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, tolerabilit y, 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 t o have a minimum baseline total score of 17 on the 17-item Hamilton De pression Rating Scale (HAMD) (no run-in), 1 15 male or female outpatie nts (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 c haracteristics were comparable in both treatment groups upon study ent ry. 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, 1 8, 25, 32, 39, and 46. Efficacy was judged primarily on the HAMD, the investigator's final overall assessment, and on the number of prematur e terminations associated with insufficient efficacy. No significant d ifference was observed between both groups. The mean % reduction of th e HAMD at the end of treatment was 62.2 in the moclobemide group and 6 1.2 in the maprotiline group. The percentage of patients in whom effic acy was globally judged as ''good'' or ''very good'' was 63.0 % in the moclobemide group and 58.5 % in the maprotiline group. Seventeen perc ent moclobemide patients and 21 % of maprotiline patients did not comp lete because of insufficient efficacy. The final overall physician's j udgement of tolerability was ''good'' or ''very good'' in 82.8 % of mo clobemide patients and in 71.9 % of maprotiline patients. Adverse even ts were reported or observed in 45 % of moclobemide patients and in 66 % of maprotiline patients. The number of mild, moderate, and severe a dverse events was higher in the maprotiline group, with a total of 67 versus 44. This difference was mainly due to the higher incidence of a nticholinergic adverse events with maprotiline. Poor tolerability was given as the reason for premature termination for 10 % of patients on moclobemide and for 18 % of patients on maprotiline. Cardiovascular to lerability (blood pressure, heart rate, ECG, cardiovascular adverse ev ents) was satisfactory in both groups. Hematology, clinical chemistry, and urinalysis were not affected in a clinically significant fashion in either group. It is concluded that moclobemide is as effective as m aprotiline for the treatment of a Major Depressive Episode, but may be better tolerated.