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

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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: 01 Nov 2024

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At a glance

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

Most Recent Events

  • 29 Oct 2024 According to an Axsome Therapeutics media release, the company presented a Pooled Data from Two Six-Week Controlled Trials (GEMINI and ASCEND) at Psych Congress 2024, being held Oct. 29 - Nov. 2, 2024, in Boston, Massachusetts.
  • 11 Dec 2023 Results of pooled post hoc analysis (from studies GEMINI and ASCEND) presented in the Axsome Therapeutics Media Release
  • 19 Aug 2022 According to an Axsome Therapeutics media release, the U.S. Food and Drug Administration (FDA) has approved AUVELITYTM (dextromethorphan HBr -bupropion HCl) extended-release tablets for the treatment of major depressive disorder (MDD) in adults. Company anticipates AUVELITY to be commercially available in the U.S. in the fourth quarter of 2022.

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