Efficacy and safety of moclobemide compared with maprotiline in treatment of major depressive disorder. A double-blind multicenter study with parallel groups.

This report describes the results obtained in a double-blind, six week, prospective, randomized multicenter study. The efficacy, tolerability, and safety of moclobemide (300-600 mg/d) were compared to those of maprotiline (75-150 mg/d) in parallel groups of patients with a Major Depressive Episode (DS-III). In addition, participants were required to have a minimum baseline total score of 17 on the 17-item Hamilton Depression Rating Scale (HAMD) (no run-in), 115 male or female outpatients (aged over 18 years) were randomly allocated to moclobemide t.i.d. (n = 58) or to maprotiline t.i.d. (n = 57). Demographic and illness characteristics were comparable in both treatment groups upon study entry. During the study the patients were not required to avoid tyramine-rich foods but they were advised to take trial medication after meals. Patients were assessed for efficacy and tolerability on days 4, 11, 18, 25, 32, 39, and 46. Efficacy was judged primarily on the HAMD, the investigator's final overall assessment, and on the number of premature terminations associated with insufficient efficacy. No significant difference was observed between both groups. The mean % reduction of the HAMD at the end of treatment was 62.2 in the moclobemide group and 61.2 in the maprotiline group. The percentage of patients in whom efficacy was globally judged as "good" or "very good" was 63.0% in the moclobemide group and 58.5% in the maprotiline group. Seventeen percent moclobemide patients and 21% of maprotiline patients did not complete because of insufficient efficacy.(ABSTRACT TRUNCATED AT 250 WORDS)