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 amitriptyline and placebo, in outpatients with major depression (DSM-III 296.2 or 296.3). One hundred and forty-nine patients were randomized to mianserin (n = 50), amitriptyline (n = 50) or placebo (n = 49). Medication was taken in a nightly (qhs) dose. During Week 1, the maximum dose was 60 mg mianserin, 120 mg amitriptyline or two placebo capsules. Beginning at Day 7 (through Day 42) maximum dosages were 150 mg mianserin, 300 mg amitriptyline or five placebo capsules. At multiple weeks and endpoint, statistically significant reductions in the Hamilton Depression Scale (HAM-D) 17- and 21-item scores were recorded for both active drugs compared with placebo. Positive results with the HAM-D were corroborated by other measures of efficacy. There were no statistically significant differences between mianserin and amitriptyline in terms of efficacy; however, the results do suggest a more rapid therapeutic response for mianserin compared with amitriptyline, in terms of percentage of patients showing > or = 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 dry mouth (amitriptyline 76%, mianserin 30% and placebo 20%). Our results indicate that mianserin is clearly superior to placebo, compares favorably with amitriptyline, and is a safe, well-tolerated, effective medication in the treatment of depressed outpatients.
Wilcox
C S
CS
Pharmacology Research Institute, Irvine, CA.
Cohn
J B
JB
Katz
B B
BB
Mijares
C P
CP
Guarino
J J
JJ
Panagides
J
J
DeFrancisco
D F
DF
D000328:Adult; D000553:Ambulatory Care; D000639:Amitriptyline / Q000627:therapeutic use*; D000928:Antidepressive Agents / Q000627:therapeutic use; D003866:Depressive Disorder / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008803:Mianserin / Q000627:therapeutic use*; D010919:Placebos
D000928:Antidepressive Agents; D010919:Placebos; D000639:Amitriptyline; D008803:Mianserin