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

Trial Profile

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

Recruiting
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
  • Most Recent Events

    • 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.
Restricted Access

Oops, it looks like you don’t have a valid subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • with a username/password associated to an account with a valid subscription
  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Request a trial

If you are a subscriber to this content then contact us at AsktheExpert.AdisInsight@springer.com so we can help.

Back to top