An Open Label Study of the Safety and Efficacy of Psilocybin in Participants With Treatment-Resistant Depression (P-TRD)

Open-label single-group Phase II trial administering 25 mg oral psilocybin (COMP360) to adults with treatment-resistant depression under supportive therapeutic conditions; primary purpose is treatment.

Actual enrolment reported as 27. CA site includes a re-dosing option for participants with symptom exacerbation at least 12 months after initial dosing; outcomes include depressive symptom change and safety/tolerability measures.