A DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY COMPARING MIANSERIN AND AMITRIPTYLINE IN MODERATELY DEPRESSED OUTPATIENTS

We report on the results of a study comparing mianserin with amitripty line and placebo, in outpatients with major depression (DSM-III296.2 o r 296.3). One hundred and forty-nine patients were randomized to mians erin (n = 50), amitriptyline(n = 50) or placebo (n = 49). Medication w as taken in a nightly (qhs) dose. During Week 1, the maximum dose was 60 mg mianserin, 120 mg amitriptyline or two placebo capsules. Beginni ng at Day 7 (through Day 42) maximum dosages were 150 mg mianserin, 30 0 mg amitriptyline or five placebo capsules. At multiple weeks and end point, statistically significant reductions in the Hamilton Depression Scale (HAM-D) 17- and 21-item scores were recorded for both active dr ugs compared with placebo. Positive results with the HAM-D were corrob orated by other measures of efficacy. There were no statistically sign ificant differences between mianserin and amitriptyline in terms of ef ficacy; however, the results do suggest a more rapid therapeutic respo nse for mianserin compared with amitriptyline, in terms of percentage of patients showing greater than or equal to 50% improvement at Weeks 2 (30% vs 23%) and 4 (61% vs 44%). The most common adverse experiences were somnolence (amitriptyline and mianserin 60%, placebo 31%) and dr y mouth (amitriptyline 76%, mianserin 30% and placebo 20%). Our result s indicate that mianserin is clearly superior to placebo, compares fav orably with amitriptyline, and is a safe, well-tolerated, effective me dication in the treatment of depressed outpatients.