Intravenous arketamine for treatment-resistant depression: open-label pilot study
Bandeira, I. D., Bezerra, M. L. O., Caliman-Fontes, A. T., Correia-Melo, F. S., Dias-Neto, A. L., Guerreiro-Costa, L. N. F., Jesus-Nunes, A. P., Lacerda, A. L. T., Leal, G. C., Lima, C. S., Loo, C., Marback, R. F., Marques, B. L. S., Mello, R. P., Quarantini, L. C., Sampaio, A. S., Sanacora, G., Silva, S. S., Turecki, G., Vieira, F.
This open-label study (n=7) study investigated the antidepressant efficacy of (R-)ketamine (35mg/70kg), which has been implicated by animal studies to be more potent and longer-lasting compared to (S-)ketamine. Results demonstrate (R-)ketamine's ability to produce a fast and robust antidepressant effect in patients with depression, with potentially greater and longer-lasting effects, greater response rate, and a lower remission rate than effects reported for (S-)ketamine, although this study had a small sample size and lacked placebo-control.
Abstract
Introduction: We aimed to analyze the efcacy and safety of arketamine, the R(−)-enantiomer of ketamine, for treatment-resistant depression (TRD) in humans.Methods: 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.Results: Mean MADRS dropped from 30.7 before infusion to 10.4 after one day, a mean diference of 20.3 points [CI 95% 13.6-27.0; p<0.001]; dissociation was nearly absent.Discussion: Arketamine might produce fast-onset and sustained antidepressant efects in humans with favorable safety profle, like previously reported with animals; further controlled-trials are needed.