SERTRALINE SAFETY AND EFFICACY IN MAJOR DEPRESSION - A DOUBLE-BLIND FIXED-DOSE COMPARISON WITH PLACEBO

In a 6-week, randomized, double-blind, multicenter trial, sertraline 5 0 mg, 100 mg, or 200 mg, or placebo, was administered once daily to 36 9 patients with DSM-III-defined major depression. Efficacy variables i ncluded changes from baseline scores for total Hamilton Rating Scale f or Depression (HAMD), HAMD Bech Depression Cluster, Clinical Global Im pressions (CGI) Severity, CGI improvement, and Profile of Mood States Depression/Dejection Factor. For the evaluable-patients analysis, all sertraline groups showed significantly (p < 0.05 or better) greater im provements in all efficacy variables except one when compared with the placebo group. For the all-patients analysis, all efficacy variables in the 50 mg group were statistically significantly (p < 0.05) better than placebo. Side effects increased with increasing dosage but were u sually mild and well tolerated The results of this study show that ser traline 50 mg once daily is as effective as higher dosages for the tre atment of major depression with fewer side effects and therapy discont inuations.