Esketamine Nasal Spray for Rapid Reduction of Depressive Symptoms in Patients With Major Depressive Disorder Who Have Active Suicide Ideation With Intent: Results of a Phase 3, Double-Blind, Randomized Study (ASPIRE II)
The International Journal of Neuropsychopharmacology August 26, 2020 Dawn F. Ionescu, Dong-Jing Fu, Xin Qiu et al. 411 citations
In severely depressed adults with active suicidal thoughts and intent, adding esketamine nasal spray to standard care (hospitalization and new antidepressants) produced a greater reduction in depressive symptoms than placebo plus standard care. At 24 hours, depression scores dropped an average of 15.7 points with esketamine versus 12.4 points with placebo. Improvement was also seen at 4 hours. Both groups showed rapid decreases in suicidality severity, but the difference between them was not statistically significant. Common side effects of esketamine included dizziness, dissociation, nausea, and headache.