A Canadian multicentre placebo-controlled study of a fixed dose of brofaromine, a reversible selective MAO-A inhibitor, in the treatment of major depression.
In a 6-week double-blind study, 220 patients with major depression (mostly outpatients) were randomly assigned to receive a fixed dose of brofaromine 150 mg daily (n = 111) or placebo (n = 109) after a 1-week single-blind placebo washout. Except for the HAM-D sleep items, brofaromine was superior to placebo on measures of depression as determined by the four methods of assessing drug efficacy: (1) psychiatric symptom rating (HAM-D 17-item less the three sleep items); (2) self-rating scale (Beck Depression Inventory); (3) Clinical Global Assessment of Efficacy; and (4) drop-out rate due to lack of efficacy. Most commonly reported adverse events with brofaromine were: headache, nausea, dizziness and sleep disturbance. Brofaromine was found to be an effective antidepressant, superior to placebo with a good tolerability profile.
Chouinard
G
G
Hôpital Louis-H. Lafontaine, Montréal, Québec, Canada.
Saxena
B M
BM
Nair
N P
NP
Kutcher
S P
SP
Bakish
D
D
Bradwejn
J
J
Kennedy
S H
SH
Sharma
V
V
Remick
R A
RA
Kukha-Mohamad
S A
SA
D000293:Adolescent; D000328:Adult; D003866:Depressive Disorder / Q000188:drug therapy* / Q000523:psychology; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D008996:Monoamine Oxidase Inhibitors / Q000008:administration & dosage* / Q000009:adverse effects; D010555:Personality Inventory; D010880:Piperidines / Q000008:administration & dosage* / Q000009:adverse effects
D008996:Monoamine Oxidase Inhibitors; D010880:Piperidines; C038213:brofaromine