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 oxida se inhibitor (MAOI) that also has serotonin reuptake inhibitory proper ties. Its dual pharmacologic effects offer promise in the treatment of a wide spectrum of depressed patients while producing less severe ant icholinergic side effects in comparison with standard drugs. A multice nter, double-blind, placebo-controlled study including 220 patients wa s undertaken to evaluate the efficacy and safety of brofaromine in maj or depression. This study of a fixed-dose design and 6 weeks' duration found that brofaromine was significantly better than placebo on the O verall Evaluation of Efficacy, Beck self-rating scale, HAM-D Bech subs cale, HAM-D total 14 items (minus the three sleep items), HAM-D depres sed mood item and retardation factor, and worse than placebo on the in somnia items of HAM-D. Significantly more patients on placebo than on brofaromine did not complete the trial due to lack of efficacy. In com parative controlled studies (n = 899), brofaromine was found to be at least as efficacious as tricyclic antidepressants (imipramine) and sta ndard MAOIs (tranylcypromine and phenelzine). Reductions of at least 5 0% in the HAM-D total score were seen in 58-66% of patients treated wi th either brofaromine or imipramine (n = 609). Brofaromine also was fo und to be of comparable efficacy to tranylcypromine in two clinical tr ials (n = 112), one of which included patients considered to have a tr eatment-resistant depression (n = 39). In another double-blind study t hat compared brofaromine (150 mg/day) to phenelzine (45 mg/day) (n = 1 5 8), there was no difference between brofaromine and phenelzine.