At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Double-blind, Randomized, Psychoactive Placebo-controlled, Study to Evaluate 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 the Rapid Reduction of the Symptoms of Major Depressive Disorder, Including Suicidal Ideation, in Pediatric Subjects Assessed to be at Imminent Risk for Suicide
In Brief
A Phase 2 clinical trial evaluating Intranasal Placebo, Midazolam Placebo Solution, and 2 other interventions for Depressive Disorder, Major. Completed, enrolled 147 participants across 51 sites in 9 countries.
Detailed Summary
The purpose of this study is to assess the efficacy of a single (first) dose of 3 fixed doses of intranasal esketamine {28 milligram (mg), 56 mg, and 84 mg} compared with psychoactive placebo (oral midazolam) in rapidly reducing the symptoms of major depressive disorder (MDD) including suicidal ideation in participants 12 to less than 18 years of age who are assessed to be at imminent risk for suicide.
Study Details
Timeline
Interventions
Participants will receive placebo as intranasal dose to match intranasal esketamine.
Participants will receive placebo as oral dose to match midazolam drug.
Participants will receive midazolam solution 0.125 mg/kg as oral dose to match placebo.
Participants will receive esketamine at a dose of 28 mg as intranasal solution.
Participants will receive esketamine at a dose of 56 mg as intranasal solution.
Participants will receive esketamine at a dose of 84 mg as intranasal solution.