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A Randomized, Double-blind, Multicenter, Active-controlled Study to Evaluate the Efficacy, 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, 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: 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-2
  • Sponsors Janssen Research & Development

Most Recent Events

  • 01 May 2023 Results of post hoc exploratory pooled analysis assessing to compare the esketamine nasal spray plus a newly initiated oral antidepressant (ESK+AD; n = 310) with a newly initiated oral AD plus placebo nasal spray (AD+PBO; n = 208) in patients with treatment-resistant depression from NCT02417064 and NCT02418585 studies, published in the Psychiatry Research.
  • 20 Apr 2022 Results of a post hoc analysis assessed which symptoms measured by the Patient Health Questionnaire and Montgomery-Asberg Depression Rating Scale improve in those treated with esketamine nasal spray in combination with oral antidepressant (AD) compared with those treated with placebo plus AD for adult patients with treatment-resistant depression the published in the CNS Drugs
  • 12 Jan 2022 Results of post hoc analysis data from phase 3 trials (TRANSFORM-1, TRANSFORM-2 and SUSTAIN-1) assessing the relationship between dissociation and antidepressant effects of esketamine nasal spray, published in the International Journal of Neuropsychopharmacology.

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