Efficacy and safety of generic escitalopram (Lexacure®) in patients with major depressive disorder: a 6-week multicenter, randomized, rater-blinded, escitalopram-comparative, non-inferiority study

Abstract

Jong-Hyun Jeong,1 Won-Myong Bahk,1 Young Sup Woo,1 Kyung-Uk Lee,1 Do Hoon Kim,2 Moon-Doo Kim,3 Won Kim,4 Jong-Chul Yang,5 Kwang Heun Lee6 1Department of Psychiatry, Yeouido St Mary’s Hospital, College of Medicine, The Catholic University of Korea, Seoul, 2Department of Psychiatry, Chuncheon Sacred Heart Hospital, Hallym University, Chuncheon, 3Department of Psychiatry, Jeju National University Hospital, Jeju, 4Department of Psychiatry, Stress Research Institute, Seoul Paik Hospital, College of Medicine, Inje University, Seoul, 5Department of Psychiatry, Chonbuk National University Medical School, Jeonju, 6Department of Psychiatry, College of Medicine, Dongguk University, Gyeongju, South Korea Objectives: The primary aim of this non-inferiority study was to investigate the clinical effectiveness and safety of generic escitalopram (Lexacure®) versus branded escitalopram (Lexapro®) for patients with major depressive disorder (MDD).Methods: The present study included 158 patients, who were randomized (1:1) to receive a flexible dose of generic escitalopram (n=78) or branded escitalopram (n=80) over a 6-week single-blind treatment period. The clinical benefits in the two groups were evaluated using the Montgomery–Åsberg Depression Rating Scale (MADRS), the 17-item Hamilton Depression Rating Scale (HDRS), the Clinical Global Impressions-Severity scale (CGI-S), and the Clinical Global Impressions-Improvement scale (CGI-I) at baseline, week 1, week 2, week 4, and week 6. The frequency of adverse events (AEs) was also assessed to determine safety at each follow-up visit.Results: During the 6-week study period, 30 patients (38.5%) from the generic escitalopram group and 28 patients (30.0%) from the branded escitalopram group dropped out of the study (P=0.727). The MADRS, HDRS, CGI-S, and CGI-I scores significantly decreased in both groups, and there were no significant differences between the groups. At week 6, 28 patients (57.1%) in the generic escitalopram group and 35 patients (67.3%) in the branded escitalopram group had responded to treatment (as indicated by a ≥50% decrease from the baseline MADRS score; P=0.126), and the remission rates (MADRS score: ≤10) were 42.9% (n=21) in generic escitalopram group and 53.8% (n=28) in the branded escitalopram group (P=0.135). The most frequently reported AEs were nausea (17.9%), sleepiness/somnolence (7.7%), weight gain (3.8%), and dry mouth (2.6%) in the generic escitalopram group and nausea (20.0%), sleepiness/somnolence (3.8%), weight gain (2.5%), and dry mouth (2.5%) in the branded escitalopram group.Conclusion: The present non-inferiority study demonstrated that generic escitalopram is a safe and an effective initial treatment for patients with MDD and may also be considered as an additional therapeutic option for this population. Keywords: depression, branded escitalopram, Lexapro®, generic escitalopram, Lexacure®