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

Jong-Hyun Jeong; Won-Myong Bahk; Young Sup Woo; Kyung-Uk Lee; Do Hoon Kim; Moon-Doo Kim; Won Kim; Jong-Chul Yang; Kwang Heun Lee

doi:10.2147/NDT.S90796

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

Neuropsychiatr Dis Treat. 2015 Oct 9:11:2557-64. doi: 10.2147/NDT.S90796. eCollection 2015.

Authors

Jong-Hyun Jeong¹, Won-Myong Bahk¹, Young Sup Woo¹, Kyung-Uk Lee¹, Do Hoon Kim², Moon-Doo Kim³, Won Kim⁴, Jong-Chul Yang⁵, Kwang Heun Lee⁶

Affiliations

¹ Department of Psychiatry, College of Medicine, The Catholic University of Korea, Seoul, South Korea.
² Department of Psychiatry, Chuncheon Sacred Heart Hospital, Hallym University, Chuncheon, South Korea.
³ Department of Psychiatry, Jeju National University Hospital, Jeju, South Korea.
⁴ Department of Psychiatry, Stress Research Institute, Seoul Paik Hospital, College of Medicine, Inje University, Seoul, South Korea.
⁵ Department of Psychiatry, Chonbuk National University Medical School, Jeonju, South Korea.
⁶ Department of Psychiatry, College of Medicine, Dongguk University, Gyeongju, South Korea.

Abstract

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: Lexacure®; Lexapro®; branded escitalopram; depression; generic escitalopram.