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A Randomized, Double-blind, Multicenter, Active-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Intranasal Esketamine Plus an Oral Antidepressant in Elderly Subjects With Treatment-resistant Depression

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Trial Profile

A Randomized, Double-blind, Multicenter, Active-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Intranasal Esketamine Plus an Oral Antidepressant in Elderly Subjects With Treatment-resistant Depression

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 14 Feb 2025

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At a glance

  • Drugs Esketamine (Primary) ; Duloxetine; Escitalopram; Sertraline; Venlafaxine
  • Indications Major depressive disorder
  • Focus Registrational; Therapeutic Use
  • Acronyms TRANSFORM-3
  • Sponsors Janssen Research & Development

    • Most Recent Events

    • 07 Jul 2021 Results assessing impact of long-term intermittent treatment with esketamine by using four studies (TRANSFORM-1, TRANSFORM-2, TRANSFORM-3 and SUSTAIN-1) published in the CNS Drugs.
    • 29 Aug 2020 Results of post hoc analysis of data from TRANSFORM 1,2,3 and SUSTAIN 1 study assessing the benefit risk profile of esketamine nasal spray plus oral antidepressant induction and maintenance treatment in patients with treatment resistant depression published in the Clinical Pharmacology and Therapeutics
    • 07 Jul 2020 Results, pooled analysis of data from phase 3 studies of Esketamine assessing its cost effectiveness, published in the Psychiatric Services

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