ORG-3770 VERSUS AMITRIPTYLINE - A 6-WEEK RANDOMIZED DOUBLE-BLIND MULTICENTER TRIAL IN HOSPITALIZED DEPRESSED-PATIENTS

Following a placebo washout period of 3-7 days, 251 hospitalized patie nts with a major depressive episode (DSM III and RDC criteria) were tr eated with either Org 3770 (20-60 mg/day) or amitriptyline (75-225 mg/ day) for six consecutive weeks in this randomized, double-blind, multi centre study. Forty-one patients (19 Org 3770, 22 amitriptyline) withd rew before completion of the 6-week active treatment period. In both g roups, the main reason for withdrawal was lack of efficacy. However, f ewer patients in the Org 3770 group than in the amitriptyline group wi thdrew as a result of adverse events (one and three patients, respecti vely). The severity of depressive symptoms and general psychopathology , as assessed by HPRSD (total and factors) and BPRS scales, improved t o the same extent after 6 weeks' treatment with Org 3770 and amitripty line. Similar improvement in global functioning, as assessed by GAS sc ale, was observed in both treatment groups. There were no statisticall y significant differences between the two treatments on an scales used . Dry mouth and sweating were reported significantly more often in the amitriptyline group. Other adverse events, such as constipation, dizz iness, tremor and muscle weakness, occurred more frequently in the ami triptyline-treated patients as well. The results of this study indicat e that Org 3770 has similar antidepressant efficacy to amitriptyline a nd a more favourable tolerability profile in patients with major depre ssion.