with the most common (incidence >=10%) adverse events reported being headache, diarrhoea, insomnia, nausea, somnolence, malaise and dry mouth. Only insomnia, diarrhoea and nausea occurred significantly more frequently amongst patients treated with sertraline as compared with placebo. There was no difference in the number of sertraline and placebo treated patients who discontinued treatment because of adverse effects.