PMID- 26504387 OWN - NLM STAT- PubMed-not-MEDLINE DCOM- 20151027 LR - 20201001 IS - 1176-6328 (Print) IS - 1178-2021 (Electronic) IS - 1176-6328 (Linking) VI - 11 DP - 2015 TI - Efficacy and safety of generic escitalopram (Lexacure((R))) in patients with major depressive disorder: a 6-week multicenter, randomized, rater-blinded, escitalopram-comparative, non-inferiority study. PG - 2557-64 LID - 10.2147/NDT.S90796 [doi] AB - OBJECTIVES: The primary aim of this non-inferiority study was to investigate the clinical effectiveness and safety of generic escitalopram (Lexacure((R))) versus branded escitalopram (Lexapro((R))) 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-Asberg 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: