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
Conditions
Mental Health & Behavioral Research
Phase II
Volunteers
Health Professionals
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.
- Ages12 years - 17 years
- GenderBoth
- Trial withJanssen Research & Development, LLC
- Start Date04/17/2018
- End Date10/07/2021
For more information about this study, contact:
Angie Landeros-Weisenberger
I'm interested in volunteering
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 877.978.8343
Principal Investigator
Sub-Investigators
- Last Updated07/15/2021
- Study HIC#2000022059