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Randomized, Double-Blind, Active-Controlled Trial of AXS-05 Administered Orally to Subjects With Major Depressive Disorder

Trial Profile

Randomized, Double-Blind, Active-Controlled Trial of AXS-05 Administered Orally to Subjects With Major Depressive Disorder

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 10 Sep 2019

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At a glance

  • Drugs Bupropion/dextromethorphan (Primary) ; Bupropion
  • Indications Major depressive disorder
  • Focus Adverse reactions; Therapeutic Use
  • Acronyms ASCEND
  • Sponsors Axsome Therapeutics
  • Most Recent Events

    • 21 May 2019 According to an Axsome Therapeutics media release, data from this trial will be presented in oral and poster sessions at the upcoming 2019 American Society For Clinical Psychopharmacology Annual Meeting.
    • 06 May 2019 According to an Axsome Therapeutics media release, ASCEND trial in MDD is now considered sufficient with the ongoing STRIDE-1 Phase 3 trial in TRD, if positive, to support the filing of an NDA (New Drug Application) for approval of AXS-05 for the treatment of MDD.Alternatively, Axsome may file an NDA for AXS-05 for the treatment of MDD with the completed ASCEND trial and a placebo-controlled Phase 3 trial of AXS-05 in MDD.
    • 15 Apr 2019 Status changed from active, no longer recruiting to completed.
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