The Safety and Efficacy of Psilocybin as an Adjunctive Therapy in Participants with Treatment-Resistant Depression

Open-label single-group Phase II study administering a single 25 mg dose of COMP360 psilocybin to adults with treatment-resistant depression while maintained on a single SSRI, with psychological support.

N=19 actual; rapid significant decreases in depressive symptoms were observed with over 40% of participants sustaining response at 3 months. Outcomes included HDRS-17 changes and safety/tolerability assessments.