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

What is the purpose of this trial?

Brief 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.


Participation Guidelines

Ages: 12 - 17 years

Gender: Both


Janssen Research & Development, LLC

Start Date: 04/17/2018

End Date: 10/07/2021

Last Updated: 05/07/2019

Study HIC#: 2000022059

Get Involved

For more information about this study, contact:
Angie Landeros-Weisenberger
+1 203-737-4809
angeli.landeros@yale.edu

If you would prefer to contact a member of the Help us Discover team about this trial and other similar trials, please email helpusdiscover@yale.edu or call 1-877-978-8348.

Investigators

Michael Bloch

Principal Investigator

Sub-Investigators