Methodologies and outcomes from the sertraline multicenter flexible-dose trials

This article summarizes the results of a combined analysis from two identic al multicenter clinical trials that investigated the efficacy and safety of sertraline versus placebo for treating panic disorder. Patients with panic disorder who were treated with sertraline had a statistically significant reduction in the mean number of panic attacks per week (the primary efficac y measure) as compared with placebo (4.8 vs. 2.5, p<.001). Sertraline-treat ed patients also showed greater improvement that was statistically signific ant on several ratings of panic disorder symptomatology and functioning. Th e design characteristics, clinical rating measures, and outcome measures in these trials included most of the features deemed essential by Shear and M aser (1994) in their summary of the NIMH Consensus Conference for the devel opment of standardized assessments for panic disorder. This suggests that t he NIMH Consensus Conference played a key role in developing successful mul ticenter pharmacological treatment studies, such as this one that ultimatel y demonstrated that sertraline was an effective treatment for panic disorde r.