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

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

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 (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%) in the generic escitalopram group and nausea (20.0%) in the branded escitalopram group.

Conclusions

The present non-inferiority study demonstrated that generic escitalopram is a safe and effective initial treatment for patients with MDD and may also be considered as an additional therapeutic option for this population.

Disclosure of interest

The authors have not supplied their declaration of competing interest.