DOUBLE-BLIND, MULTICENTER COMPARATIVE-STUDY OF SERTRALINE AND AMITRIPTYLINE IN HOSPITALIZED-PATIENTS WITH MAJOR DEPRESSION

Sertraline is a selective serotonin reuptake inhibitor (SSRI) for whic h marketing approval has been obtained recently in Germany, The result s of several double-blind, placebo-controlled studies have demonstrate d that sertraline has a clear antidepressive effect. However these stu dies have been conducted in outpatient populations, In the context of this multicenter study, a total of 160 inpatients were treated with se rtraline 50-150 mg or amitriptyline 75-225 mg over a period of 6 weeks in a double-blind fashion, Sixty-two patients in the sertraline and 5 9 patients in the amitriptyline group were evaluated for efficacy in t he according-to-protocol (ATP) population; 80 sertraline and 75 amitri ptyline patients were evaluated for safety in the Intention-to-treat p opulation (ITT). No statistically significant differences were detecte d between the two groups in the efficacy analysis performed on the bas is of the Hamilton Depression Scale (HAM-D) total score and Clinical G lobal Impression (CGI). Due to its sedating properties, amitriptyline was found to be significantly more effective with regard to the HAM-D factor ''sleep disturbance''. The safety analysis, which was based on the CGI, the global assessment at the end of study and a score for som atic adverse events (FSUCL) revealed statistically significant advanta ges of sertraline over amitriptyline. Amitriptyline was associated wit h more autonomic and circulatory side effects, while epigastric compla ints occurred more often with sertraline. The incidence of nausea - a typical SSRI side effect - was the same in both groups.