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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

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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

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 29 Apr 2024

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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

    • 30 Apr 2021 Status changed from active, no longer recruiting to completed.
    • 03 Mar 2021 Planned End Date changed from 28 Apr 2021 to 21 Apr 2021.
    • 03 Mar 2021 Planned primary completion date changed from 28 Apr 2021 to 21 Apr 2021.

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