Key clinical point: Esketamine nasal spray appears to rapidly reduce depressive symptoms in severely ill patients with major depressive disorder (MDD) who have active suicidal ideation with intent.
Major finding: Esketamine plus standard of care vs. placebo plus standard of care was associated with greater improvement in Montgomery-Asberg Depression Rating Scale total score at 24 hours (least-squares [LS] mean difference, −3.9; 95% confidence interval [CI], −6.60 to −1.11). This was also noted at the earlier (4-hour) timepoint (LS mean difference, −4.2; 95% CI, −6.38 to −1.94).
Study details: In this ASPIRE II trial, 230 MDD patients having active suicidal ideation with intent were randomly assigned (1:1) to receive esketamine nasal spray plus standard of care or placebo plus standard of care.
Disclosures: The study was funded by Janssen Research and Development, LLC. Dr. Ionescu, Dr. Fu, Dr. Qiu, Dr. Lim, Dr. Hough, Dr. Drevets, Dr. Manji, Dr. Canuso, and Ms. Lane are employees of Janssen Research & Development, LLC. Dr. Manji is an inventor on patents that are directed to this technology; are assigned to Icahn School of Medicine at Mount Sinai, Yale University, and NIH; and are exclusively licensed to Janssen. However, he does not receive any direct financial benefit therefrom. Dr. Kasper received grants/research support, consulting fees, and/or honoraria from various pharmaceutical companies.
Ionescu DF et al. Int J Neuropsychopharmacol. 2020 Aug 29. doi: 10.1093/ijnp/pyaa068.