Efficacy, Safety, and Tolerability of Two Administrations of COMP360 in Participants With TRD (COMP 006)

International, multi-centre, randomised (2:1:1), parallel-group, double-blind (quadruple-masked) Phase III study assessing efficacy and safety of two administrations of COMP360 (psilocybin) in adults with treatment-resistant depression.

Total planned duration approximately 62 weeks including screening; study includes three parts with follow-up out to 9 weeks (Part A), 26 weeks (Part B) and 52 weeks (Part C) from initial investigational product administration. Psychological support is provided alongside dosing.