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Title

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

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.

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.

Subjects

DRUG efficacy; MENTAL depression; INTRAVENOUS therapy; PILOT projects

Publication

European Archives of Psychiatry & Clinical Neuroscience, 2021, Vol 271, Issue 3, p577

ISSN

0940-1334

Publication type

Academic Journal

DOI

10.1007/s00406-020-01110-5

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