A double-blind study of the efficacy and safety of sertraline and clomipramine in outpatients with severe major depression

This study compared the efficacy and safety of the selective serotonin reup take inhibitor sertraline with that of the tricyclic antidepressant clomipr amine in patients with severe depression, as defined by a baseline 17-item Hamilton Depression Rating Scale (HAM-D) of at least 25. The study included 166 outpatients, randomized to double-blind treatment with sertraline (50- 200 mg) or clomipramine (50-150 mg) for 8 weeks. The efficacy of both treat ments was similar, 74% of patients in the sertraline group and 71% of clomi pramine patients being classified as responders at the end-point, as define d by a Clinical Global Impression Improvement (CGI-I) score of 1 or 2. Mean HAM-D scores fell from 29.8 at baseline to 12.3 at endpoint in the sertral ine group, and from 29.6-12.7 in the clomipramine group. There were more wi thdrawals due to adverse events in the clomipramine group than in the sertr aline group (17% versus 12%). Dry mouth, tremor, dizziness and constipation were all substantially more common in the clomipramine group, whereas diar rhoea/loose stools was more common in the sertraline group. Overall, sertra line was as effective as clomipramine in this group of severely depressed o utpatients, and showed better tolerability. (C) 2000 Lippincott Williams & Wilkins.