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
Phase of Trial: Phase II
Latest Information Update: 16 Jan 2019
At a glance
- Drugs Esketamine (Primary) ; Midazolam
- Indications Major depressive disorder
- Focus Therapeutic Use
- Sponsors Janssen Research & Development; Janssen-Cilag
- 31 May 2018 Planned End Date changed from 4 Feb 2022 to 7 Feb 2022.
- 04 May 2018 Status changed from suspended to recruiting.
- 05 Apr 2018 Status changed from recruiting to suspended.