Trial Profile

A Randomized, Double-Blind, Active-Controlled, International, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Flexibly-dosed Esketamine Nasal Spray Plus a New Standard-of-care Oral Antidepressant or Placebo Nasal Spray Plus a New Standard-of-care Oral Antidepressant in Adult and Elderly Participants With Treatment-resistant Depression

Status: Withdrawn prior to enrolment

Phase of Trial: Phase III

Latest Information Update: 05 Feb 2025

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At a glance

Drugs Esketamine (Primary) ; Agomelatine; Bupropion; Duloxetine; Escitalopram; Mirtazapine; Sertraline; Trazodone
Indications Major depressive disorder
Focus Registrational; Therapeutic Use
Sponsors Janssen-Cilag

22 Nov 2019 Status changed from not yet recruiting to withdrawn prior to enrolment.
20 Sep 2019 Planned initiation date changed from 1 Sep 2019 to 1 Dec 2019.
26 Jul 2019 Planned initiation date changed from 22 May 2019 to 1 Sep 2019.

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