Trial Profile

An Open-Label Study to Assess the Long-term Safety and Efficacy of AXS-05 in Subjects With Treatment Resistant Depression

Status: Discontinued

Phase of Trial: Phase II

Latest Information Update: 03 Feb 2026

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At a glance

Drugs Bupropion/dextromethorphan (Primary)
Indications Major depressive disorder; Treatment-resistant depressive disorder
Focus Adverse reactions
Acronyms EVOLVE
Sponsors Axsome Therapeutics

Most Recent Events

28 Jan 2026 Actual primary completion date changed from 4 Mar 2022 to 18 Feb 2022.
28 Jan 2026 Status changed to discontinued.
11 Dec 2023 According to an Axsome Therapeutics media release, data from the study were presented at the American College of Neuropsychopharmacology (ACNP) 2023 Annual Meeting, held in Tampa, Florida

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