Study to Evaluate the Efficacy and Safety of 3 Fixed Doses 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 Pediatric Participants Assessed to be at Imminent Risk for Suicide
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.
Details
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.