Multicenter Clinical Trials for Efficacy and Safety of Mirtazapine in Moderate-to-Severe Major Depressive Patients / 대한정신약물학회지

ABSTRACT

OBJECTIVE: The purpose of this study is to evaluate the efficacy and safety of mirtazapine treatment in multicenter population consisting of Korean patients suffering from moderate-to-severe depression. METHODS: Total 163 of in and outpatients with a diagnosis of major depressive disorder (DSM-IV) and 18 or over scores of 17-items Hamilton Rating Scale for Depression (HAMD) received treatment with mirtazapine (15-45 mg/day) for 6 weeks. Efficacy was assessed by HAMD, Montgomery and Asberg Depression Rating Scale (MADRS), Beck's Depression Inventory (BDI), and Clinical Global Impression (CGI) scales and statistical analyses were performed on the intent-to-treat sample (143 patients) using the last-observation-carried-forward method. In addition, reported adverse events, routine laboratory parameters, and vital signs were investigated to evaluate the safety of mirtazapine. RESULTS: Mean daily dose of mirtazapine was 28.4 mg. At the end of the study, the response rate (50% or more reduction from baseline in HAMD scores) was 75.5% and the remission rate (7 or less in HAMD score) was 42.7%. Mirtazapine treatment induced significant reduction in depressive symptoms at the 4(th) day and substantial reduction along the treatment period, as assessed by changes in HAMD, MADRS, BDI, and CGI scales. At the 4(th) day and first week of mirtazapine treatment, the mean HAMD-17 total score was significantly reduced compared that of the baseline and the response rates were 11.9% and 28.7%, respectively. Mirtazapine was well tolerated in general, and somnolence and sedation were the most common adverse events reported. In addition, there were no clinically relevant changes in laboratory parameters and vital signs, although body weight was increased. CONCLUSION: Although this trial had many limitations of open non-comparative study, mirtazapine was demonstrated to an effective treatment for moderate to severe major depressive disorder and was well tolerated. A potentially rapid onset of overall therapeutic efficacy of mirtazapine was suggested by significant changes in all major variables of efficacy after 4(th) day of treatment.