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.
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.