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

Gustavo C. Leal, Igor D. Bandeira, Fernanda S. Correia-Melo, Manuela Telles, Rodrigo P Mello, Flávia Vieira, Cássio S. Lima, A. P. Jesus-Nunes, Lívia N F Guerreiro-Costa, Roberta F. Marback, A. T. Caliman-Fontes, Breno L. S. Marques, M. L. O. Bezerra, A. Dias-Neto, Samantha S. Silva, A. Sampaio, Gerard Sanacora, Gustavo Turecki, Colleen Loo, Acioly L T Lacerda, Lucas C Quarantini

European Archives of Psychiatry and Clinical Neuroscience February 20, 2020 DOI: 10.1007/s00406-020-01110-5 (opens in new tab)

Study at a glance

AI-extracted from the abstract
Characteristics Open-label pilot trial Pilot study Peer reviewed
Sample size 7
Population Humans with treatment-resistant depression
Intervention Arketamine
Dose 0.5 mg/kg
Duration 24 hours
Topics Depression Ketamine
Citations 257
Key findings A single intravenous infusion of arketamine produced a rapid and substantial reduction in depression severity, with minimal dissociative side effects, in seven people with treatment-resistant depression.

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.