Moclobemide twice daily in the treatment of major depressive episode: a double-blind, multicenter comparison with different three times daily dosage schedules.
The data on a twice-daily dosage schedule with moclobemide in the treatment of a major depressive episode (MDE) is limited. In this randomized, double-blind, multicenter study, moclobemide, 150 mg twice daily, was compared with two different three times daily regimens with total daily dosages of 300 and 450 mg, respectively, over a 6-week period. Two hundred seventy patients were included, of whom 237 completed the study. The treatment groups were comparable with respect to demographic parameters and severity of depression at baseline. No clear differences between the treatment groups could be shown with respect to response on the Hamilton Rating Scale for Depression (HAM-D), the Zung Self Rating Scale, or the Clinical Global Impression of efficacy and severity. There was, however, a slightly higher response rate with respect to the anxiety/agitation subscale of the HAM-D in the 150-mg twice-daily group. In all groups, there was a marked and comparable response with respect to suicide ideation. There were no marked differences between the groups with respect to the type and frequency of adverse events. Tolerability was rated "good" or "excellent" in 93% of patients, and there was no appreciable change in blood pressure, pulse rate, or body weight in any of the treatment groups over the study period. The three dosage schedules of moclobemide studied are effective and well tolerated in the treatment of patients with MDE. Moclobemide, 150 mg twice daily, is the optimal initial daily dosage schedule.