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https://www.arca.fiocruz.br/handle/icict/30736
COMPARATIVE STUDY OF ESKETAMINE AND RACEMIC KETAMINE IN TREATMENT-RESISTANT DEPRESSION: PROTOCOL FOR A NON-INFERIORITY CLINICAL TRIAL
Depressão
Esketamina
Isomerismo
Cetamina
Resistente ao tratamento
Author
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.
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.
Affilliation
Múltipla - ver em Notas
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.
Keywords in Portuguese
Ensaio clínicoDepressão
Esketamina
Isomerismo
Cetamina
Resistente ao tratamento
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