Safety of Intranasal Esketamine for the Rapid Reduction of Symptoms of Depression and Suicidality in Patients at Imminent Risk for Suicide : Results of a Double-Blind , Randomized , Placebo-Controlled Study

Method: In a double-blind, multicenter, proof-of-concept study, 68 participants were randomly assigned to receive esketamine (84 mg) or placebo twice weekly for 4 weeks, in addition to comprehensive standard-of-care treatment. The primary efficacy endpoint was change in score from baseline to 4 hours after initial dose on the Montgomery-Åsberg Depression Rating Scale (MADRS). Clinician global judgment of suicide risk (fromtheSuicide IdeationandBehaviorAssessment Tool) was also assessed. Secondary endpoints included these measures at 24 hours and double-blind endpoint at day 25.