Comparative study of esketamine and racemic ketamine in treatment-resistant depression: Protocol for a non-inferiority clinical trial
| Autor(a) principal: | |
|---|---|
| Data de Publicação: | 2018 |
| Outros Autores: | , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
| Tipo de documento: | Artigo |
| Idioma: | eng |
| Título da fonte: | Repositório Institucional da FIOCRUZ (ARCA) |
| Texto Completo: | https://www.arca.fiocruz.br/handle/icict/30736 |
Resumo: | 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. |
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Melo, Fernanda S. CorreiaLeal, Gustavo Carneiro GomesCarvalho, Michelle S.Nunes, Ana Paula JesusFerreira, Carolina B. N.Vieira, FláviaMagnavita, GuilhermeVale, Lucas A. S.Mello, Rodrigo P.Nakahira, CarolinaArgolo, Felipe C.Cardoso, TaniseSouza, Cezar D. S.Fontes, Ana Teresa CalimanFerreira, Marcelo B.Freitas, Lucas Araújo deTuena, Marco A.Echegaray, Mariana V. F.Cavalcanti, Diogo E.Lucchese, Ana C.Bandeira, Igor DoreaTelles, ManuelaLima, Cássio S.Sampaio, Aline SantosSilva, Samantha SiqueiraMarback, Roberta F.Del-Porto, José A.Abreu, José NeanderSarin, Luciana M.Paixão, Camilla SampaioCarvalho, Lucas Pedreira deMachado, Paulo Roberto LimaTurecki, GustavoLacerda, Acioly L. T.Quarantini, Lucas C.2018-12-21T16:45:26Z2018-12-21T16:45:26Z2018MELO, 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, 2018.0025-7974https://www.arca.fiocruz.br/handle/icict/3073610.1097/MD.0000000000012414Carvalho, 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.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.Múltipla - ver em NotasThe 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.engWillams & WilkinsEnsaio clínicoDepressãoEsketaminaIsomerismoCetaminaResistente ao tratamentoClinical trialDepressionEsketamineIsomerismKetamineTreatment resistantComparative study of esketamine and racemic ketamine in treatment-resistant depression: Protocol for a non-inferiority clinical trialinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articleinfo:eu-repo/semantics/openAccessreponame:Repositório Institucional da FIOCRUZ (ARCA)instname:Fundação Oswaldo Cruz (FIOCRUZ)instacron:FIOCRUZLICENSElicense.txtlicense.txttext/plain; charset=utf-82991https://www.arca.fiocruz.br/bitstream/icict/30736/1/license.txt5a560609d32a3863062d77ff32785d58MD51ORIGINALMelo FSC Comparative_study_of_esketamine_and_racemic.64.pdfMelo 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| dc.title.pt_BR.fl_str_mv |
Comparative study of esketamine and racemic ketamine in treatment-resistant depression: Protocol for a non-inferiority clinical trial |
| title |
Comparative study of esketamine and racemic ketamine in treatment-resistant depression: Protocol for a non-inferiority clinical trial |
| spellingShingle |
Comparative study of esketamine and racemic ketamine in treatment-resistant depression: Protocol for a non-inferiority clinical trial Melo, Fernanda S. Correia Ensaio clínico Depressão Esketamina Isomerismo Cetamina Resistente ao tratamento Clinical trial Depression Esketamine Isomerism Ketamine Treatment resistant |
| title_short |
Comparative study of esketamine and racemic ketamine in treatment-resistant depression: Protocol for a non-inferiority clinical trial |
| title_full |
Comparative study of esketamine and racemic ketamine in treatment-resistant depression: Protocol for a non-inferiority clinical trial |
| title_fullStr |
Comparative study of esketamine and racemic ketamine in treatment-resistant depression: Protocol for a non-inferiority clinical trial |
| title_full_unstemmed |
Comparative study of esketamine and racemic ketamine in treatment-resistant depression: Protocol for a non-inferiority clinical trial |
| title_sort |
Comparative study of esketamine and racemic ketamine in treatment-resistant depression: Protocol for a non-inferiority clinical trial |
| author |
Melo, Fernanda S. Correia |
| author_facet |
Melo, Fernanda S. Correia Leal, Gustavo Carneiro Gomes Carvalho, Michelle S. Nunes, Ana Paula Jesus Ferreira, Carolina B. N. Vieira, Flávia Magnavita, Guilherme Vale, Lucas A. S. Mello, Rodrigo P. Nakahira, Carolina Argolo, Felipe C. Cardoso, Tanise Souza, Cezar D. S. Fontes, Ana Teresa Caliman Ferreira, Marcelo B. Freitas, Lucas Araújo de Tuena, Marco A. Echegaray, Mariana V. F. Cavalcanti, Diogo E. Lucchese, Ana C. Bandeira, Igor Dorea Telles, Manuela Lima, Cássio S. Sampaio, Aline Santos Silva, Samantha Siqueira Marback, Roberta F. Del-Porto, José A. Abreu, José Neander Sarin, Luciana M. Paixão, Camilla Sampaio Carvalho, Lucas Pedreira de Machado, Paulo Roberto Lima Turecki, Gustavo Lacerda, Acioly L. T. Quarantini, Lucas C. |
| author_role |
author |
| author2 |
Leal, Gustavo Carneiro Gomes Carvalho, Michelle S. Nunes, Ana Paula Jesus Ferreira, Carolina B. N. Vieira, Flávia Magnavita, Guilherme Vale, Lucas A. S. Mello, Rodrigo P. Nakahira, Carolina Argolo, Felipe C. Cardoso, Tanise Souza, Cezar D. S. Fontes, Ana Teresa Caliman Ferreira, Marcelo B. Freitas, Lucas Araújo de Tuena, Marco A. Echegaray, Mariana V. F. Cavalcanti, Diogo E. Lucchese, Ana C. Bandeira, Igor Dorea Telles, Manuela Lima, Cássio S. Sampaio, Aline Santos Silva, Samantha Siqueira Marback, Roberta F. Del-Porto, José A. Abreu, José Neander Sarin, Luciana M. Paixão, Camilla Sampaio Carvalho, Lucas Pedreira de Machado, Paulo Roberto Lima Turecki, Gustavo Lacerda, Acioly L. T. Quarantini, Lucas C. |
| author2_role |
author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author |
| dc.contributor.author.fl_str_mv |
Melo, Fernanda S. Correia Leal, Gustavo Carneiro Gomes Carvalho, Michelle S. Nunes, Ana Paula Jesus Ferreira, Carolina B. N. Vieira, Flávia Magnavita, Guilherme Vale, Lucas A. S. Mello, Rodrigo P. Nakahira, Carolina Argolo, Felipe C. Cardoso, Tanise Souza, Cezar D. S. Fontes, Ana Teresa Caliman Ferreira, Marcelo B. Freitas, Lucas Araújo de Tuena, Marco A. Echegaray, Mariana V. F. Cavalcanti, Diogo E. Lucchese, Ana C. Bandeira, Igor Dorea Telles, Manuela Lima, Cássio S. Sampaio, Aline Santos Silva, Samantha Siqueira Marback, Roberta F. Del-Porto, José A. Abreu, José Neander Sarin, Luciana M. Paixão, Camilla Sampaio Carvalho, Lucas Pedreira de Machado, Paulo Roberto Lima Turecki, Gustavo Lacerda, Acioly L. T. Quarantini, Lucas C. |
| dc.subject.other.pt_BR.fl_str_mv |
Ensaio clínico Depressão Esketamina Isomerismo Cetamina Resistente ao tratamento |
| topic |
Ensaio clínico Depressão Esketamina Isomerismo Cetamina Resistente ao tratamento Clinical trial Depression Esketamine Isomerism Ketamine Treatment resistant |
| dc.subject.en.pt_BR.fl_str_mv |
Clinical trial Depression Esketamine Isomerism Ketamine Treatment resistant |
| 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. |
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2018 |
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2018-12-21T16:45:26Z |
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2018-12-21T16:45:26Z |
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2018 |
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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. |
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https://www.arca.fiocruz.br/handle/icict/30736 |
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0025-7974 |
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10.1097/MD.0000000000012414 |
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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. 0025-7974 10.1097/MD.0000000000012414 |
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Willams & Wilkins |
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Willams & Wilkins |
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