A Randomized, Double-blind, Multicenter Active-controlled Study to Evaluate the Efficacy, Pharmacokinetics, Safety and Tolerability of Flexible Doses of Intranasal Esketamine Plus an Oral Antidepressant in Adult Subjects With Treatment-resistant Depression
Phase of Trial: Phase III
Latest Information Update: 01 Aug 2018
At a glance
- Drugs Esketamine (Primary) ; Duloxetine; Escitalopram; Sertraline; Venlafaxine
- Indications Major depressive disorder
- Focus Registrational; Therapeutic Use
- Sponsors Janssen Research & Development
- 29 Jun 2018 Planned End Date changed from 31 Dec 2021 to 28 Apr 2021.
- 22 Jun 2018 Status changed from not yet recruiting to recruiting.
- 19 Jun 2018 Primary endpoint has been met. (Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at End of Double-blind Treatment Phase (Week 4)), as reported in a Janssen Media Release.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History