MOCLOBEMIDE VERSUS FLUOXETINE IN THE TREATMENT OF MAJOR DEPRESSIVE DISORDER IN ADULTS

The objective of the present study was to compare the safety and effic acy of moclobemide versus fluoxetine in adult patients with major depr essive disorder. The design of the study was a multicenter, double-bli nd, comparative, and randomized trial. A 1- to 2-week single-blind pla cebo washout phase was followed by 6 weeks of double-blind treatment w ith moclobemide or fluoxetine. A total of 150 patients were enrolled i n the study. There were 128 patients eligible to be randomized, with 6 6 patients receiving moclobemide and 62 patients receiving fluoxetine. At the termination of the study, patients in the moclobemide group we re receiving a mean dose of 440 mg +/- 123 mg, while the mean dose in the fluoxetine group was 35 mg +/- 8 mg. No significant treatment diff erences were found for any of the efficacy parameters. Headache and na usea were the most frequently reported adverse events in both treatmen t groups. Headache and blurred vision were reported significantly more often (P < 0.05) in the fluoxetine group, whereas significantly more dry mouth was reported (P < 0.05) in the moclobemide group. These resu lts provide supporting evidence for the comparable efficacy of moclobe mide and fluoxetine and the better tolerability of moclobemide when us ed in the treatment of major depressive disorder.