SERTRALINE IN THE TREATMENT OF PANIC DISORDER - A MULTISITE, DOUBLE-BLIND, PLACEBO-CONTROLLED, FIXED-DOSE INVESTIGATION

Background This study compared the efficacy and safety of sertraline t o placebo in treating panic disorder. Method 178 out-patients with pan ic disorder who exhibited at least four panic attacks during the four weeks prior to screening and three during the two weeks of lead-in wer e randomly assigned to 12 weeks of double-blind treatment with sertral ine (50, 100 or 200 mg) or placebo. Results Sertraline was superior to placebo in reducing tbe number of panic attacks, situational attacks, unexpected attacks, limited symptom attacks, and time spent worrying (all P <0.0 I) and the Hamilton Anxiety scale (P < 0.05), although Cli nical Global Impression (Improvement) did not significantly differenti ate ro ups at 12 weeks and at end-point. No serious adverse event were associated with sertraline, No dose relationship was found for advers e events; overall drop-out rates were not different for sertraline or placebo, although more sertraline-treated subjects discontinued for ad verse events, typically early in the study Only dry mouth and ejaculat ion failure (primarily ejaculation delay) were associated significantl y with sertraline. Conclusions Sertraline was effective and safe in re ducing panic attacks. Higher doses were no more effective than the 50 mg dose.