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A Randomized, Double-blind, Multicenter, Active-Controlled Study of Intranasal Esketamine Plus an Oral Antidepressant for Relapse Prevention in Treatment-resistant Depression

Trial Profile

A Randomized, Double-blind, Multicenter, Active-Controlled Study of Intranasal Esketamine Plus an Oral Antidepressant for Relapse Prevention in Treatment-resistant Depression

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 27 Sep 2022

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At a glance

  • Drugs Esketamine (Primary) ; Duloxetine; Escitalopram; Sertraline; Venlafaxine
  • Indications Major depressive disorder
  • Focus Registrational; Therapeutic Use
  • Acronyms SUSTAIN-1
  • Sponsors Janssen Research & Development; Janssen-Cilag
  • Most Recent Events

    • 19 Sep 2022 Results of post hoc and pooled analysis from NCT02493868 and NCT02497287 describing the tolerability of esketamine nasal spray based on the adverse event profile observed during treatment sessions occurring early and later over the course of treatment, published in the Journal of Clinical Psychiatry
    • 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.
    • 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.
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