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 I)
Double-blind, randomised, placebo-controlled Phase III trial (n=226) testing intranasal esketamine 84 mg twice weekly for 4 weeks plus standard of care versus intranasal placebo plus standard of care for rapid reduction of MDD symptoms including suicidal ideation in adults at imminent suicide risk.
Details
Randomised, double-blind, placebo-controlled multicentre study evaluating intranasal esketamine 84 mg versus intranasal placebo, each given with comprehensive standard of care, in adults hospitalised for imminent suicide risk due to Major Depressive Disorder.
Primary outcome is change from baseline in MADRS total score at 24 hours post first dose; study includes a 25-day double-blind treatment phase (Days 1–25) and 65-day follow-up (Day 26–90), total ~13 weeks per participant.