Effect and safety of sertraline for treat posttraumatic stress disorder: a multicenter randomised controlled study

OBJECTIVE: Although several previous studies have examined the efficacy of sertraline in the treatment of posttraumatic stress disorder (PTSD), none involved Chinese PTSD patients. This study aimed to evaluate sertraline efficacy and adverse events in Chinese patients with PTSD over 12 weeks. METHODS: In total, 72 PTSD patients were randomly assigned to receive sertraline (135 mg daily) or a placebo for 12 weeks. Impact of Event Scale-Revised subscores constituted the primary outcome, with Clinical Global Impression Scale-Severity scores and adverse events as secondary outcomes. RESULTS: Sixty-five subjects completed the study, and their data were included in the final analysis. Sertraline showed greater efficacy in enhancing Impact of Event Scale-Revised and Clinical Global Impression Scale-Severity scores at 6 and 12 weeks relative to that of the placebo. The most common adverse event was nausea, which occurred in 12 (33.3%) and 8 (22.2%) patients in the sertraline and placebo groups, respectively. No sertraline-related deaths were recorded. CONCLUSIONS: In summary, we demonstrated that 12 weeks of sertraline was efficacious and well-tolerated in Chinese patients with PTSD.