Brofaromine in depression: a Canadian multicenter placebo trial and a review of standard drug comparative studies.
Brofaromine is a new, reversible, and selective type-A monoamine oxidase inhibitor (MAOI) that also has serotonin reuptake inhibitory properties. Its dual pharmacologic effects offer promise in the treatment of a wide spectrum of depressed patients while producing less severe anticholinergic side effects in comparison with standard drugs. A multicenter, double-blind, placebo-controlled study including 220 patients was undertaken to evaluate the efficacy and safety of brofaromine in major depression. This study of a fixed-dose design and 6 weeks' duration found that brofaromine was significantly better than placebo on the Overall Evaluation of Efficacy, Beck self-rating scale, HAM-D Bech subscale, HAM-D total 14 items (minus the three sleep items), HAM-D depressed mood item and retardation factor, and worse than placebo on the insomnia items of HAM-D. Significantly more patients on placebo than on brofaromine did not complete the trial due to lack of efficacy. In comparative controlled studies (n = 899), brofaromine was found to be at least as efficacious as tricyclic antidepressants (imipramine) and standard MAOIs (tranylcypromine and phenelzine). Reductions of at least 50% in the HAM-D total score were seen in 58-66% of patients treated with either brofaromine or imipramine (n = 609). Brofaromine also was found to be of comparable efficacy to tranylcypromine in two clinical trials (n = 132), one of which included patients considered to have a treatment-resistant depression (n = 39). In another double-blind study that compared brofaromine (150 mg/day) to phenelzine (45 mg/day) (n = 158), there was no difference between brofaromine and phenelzine.
Chouinard
G
G
Hôpital Louis-H. Lafontaine, Montreal, Quebec, 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; D000368:Aged; D000928:Antidepressive Agents / Q000627:therapeutic use*; D002170:Canada; D003866:Depressive Disorder / Q000188:drug therapy* / Q000523:psychology; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007099:Imipramine / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D008996:Monoamine Oxidase Inhibitors / Q000627:therapeutic use*; D010624:Phenelzine / Q000627:therapeutic use; D010880:Piperidines / Q000627:therapeutic use*; D011569:Psychiatric Status Rating Scales; D014191:Tranylcypromine / Q000627:therapeutic use
D000928:Antidepressive Agents; D008996:Monoamine Oxidase Inhibitors; D010880:Piperidines; D014191:Tranylcypromine; C038213:brofaromine; D010624:Phenelzine; D007099:Imipramine