• Fernanda S Correia-Melo, Gustavo C Leal, Flávia Vieira, Ana Paula Jesus-Nunes, Rodrigo P Mello, Guilherme Magnavita, Ana Teresa Caliman-Fontes, Mariana V F Echegaray, Igor D Bandeira, Samantha S Silva, Diogo E Cavalcanti, Lucas Araújo-de-Freitas, Luciana M Sarin, Marco A Tuena, Carolina Nakahira, Aline S Sampaio, José A Del-Porto, Gustavo Turecki, Colleen Loo, Lacerda Acioly L T ALT Department of Psychiatry, Federal University of São Paulo, São Paulo, Brazil; Interdisciplinary Laboratory of Clinical Neurosciences, Federal Unive, and Lucas C Quarantini.
• Laboratory of Neuropsychopharmacology, Federal University of Bahia, Salvador, Brazil; Postgraduate Program in Medicine and Health, Medical School of Bahia, Federal University of Bahia, Salvador, Brazil. Electronic address: lcq@ufba.br.
• J Affect Disord. 2020 Mar 1; 264: 527-534.

BackgroundKetamine and its enantiomers have recently been highlighted as one of the most effective therapeutic options in refractory depression. However, racemic ketamine and esketamine have not been directly compared. The aim of this study is to assess the efficacy and safety of esketamine compared to ketamine in patients with treatment-resistant depression (TRD).MethodsThis is a randomized, double-blind, active-controlled, bicentre, non-inferiority clinical trial, with two parallel groups. Participants were randomly assigned to a 40-min single intravenous infusion of ketamine 0.5 mg/kg or esketamine 0.25 mg/kg. The primary outcome was the difference in remission rates for depression 24 h following intervention using the Montgomery-Åsberg Depression Rating Scale (MADRS), with a non-inferiority margin of 20%.Results63 subjects were included and randomly assigned (29 to receive ketamine and 34 to receive esketamine). At 24 h, 24.1% of participants in the ketamine group and 29.4% of participants in the esketamine group showed remission, with a difference of 5.3% (95% CILB -13.6%), confirming non-inferiority. MADRS scores improved from 33 (SD 9.3) to 16.2 (SD 10.7) in the ketamine group and from 33 (SD 5.3) to 17.5 (SD 12.2) in the esketamine one, with a difference of -5.27% (95% CILB, -13.6). Both groups presented similar mild side effects.ConclusionsEsketamine was non-inferior to ketamine for TRD 24 h following infusion. Both treatments were effective, safe, and well tolerated.Trial RegistrationRegistered in Japan Primary Registries Network: UMIN000032355.Copyright © 2019 Elsevier B.V. All rights reserved.

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