Korean Journal of Biological Psychiatry

This was an open trial to evaluate the efficacy and safety of moclobemide twice daily for treatment of Korean patients with major depressive disorder(DSM-III-R). The duration of the trial was 6 weeks with initial dose of moclobemide being fixed for the first two weeks at 300mg/ day(150mg twice daily, each taken after morning and evening meals). Thereafter, when necessary, the dose was allowed to increase to 600mg/day or decrease to 150mg/day according to the severity of the depression and/or the tolerability of the drug. Hypnotics and/or sedatives from a benzodiazepine group could be concomitantly administered at usual dosage. Patients were assessed at baseline and at days 14, 28 and 42. Efficacy was primarily judged on the Hamilton Rating Scale for Depression(HAM-D) and Beck Depression Inventory(BDI). Patients had to score at least 17 respectively on both scales to enter the trial. Secondary efficacy parameters included Clinical Global Impression(CGI) for severity of illness and improvement. Safety and tolerability were judged on reported adverse events, vital signs and laboratory parameters. In addition, there was a series of questions and assessments for the psychiatrists and patients to complete at the end of the trial. Twenty nine patients completing trial were included in the analysis of efficacy ; of thirty one patients participating in the safety and tolerability analysis, those who withdraw voluntarily without particular reasons or violated the treatment schedule were not included. The efficacies as determined by HAM-D, BDI or CGI were found to be significant compared to vaseline. The number of responders defined as patients with a total score of 10 or less or with a total score of 50% or less of the baseline score on HAM-D and BDI were 17(59%) and 18(62%) respectively. Regarding safety and tolerability, nine patients(29%) reported mild adverse events probably related to moclobemide ; of these one patient dropped out because of poor tolerability ; however, there were no appreciable changes in blood pressure, pulse rate, body weight or laboratory parameters for all patients over the trial period. Furthermore, the physicians' and patients' opinions at final evaluation showed that moclobemide has a good antidepressant effect as well as a favorable tolerability. In conclusion, a twice-daily dosage schedule with moclobemide is recommendable for the treatment of Korean patients with major depressive disorder since its efficacy and safety were demonstrated in this study.

Keywords Moclobemide;Efficacy;Safety;Major depressive disorder.