European Archives of Psychiatry and Clinical Neuroscience
February 20, 2020
G. C. Leal, I. D. Bandeira, F. S. Correia-Melo et al.
257 citations
A single intravenous infusion of arketamine (0.5 mg/kg) rapidly reduced depression severity in seven people with treatment-resistant depression. The Montgomery–Åsberg Depression Rating Scale score fell from an average of 30.7 before infusion to 10.4 after one day, a mean drop of 20.3 points. Dissociative side effects were nearly absent. The findings suggest arketamine may produce fast-onset and sustained antidepressant effects with a favorable safety profile, as previously observed in animals, but controlled trials are needed to confirm.
Journal of Affective Disorders
November 14, 2019
F. S. Correia-Melo, G. C. Leal, F. Vieira et al.
188 citations
In adults with treatment-resistant depression, a single intravenous infusion of esketamine (0.25 mg/kg) was non-inferior to ketamine (0.5 mg/kg) for achieving remission 24 hours later. Among 63 participants, 29.4% in the esketamine group and 24.1% in the ketamine group showed remission, a difference of 5.3% that fell within the predefined non-inferiority margin. Depression scores on the Montgomery-Åsberg Depression Rating Scale improved similarly in both groups, and side effects were mild and comparable. The findings suggest that esketamine at half the dose of ketamine offers equivalent short-term efficacy and safety.
Medicine
September 1, 2018
Fernanda S. Correia-Melo, Gustavo C. Leal, Michelle S. Carvalho et al.
61 citations
A protocol describes a planned randomized, controlled, double-blind noninferiority trial comparing a single infusion of esketamine (0.25 mg/kg) with racemic ketamine (0.5 mg/kg) for treatment-resistant depression. The primary outcome is remission rates at 24 and 72 hours after infusion. Secondary outcomes include cognition, dissociation, and blood biomarkers. The authors state that no study has directly compared these two forms, and a head-to-head test is needed to see if esketamine is comparable in efficacy and safety.
Journal of Psychiatric Research
August 1, 2023
Igor D. Bandeira, Gustavo C. Leal, Fernanda S. Correia-Melo et al.
In a pilot trial of six people with bipolar I or II disorder who had been depressed for at least four weeks, two intravenous infusions of arketamine (0.5 mg/kg followed one week later by 1 mg/kg) rapidly reduced depression severity. Depression scores on the Montgomery-Åsberg Depression Rating Scale fell from a baseline mean of 36.66 to 27.83 one day after the first infusion and from 32.0 to 17.66 one day after the second infusion. The drug was well tolerated with almost no dissociation and no manic symptoms. The findings suggest arketamine has rapid-acting antidepressant properties for bipolar depression, consistent with earlier animal research on major depression.
Journal of Affective Disorders
June 1, 2023
Gustavo C. Leal, Breno Souza-Marques, Rodrigo P Mello et al.
In a small pilot trial, the antidepressant arketamine was compared with placebo for treatment-resistant depression. Ten participants received both arketamine (0.5 mg/kg) and saline one week apart in a randomized, double-blind, crossover design. Depression improved over time, but there was no significant difference between arketamine and placebo. Dissociation and other adverse events were minimal. The study was underpowered, and the authors conclude that arketamine was not superior to placebo but was extremely safe, recommending larger trials with different dosing strategies.