Epigenetic effects on brain function of two new brain-changing drugs: ketamine and MDMA

Competing interests: Conflicts of interest: BY-K received payment for full-time employment from the MAPS or the MAPS Public Benefit Corporation or Lykos Therapeutics throughout her work on the parent trial. JT is the Executive Director of Modern Spirit, a non-profit organization that contributed funds for the MDMA analyses study. BC is on the Board of Directors for Modern Spirit. BC is on the Board of Directors for Modern Spirit. DR is the Executive Director of Board of Medicine, a non-profit organization that contributed funds for the MDMA analyses study. RS and VD are paid employees of TruDiagnostic. Ethics approval and consent to participate: All methods were performed in accordance with the relevant guidelines and regulations. The ketamine study (Dawson et al., 2025) was approved by the Institutional Review Board of the Institute of Regenerative and Cellular Medicine (Approval No. IRCM-2022-320; ClinicalTrials.gov: NCT05294835). The MDMA study (Mitchell et al., 2021) was a multi-site Phase 3 clinical trial (ClinicalTrials.gov: NCT03537014) conducted in accordance with the principles of the Declaration of Helsinki; ethics approval was obtained from the Copernicus Group Independent Review Board, the Western Institutional Review Board, the University of British Columbia Providence Healthcare Research Ethics Board, and the Helsinki Committees of Be’er Ya’akov Ness Ziona Mental Health Center and Chaim Sheba Medical Center. Informed consent was obtained from all participants prior to enrollment in each respective parent trial. No identifiable human images are presented in this manuscript.