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Poster 1597275

Improvements in Cognitive and Physical Functioning Outcomes in Depressed Patients Treated with AXS-05 (Dextromethorphan-Bupropion): Results from the EVOLVE Open-Label, Long-Term Study

Shawn Alter, PhD

Psych Congress 2023
This work was sponsored by Axsome Therapeutics Background: Cognitive dysfunction and fatigue contribute significantly to overall impairment in major depressive disorder (MDD). AXS-05 [Auvelity™ (dextromethorphan-bupropion)] is a novel, oral, NMDA receptor antagonist with multimodal activity approved for MDD. We assessed the impact of AXS-05 on cognitive and physical functioning in MDD using the Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (CPFQ). Methods: The EVOLVE trial enrolled 186 US MDD individuals (n=146 directly enrolled), treated with AXS-05 twice daily for up to 15 months. Efficacy endpoints, including MADRS, Sheehan Disability Scale (SDS), and CPFQ were measured at multiple timepoints up to Month 12. Here we present results for directly enrolled patients. Results: AXS-05 treatment significantly improved CPFQ scores from baseline to Weeks 1, 2, and 6 (p

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