Intravenous arketamine for treatment-resistant depression: open-label pilot study

We aimed to analyze the efficacy and safety of arketamine, the R (−)-enantiomer of ketamine, for treatment-resistant depression (TRD) in humans. Open-label pilot trial, seven subjects with TRD received a single intravenous infusion of arketamine (0.5 mg/kg); primary outcome was change in Montgomery–...

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Published inEuropean archives of psychiatry and clinical neuroscience Vol. 271; no. 3; pp. 577 - 582
Main Authors Leal, Gustavo C., Bandeira, Igor D., Correia-Melo, Fernanda S., Telles, Manuela, Mello, Rodrigo P., Vieira, Flavia, Lima, Cassio S., Jesus-Nunes, Ana Paula, Guerreiro-Costa, Lívia N. F., Marback, Roberta F., Caliman-Fontes, Ana Teresa, Marques, Breno L. S., Bezerra, Marília L. O., Dias-Neto, Alberto L., Silva, Samantha S., Sampaio, Aline S., Sanacora, Gerard, Turecki, Gustavo, Loo, Colleen, Lacerda, Acioly L. T., Quarantini, Lucas C.
Format Journal Article
LanguageEnglish
Published Berlin/Heidelberg Springer Berlin Heidelberg 01.04.2021
Springer Nature B.V
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Online AccessGet full text
ISSN0940-1334
1433-8491
1433-8491
DOI10.1007/s00406-020-01110-5

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Abstract We aimed to analyze the efficacy and safety of arketamine, the R (−)-enantiomer of ketamine, for treatment-resistant depression (TRD) in humans. Open-label pilot trial, seven subjects with TRD received a single intravenous infusion of arketamine (0.5 mg/kg); primary outcome was change in Montgomery–Åsberg Depression Rating Scale (MADRS) 24 h after. Mean MADRS dropped from 30.7 before infusion to 10.4 after one day, a mean difference of 20.3 points [CI 95% 13.6–27.0; p  < 0.001]; dissociation was nearly absent. Arketamine might produce fast-onset and sustained antidepressant effects in humans with favorable safety profile, like previously reported with animals; further controlled-trials are needed.
AbstractList We aimed to analyze the efficacy and safety of arketamine, the R(-)-enantiomer of ketamine, for treatment-resistant depression (TRD) in humans. Open-label pilot trial, seven subjects with TRD received a single intravenous infusion of arketamine (0.5 mg/kg); primary outcome was change in Montgomery-Åsberg Depression Rating Scale (MADRS) 24 h after. Mean MADRS dropped from 30.7 before infusion to 10.4 after one day, a mean difference of 20.3 points [CI 95% 13.6-27.0; p < 0.001]; dissociation was nearly absent. Arketamine might produce fast-onset and sustained antidepressant effects in humans with favorable safety profile, like previously reported with animals; further controlled-trials are needed.
We aimed to analyze the efficacy and safety of arketamine, the R(-)-enantiomer of ketamine, for treatment-resistant depression (TRD) in humans. Open-label pilot trial, seven subjects with TRD received a single intravenous infusion of arketamine (0.5 mg/kg); primary outcome was change in Montgomery-Åsberg Depression Rating Scale (MADRS) 24 h after. Mean MADRS dropped from 30.7 before infusion to 10.4 after one day, a mean difference of 20.3 points [CI 95% 13.6-27.0; p < 0.001]; dissociation was nearly absent. Arketamine might produce fast-onset and sustained antidepressant effects in humans with favorable safety profile, like previously reported with animals; further controlled-trials are needed.We aimed to analyze the efficacy and safety of arketamine, the R(-)-enantiomer of ketamine, for treatment-resistant depression (TRD) in humans. Open-label pilot trial, seven subjects with TRD received a single intravenous infusion of arketamine (0.5 mg/kg); primary outcome was change in Montgomery-Åsberg Depression Rating Scale (MADRS) 24 h after. Mean MADRS dropped from 30.7 before infusion to 10.4 after one day, a mean difference of 20.3 points [CI 95% 13.6-27.0; p < 0.001]; dissociation was nearly absent. Arketamine might produce fast-onset and sustained antidepressant effects in humans with favorable safety profile, like previously reported with animals; further controlled-trials are needed.
We aimed to analyze the efficacy and safety of arketamine, the R (−)-enantiomer of ketamine, for treatment-resistant depression (TRD) in humans. Open-label pilot trial, seven subjects with TRD received a single intravenous infusion of arketamine (0.5 mg/kg); primary outcome was change in Montgomery–Åsberg Depression Rating Scale (MADRS) 24 h after. Mean MADRS dropped from 30.7 before infusion to 10.4 after one day, a mean difference of 20.3 points [CI 95% 13.6–27.0; p  < 0.001]; dissociation was nearly absent. Arketamine might produce fast-onset and sustained antidepressant effects in humans with favorable safety profile, like previously reported with animals; further controlled-trials are needed.
We aimed to analyze the efficacy and safety of arketamine, the R(−)-enantiomer of ketamine, for treatment-resistant depression (TRD) in humans. Open-label pilot trial, seven subjects with TRD received a single intravenous infusion of arketamine (0.5 mg/kg); primary outcome was change in Montgomery–Åsberg Depression Rating Scale (MADRS) 24 h after. Mean MADRS dropped from 30.7 before infusion to 10.4 after one day, a mean difference of 20.3 points [CI 95% 13.6–27.0; p < 0.001]; dissociation was nearly absent. Arketamine might produce fast-onset and sustained antidepressant effects in humans with favorable safety profile, like previously reported with animals; further controlled-trials are needed.
Author Lima, Cassio S.
Quarantini, Lucas C.
Marques, Breno L. S.
Guerreiro-Costa, Lívia N. F.
Sanacora, Gerard
Sampaio, Aline S.
Mello, Rodrigo P.
Caliman-Fontes, Ana Teresa
Dias-Neto, Alberto L.
Lacerda, Acioly L. T.
Telles, Manuela
Bezerra, Marília L. O.
Loo, Colleen
Silva, Samantha S.
Bandeira, Igor D.
Leal, Gustavo C.
Correia-Melo, Fernanda S.
Jesus-Nunes, Ana Paula
Marback, Roberta F.
Turecki, Gustavo
Vieira, Flavia
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Keywords Rapid-acting antidepressant
(
Ketamine
Arketamine
Major depressive disorder
Treatment-resistant depression
(R)-Ketamine
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Snippet We aimed to analyze the efficacy and safety of arketamine, the R (−)-enantiomer of ketamine, for treatment-resistant depression (TRD) in humans. Open-label...
We aimed to analyze the efficacy and safety of arketamine, the R(-)-enantiomer of ketamine, for treatment-resistant depression (TRD) in humans. Open-label...
We aimed to analyze the efficacy and safety of arketamine, the R(−)-enantiomer of ketamine, for treatment-resistant depression (TRD) in humans. Open-label...
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SubjectTerms Enantiomers
Intravenous administration
Ketamine
Medicine
Medicine & Public Health
Mental depression
Neurosciences
Psychiatry
Short Communication
Treatment resistance
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Title Intravenous arketamine for treatment-resistant depression: open-label pilot study
URI https://link.springer.com/article/10.1007/s00406-020-01110-5
https://www.ncbi.nlm.nih.gov/pubmed/32078034
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