This double-blind, randomized, psychoactive placebo-controlled trial (n=147) assessed the efficacy and safety of 3 fixed doses (28 mg, 56 mg, and 84 mg) of intranasal esketamine in addition to comprehensive standard of care for rapidly reducing the symptoms of major depressive disorder (MDD), including suicidal ideation, in pediatric subjects.
Randomized, double-blind, parallel-group Phase II study in paediatric participants with MDD and imminent suicide risk comparing intranasal esketamine (28, 56, 84 mg) plus standard care versus psychoactive placebo (oral midazolam) with intranasal placebo.
Primary assessments focused on rapid reduction of depressive and suicidal symptoms after dosing; safety, pharmacokinetic, biomarker, and pharmacogenomic evaluations were performed across a 25-day double-blind phase and extended follow-up to 6 months.
Oral midazolam 0.125 mg/kg plus intranasal placebo matching esketamine.
Oral midazolam 0.125 mg/kg given 2x/week for 4 weeks (psychoactive placebo).
Intranasal placebo matched to esketamine; described as 3 intranasal doses.
Intranasal esketamine 84 mg plus oral placebo.
84 mg delivered as 6 x 14 mg sprays (3 per nostril) as described.
Oral placebo matching midazolam given 2x/week for 4 weeks.
Intranasal esketamine 56 mg plus oral placebo.
56 mg delivered as 4 x 14 mg sprays.
Oral placebo matching midazolam.
Intranasal esketamine 28 mg plus oral placebo.
28 mg delivered as 2 x 14 mg sprays.
Oral placebo matching midazolam.