Double-blind, Multicenter Comparative Study of Sertraline versus Amitriptyline in Outpatients with Major Depression

Objective: To compare the efficacy and safety of sertraline and amitriptyline in a German outpatient population. Methods: Patients with Major Depression (DSM-III-R) and HAM-D (21 items) ≥ 21 in 19 German centers received double-blind treatment with sertraline (initial dose 50 mg, titration up to 100 mg) or amitriptyline (75 mg, up to 150 mg) over 6 weeks. HAM-D (21 items), HAM-D Bech, CGI, DSI and SDS were evaluated for the efficacy analysis. FSUCL (Fischer Somatic and Undesired Effects Check List) and spontaneously reported adverse events were used for safety analysis. Results: Of the 240 patients enrolled in the study, 205 (100 sertraline; 105 amitriptyline) were evaluable for efficacy. No statistically significant differences were detected between the two groups in the ITT and ATP efficacy analyses. Response, defined as score 1 (very much improved) or 2 (much improved) of the CGI improvement score, was 76 % in the sertraline and 81 % in the amitriptyline group (efficacy evaluable patients = ATP population). In the structured FSUCL, the side-effect burden (FSUCL score > 2 for drug related symptoms) was significantly higher in the amitriptyline group at all follow up visits (p < 0.05). Conclusion: Both sertraline and amitriptyline are suitable for the treatment of Major Depression; sertraline is comparable to amitriptyline with regard to efficacy, and offers the additional benefit of a more favorable safety profile.

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