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Introduction: Major depressive disorder (MDD) is associated with an elevated rate of mortality, primarily due to suicide. The risk of suicide in those with MDD is about 20 times that of the general population, with over half of all suicides occurring in depressed individuals. While conventional antidepressants are often effective in treating depressive symptoms including suicidal ideation (SI), their delayed onset of action significantly limits their utility in the treatment of patients with MDD who are at imminent risk of for suicide. 
 
Methods: PeRSEVERe is a 12-week, randomized, double-blind, placebo-controlled study of intranasal esketamine in subjects with MDD who are assessed to be at imminent risk for suicide. The primary objective is to evaluate the efficacy of intranasal esketamine 84 mg compared with intranasal placebo in reducing the symptoms of MDD including SI.
 
Results: Of the 68 patients randomized, 49 (ESK: 27; placebo: 22) completed the DB treatment phase. Mean (SD) baseline MADRS total scores were: 38.5 (6.17) and 38.8 (7.02) for the ESK and placebo groups, respectively. The primary endpoint, change from baseline in MADRS total score at day 1 (4 hours postdose) was significantly greater for ESK treatment vs placebo (p=0.015). Secondary endpoint findings showed significantly greater change from baseline in MADRS total score at day 2 for ESK treatment vs placebo (p=0.015). The ESK group showed significantly greater improvement vs placebo in the MADRS suicide item at day 1 (4 hours postdose; p=0.002). A greater proportion of patients in ESK group achieved resolution of suicide risk (CGJ-SR score of 0 or 1) vs placebo at 4 hours (21.2% vs 9.7%) and day 2 (40% vs 6.5%). The response rate at day 2 was higher in ESK group (54.3%; 19/35) vs placebo group (29%). Similarly, the remission rate at day 2 was higher for patients treated with ESK (34.3%) vs placebo (16.1%). Treatment with intranasal ESK 84 mg was generally tolerated.
 
Conclusions: In patients with MDD who were assessed to be at imminent risk for suicide, intranasal esketamine demonstrated statistically significant and clinically meaningful effects in reducing depressive symptoms compared with placebo at 4 hours (day 1) and ~24 hours (day 2) after initial dose. A significant improvement in suicidality (MADRS suicide item and CGJ-SR from SIBAT) was also observed at these time points. Moreover, intranasal ESK treatment exhibited rapid onset of response and greater likelihood of remission in this vulnerable population. 

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