Results Sixty-seven participants (38 women, mean [SD] age,  years) were included in the efficacy and safety analyses. Change (least squares mean [SE] difference vs placebo) in MADRS total score (both periods combined) in all 3 esketamine groups was superior to placebo (esketamine 28 mg: − , P = .02; 56 mg: − , P = .001; 84 mg: − , P < .001), with a significant ascending dose-response relationship ( P < .001). Improvement in depressive symptoms appeared to be sustained (− ) despite reduced dosing frequency in the open-label phase. Three of 56 (5%) esketamine-treated participants during the double-blind phase vs none receiving placebo and 1 of 57 participants (2%) during the open-label phase had adverse events that led to study discontinuation (1 event each of syncope, headache, dissociative syndrome, and ectopic pregnancy).
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