A Study to Evaluate the Efficacy and Safety of Intranasal Esketamine in Addition to Comprehensive Standard of Care for the Rapid Reduction of the Symptoms of Major Depressive Disorder, Including Suicidal Ideation, in Adult Participants Assessed to be at Imminent Risk for Suicide (ASPIRE II)
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.
Details
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.