A CANADIAN MULTICENTER PLACEBO-CONTROLLED STUDY OF A FIXED-DOSE OF BROFAROMINE, A REVERSIBLE SELECTIVE MAO-A INHIBITOR, IN THE TREATMENT OFMAJOR DEPRESSION

In a 6-week double-blind study, 220 patients with major depression (mo stly outpatients) were randomly assigned to receive a fixed dose of br ofaromine 150 mg daily (n = 111) or placebo (n = 109) after a 1-week s ingle-blind placebo washout. Except for the HAM-D sleep items, brofaro mine was superior to placebo on measures of depression as determined b y the four methods of assessing drug efficacy: (1) psychiatric symptom rating (HAM-D 17-item less the three sleep items); (2) self-rating sc ale (Beck Depression Inventory); (3) Clinical Global Assessment of Eff icacy; and (4) drop-out rate due to lack of efficacy. Most commonly-re ported adverse events with brofaromine were: headache, nausea, dizzine ss and sleep disturbance. Brofaromine was found to be an effective ant idepressant, superior to placebo with a good tolerability profile.