The study, delivered at the NIHR Clinical Research Facility (CRF): Oxford Health, is part of Compass Pathways’ international Phase 3 programme. This programme evaluates COMP360 psilocybin, administered alongside psychological support, for individuals with treatment-resistant depression (TRD), defined as depression that has not responded adequately to at least two antidepressant treatments.
Since opening in Oxford in 2024, the research team has supported participants through treatment sessions, follow-up assessments, and long-term monitoring. While final analysis is ongoing, Compass Pathways reported in February 2026 a statistically significant reduction in depression symptom severity at six weeks for participants receiving two doses of COMP360 25mg compared to the 1mg comparator group. Discussions with the US Food and Drug Administration (FDA) are also confirmed as part of their regulatory submission process.
The completion of the final participant’s visit signifies the end of Oxford’s active delivery phase and the commencement of the next stage of analysis across the international programme. Researchers will continue to analyse longer-term data, with future regulatory decisions pending review of the full evidence by relevant authorities.
Dr Katharine Smith, Consultant Psychiatrist at Oxford Health NHS Foundation Trust and Principal Investigator for COMP006 at Oxford, stated, “Reaching the final participant visit is an important milestone for everyone involved in this study. We are incredibly grateful to the participants who gave their time and commitment to this research, as well as the dedicated study team who supported them throughout. While further analyses are still ongoing, this marks the completion of a significant phase of work and brings us closer to understanding the potential role this investigational treatment may have for people living with treatment-resistant depression.”
The CRF: Oxford Health, building on its expertise in novel treatments for depression, is planning further studies in a variety of novel treatments, including psychedelic treatments, for different mental health conditions.
