This double-blind, randomized, placebo-controlled trial (n=226) aimed to assess the efficacy and safety of intranasal esketamine 84 milligrams (mg) in addition to comprehensive standard care for rapidly reducing Major Depressive Disorder (MDD) symptoms, including suicidal ideation, in adults at imminent risk for suicide.
Randomized, double-blind, parallel-group Phase 3 study comparing intranasal esketamine 84 mg plus comprehensive standard of care versus intranasal placebo plus standard of care in adults hospitalised for imminent suicide risk; primary efficacy measured by change in MADRS total score at 24 hours post first dose.
Dosing: esketamine or placebo administered intranasally on Days 1, 4, 8, 11, 15, 18, 22 and 25 (8 administrations total); standard of care antidepressant therapy initiated on Day 1; participants typically hospitalised for at least 14 days per protocol.
Intranasal esketamine 84 mg twice weekly for 4 weeks plus standard of care antidepressant therapy.
Intranasal administration on Days 1, 4, 8, 11, 15, 18, 22, and 25.
Standard of care antidepressant therapy determined by treating physician; initiated on Day 1.
Intranasal placebo twice weekly for 4 weeks plus standard of care antidepressant therapy.
Intranasal placebo on Days 1, 4, 8, 11, 15, 18, 22, and 25.
Standard of care antidepressant therapy determined by treating physician; initiated on Day 1.