Korean J Psychopharmacol.  2007 Jan;18(1):36-49.

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

Affiliations
  • 1Department of Psychiatry and Institute of Human Behavioral Medicine, Seoul National University College of Medicine, Seoul, Korea. kys@snu.ac.kr
  • 2Department of Psychiatry, Seoul National University Hospital, Seoul, Korea.
  • 3Department of Psychiatry, School of Medicine, Inha University, Incheon, Korea.
  • 4Department of Psychiatry, College of Medicine, Chungang University, Seoul, Korea.
  • 5Department of Psychiatry, College of Medicine, Wonkwang University, Iksan, Korea.
  • 6Department of Psychiatry, College of Medicine, Gyeongsang National University, Jinju, Korea.
  • 7Department of Psychiatry, Hallym University College of Medicine, Hangang Sacred Heart Hospital, Seoul, Korea.
  • 8Department of Psychiatry, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
  • 9Department of Psychiatry, College of Medicine, Dankook University, Cheonan, Korea.
  • 10Department of Psychiatry, College of Medicine, Dongguk University, Gyeongju, Korea.
  • 11Department of Psychiatry, College of Medicine, Inje University, Sanggye Paik Hospital, Seoul, Korea.
  • 12Department of Neuropsychiatry, School of Medicine, and Institute of Neuroscience, Inje University, Pusan Paik Hospital, Busan, Korea.
  • 13Department of Psychiatry, School of Medicine, Catholic University of Daegu, Daegu, Korea.
  • 14Department of Psychiatry, Kangnam St. Mary's Hospital, The Catholic University of Korea, College of Medicine, Seoul, Korea.
  • 15Department of Psychiatry, St. Mary's Hospital, The Catholic University of Korea, College of Medicine, Seoul, Korea.
  • 16Department of Psychiatry, Chonbuk National University Medical School, Jeonju, Korea.
  • 17Department of Psychiatry, College of Medicine, Chungnam National University, Daejeon, Korea.

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.

Keyword

Mirtazapine; Depression; Efficacy; Safety
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