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      PS85. 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

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          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 MADRS), the 17-item HDRS, the CGI-S, and the 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: 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. 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.

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          Author and article information

          Journal
          Int J Neuropsychopharmacol
          Int. J. Neuropsychopharmacol
          ijnp
          International Journal of Neuropsychopharmacology
          Oxford University Press (US )
          1461-1457
          1469-5111
          June 2016
          27 May 2016
          : 19
          : Suppl 1
          : 29
          Affiliations
          [1 ]The Catholic University of Korea, Republic of Korea
          [2 ]Hallym University, Republic of Korea
          [3 ]Jeju National University, Republic of Korea
          [4 ]Inje University, Republic of Korea
          [5 ]Dongguk University, Republic of Korea
          [6 ]Uijeongbu St. Mary's Hospital, Republic of Korea
          [7 ]Chonbuk National University Hospital, Republic of Korea
          Article
          pyw043.085
          10.1093/ijnp/pyw043.085
          5616682
          d0f65baa-19f8-431e-a644-789fe72b8d47
          © The Author 2016. Published by Oxford University Press. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.
          History
          Page count
          Pages: 1
          Categories
          Abstracts
          Sunday Abstracts

          Pharmacology & Pharmaceutical medicine
          Pharmacology & Pharmaceutical medicine

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