NCT03185819

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 147 (actual)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: 9 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study will enroll participants with major depressive disorder (MDD) presenting with suicidal ideation who are assessed to be at imminent risk for suicide. The study will be conducted in 4 phases: a screening evaluation performed within 48 hours prior to Day 1 intranasal dose; a 25-day double-blind treatment phase (Days 1-25); an 8-week initial post-treatment phase (Days 25-81); and a subsequent phase to complete a full 6-month post-treatment follow-up (Days 81-200). Efficacy, safety, pharmacokinetic, biomarker, and pharmacogenomic evaluations will be performed in the study at defined schedule. The duration of the participant's participation will be approximately 29 weeks. If you or a loved one are having thoughts of suicide, please seek immediate medical help. Go to the emergency room or call the National Suicide Prevention Lifeline at 1-800-273-8255.

Conditions

• Depressive Disorder, Major

Interventions

Type	Name	Description
DRUG	Intranasal Placebo	Participants will receive placebo as intranasal dose to match intranasal esketamine.
DRUG	Midazolam Placebo Solution	Participants will receive placebo as oral dose to match midazolam drug.
DRUG	Midazolam	Participants will receive midazolam solution 0.125 mg/kg as oral dose to match placebo.
DRUG	Esketamine	Participants will receive esketamine at a dose of 28 mg as intranasal solution.
DRUG	Esketamine	Participants will receive esketamine at a dose of 56 mg as intranasal solution.
DRUG	Esketamine	Participants will receive esketamine at a dose of 84 mg as intranasal solution.

Timeline

• Start date: 2017-10-05
• Primary completion: 2023-03-31
• Completion: 2023-03-31
• First posted: 2017-06-14
• Last updated: 2025-04-29
• Results posted: 2024-04-17

Locations

51 sites across 9 countries: United States, Belgium, Brazil, Bulgaria, France, Hungary, Italy, Poland, Spain

Regulatory

• FDA-regulated drug study