| Author | Melo, Fernanda S. Correia | |
| Author | Leal, Gustavo Carneiro Gomes | |
| Author | Carvalho, Michelle S. | |
| Author | Nunes, Ana Paula Jesus | |
| Author | Ferreira, Carolina B. N. | |
| Author | Vieira, Flávia | |
| Author | Magnavita, Guilherme | |
| Author | Vale, Lucas A. S. | |
| Author | Mello, Rodrigo P. | |
| Author | Nakahira, Carolina | |
| Author | Argolo, Felipe C. | |
| Author | Cardoso, Tanise | |
| Author | Souza, Cezar D. S. | |
| Author | Fontes, Ana Teresa Caliman | |
| Author | Ferreira, Marcelo B. | |
| Author | Freitas, Lucas Araújo de | |
| Author | Tuena, Marco A. | |
| Author | Echegaray, Mariana V. F. | |
| Author | Cavalcanti, Diogo E. | |
| Author | Lucchese, Ana C. | |
| Author | Bandeira, Igor Dorea | |
| Author | Telles, Manuela | |
| Author | Lima, Cássio S. | |
| Author | Sampaio, Aline Santos | |
| Author | Silva, Samantha Siqueira | |
| Author | Marback, Roberta F. | |
| Author | Del-Porto, José A. | |
| Author | Abreu, José Neander | |
| Author | Sarin, Luciana M. | |
| Author | Paixão, Camilla Sampaio | |
| Author | Carvalho, Lucas Pedreira de | |
| Author | Machado, Paulo Roberto Lima | |
| Author | Turecki, Gustavo | |
| Author | Lacerda, Acioly L. T. | |
| Author | Quarantini, Lucas C. | |
| Access date | 2018-12-21T16:45:26Z | |
| Available date | 2018-12-21T16:45:26Z | |
| Document date | 2018 | |
| Citation | MELO, Fernanda S. Correia et al. Comparative study of esketamine and racemic ketamine in treatment-resistant depression: Protocol for a non-inferiority clinical trial. Medicine, Baltimore, v. 97, n. 38, p. e12414, 2018. | pt_BR |
| ISSN | 0025-7974 | pt_BR |
| URI | https://www.arca.fiocruz.br/handle/icict/30736 | |
| Description | Carvalho, Lucas Pedreira de. Fundação Oswaldo Cruz. Instituto Gonçalo Moniz. Laboratório de Pesquisa Clínica. Salvador, BA, Brasil. a Postgraduate Program in Medicine and Health, b Psychiatry Service, University Hospital, Universidade Federal da Bahia, Salvador, c LiNC—Laboratório Interdisciplinar
de Neurociências Clínicas, d Depatment of Anesthesiology, e PRODAF—Programa de Transtornos Afetivos, Universidade Federal de São Paulo, São Paulo,
f Postgraduate Program in Psychology, Institute of Psychology, g Immunology Service, Universidade Federal da Bahial, h Clinical Research Laboratory (LAPEC), Gonçalo
Moniz Institute, Fiocruz-Bahia, Salvador, Brazil, i McGill Group for Suicide Studies, Douglas Mental Health University Institute & Department of Psychiatry, McGill
University, Montreal, Canada, j Center for Research and Clinical Trials Sinapse-Bairral, Instituto Bairral de Psiquiatria, Itapira, Brazil. | pt_BR |
| Sponsorship | Allergan and Lundbeck and research fees from Janssen Pharmaceutical during the last 12 months. ALTL has received
consulting fees from Janssen Pharmaceutical, Daiichi Sankyo Brasil, Cristalia Produtos Químicos e Farmacêuticos, Libbs Farmacêutica and SanofiAventis and has
received research fees from Eli Lilly, H. Lundbeck A/S, Servier Laboratories, Hoffman-La Roche and Forum Pharmaceuticals during the last 12 months. | pt_BR |
| Language | eng | pt_BR |
| Publisher | Willams & Wilkins | pt_BR |
| Rights | open access | pt_BR |
| Subject in Portuguese | Ensaio clínico | pt_BR |
| Subject in Portuguese | Depressão | pt_BR |
| Subject in Portuguese | Esketamina | pt_BR |
| Subject in Portuguese | Isomerismo | pt_BR |
| Subject in Portuguese | Cetamina | pt_BR |
| Subject in Portuguese | Resistente ao tratamento | pt_BR |
| Title | Comparative study of esketamine and racemic ketamine in treatment-resistant depression: Protocol for a non-inferiority clinical trial | pt_BR |
| Type | Article | pt_BR |
| DOI | 10.1097/MD.0000000000012414 | |
| Abstract | The use of ketamine as an option in the treatment of depressive disorder is growing rapidly, supported by numerous clinical trials attesting its efficacy and safety. Esketamine, the S (+) enantiomer of ketamine, is the most widely used form in the anesthetic environment in some countries, and new studies have shown that it may also be effective in depression and with better tolerability. However, no study so far has directly compared esketamine with racemic ketamine. Here we propose a protocol of a clinical trial to evaluate esketamine as a noninferior medicationMethods/design: This study protocol is for a randomized, controlled, double-blind noninferiority clinical trial. Subjects will be 18
years or older, with major depression characterized as treatment-resistant. Participants will receive a single infusion of either
esketamine (0.25mg/kg) or ketamine (0.5 mg/kg) over 40 minutes. The primary outcome will be the difference in remission rates
between the 2 treatment arms at 24 and 72hours after drug infusion. Secondary outcomes will include other timepoints,
measurements of cognition, dissociation, and blood biomarkers.
Discussion: A head-to-head study is the best way to evaluate whether the esketamine is in fact comparable to the racemic
ketamine in terms of both efficacy and safety, and, if positive, it would be an initial step to increase the access to that type of treatment
worldwide.
Ethics and dissemination: The study was approved by the local Institutional Review Board (University Hospital Professor
Edgard Santos—Federal University of Bahia—Number: 46657415.0.0000.0049). Subjects will only participate after voluntarily
agreeing and signing the Informed Consent Form. The study findings will be published in peer-reviewed journals and presented at
national and international conferences.
Trial registration: This trial has been registered in the Japan Primary Registries Network (JPRN): UMIN000032355, which is
affiliated with the World Health Organization. when compared to ketamine in the treatment of patients with treatment-resistant depression. | pt_BR |
| Affilliation | Múltipla - ver em Notas | pt_BR |
| Subject | Clinical trial | pt_BR |
| Subject | Depression | pt_BR |
| Subject | Esketamine | pt_BR |
| Subject | Isomerism | pt_BR |
| Subject | Ketamine | pt_BR |
| Subject | Treatment resistant | pt_BR |
