title: Efficacy and Tolerability of Generic Mirtazapine (Mirtax) for Major Depressive Disorder: Multicenter, Open-label, Uncontrolled, Prospective Study.
abstract: OBJECTIVE
  Mirtax is a generic mirtazapine widely used since 2003. We conducted an open-label, uncontrolled 6-week study to evaluate the efficacy and safety of Mirtax for major depressive disorder (MDD).
  
  
  METHODS
  Ninety three MDD patients with the diagnosis of MDD and 17-item Hamilton Depression Rating Scale (HDRS) score ≥14 were recruited. The HDRS, Montgomery-Åsberg Depression Rating Scale (MADRS), and the Clinical Global Impressions-Severity Scale (CGI-S) were administered at baseline, 1, 2, 4 and 6 weeks. Response (≥50% decrease in the HDRS or MADRS score), remission (absolute HDRS score ≤7 or MADRS score ≤10) and CGI-I score ≤2 were also calculated. Adverse event (AE) frequency and severity, weight, blood pressure, and pulse rate were checked to assess safety.
  
  
  RESULTS
  The starting dosage was 11.5±6.4 mg/day, and the maintenance dosage was 23.1±9.4 mg/day. During 6 weeks, HDRS, MADRS and CGI-S scores decreased from 25.1±5.6 to 11.9±8.6 (mean change -13.1±8.3, p<0.001), from 30.2±6.3 to 13.73±10.40 (mean change -16.5±9.8, p<0.001), and from 5.0±0.8 to 2.5±1.3 (mean change -2.5±1.3, p<0.001), respectively. The percentages of responders, remitters by HDRS and patients with a CGI-I score ≤2 were 64.6%, 35.4% and 52.7%, respectively. Significant decreases in HDRS, MADRS and CGI-S scores were confirmed at week 1. The total rate of AEs was 32.3%; the most frequently reported AEs were sedation (4.3%) and constipation (4.3%). Weight was increased from 58.8±10.6 to 60.3±9.3 kg (mean change 0.7±1.7 kg, p=0.004).
  
  
  CONCLUSIONS
  This study, as the first clinical trial of generic mirtazapine, demonstrated the efficacy and tolerability of Mirtax for MDD using a single treatment design.
authors.affiliation: Department of Psychiatry, Soonchunhyang University Cheonan Hospital, Cheonan, Korea.|College of Medicine, The Catholic University of Korea, Seoul, Korea.
authors.forename: Hoo Rim
authors.initials: HR
authors.lastname: Song
authors.affiliation: College of Medicine, The Catholic University of Korea, Seoul, Korea.
authors.forename: Won-Myong
authors.initials: WM
authors.lastname: Bahk
authors.affiliation: College of Medicine, The Catholic University of Korea, Seoul, Korea.
authors.forename: Young Sup
authors.initials: YS
authors.lastname: Woo
authors.affiliation: College of Medicine, The Catholic University of Korea, Seoul, Korea.
authors.forename: Jong-Hyun
authors.initials: JH
authors.lastname: Jeong
authors.affiliation: Department of Psychiatry, Soonchunhyang University Cheonan Hospital, Cheonan, Korea.
authors.forename: Young-Joon
authors.initials: YJ
authors.lastname: Kwon
authors.affiliation: Konkuk University Chungju Hospital, Chungju, Korea.
authors.forename: Jeong Seok
authors.initials: JS
authors.lastname: Seo
authors.affiliation: Inje University Seoul Paik Hospital, Seoul, Korea.
authors.forename: Won
authors.initials: W
authors.lastname: Kim
authors.affiliation: Jeju National University Hospital, Jeju, Korea.
authors.forename: Moon-Doo
authors.initials: MD
authors.lastname: Kim
authors.affiliation: Kangbuk Samsung Hospital, Seoul, Korea.
authors.forename: Young-Chul
authors.initials: YC
authors.lastname: Shin
authors.affiliation: Wonkwang University Hospital, Iksan, Korea.
authors.forename: Sang-Yeol
authors.initials: SY
authors.lastname: Lee
authors.affiliation: Chung-Ang University Hospital, Seoul, Korea.
authors.forename: Kyung Joon
authors.initials: KJ
authors.lastname: Min
keywords: Efficacy; Generic drugs; Mirtazapine; Tolerability