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Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT03185819
Study type Interventional
Source Janssen Research & Development, LLC
Contact Study Contact
Phone 844-434-4210
Status Recruiting
Phase Phase 2
Start date October 5, 2017
Completion date February 4, 2022

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