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.
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.
Intranasal esketamine 84 mg plus standard of care antidepressant treatment, administered twice weekly for 4 weeks (8 doses).
Days 1,4,8,11,15,18,22,25 (8 doses over 4 weeks).
Standard of care antidepressant treatment (monotherapy or augmentation) as determined by treating physician, initiated Day 1.
Intranasal placebo plus standard of care antidepressant treatment, administered twice weekly for 4 weeks (8 doses).
Intranasal placebo on Days 1,4,8,11,15,18,22,25.
Standard of care antidepressant treatment (monotherapy or augmentation) as determined by treating physician, initiated Day 1.
Pooled data from ASPIRE I and II indicate that esketamine nasal spray plus standard of care produced greater patient‑reported improvements in health‑related quality of life and treatment satisfaction than placebo plus standard of care in adults with major depressive disorder and active suicidal ideation. The benefit was statistically significant on the QLDS (LS mean difference −3.1, 95% CI −5.21 to −1.02), with non‑significant change on the Beck Hopelessness Scale and favourable trends on EQ‑5D‑5L indices and TSQM‑9 domains.