Efficacy, Safety, and Tolerability of COMP360 in Participants With TRD (COMP005)

This international, multi-centre, randomised (2:1), parallel-group, double-blind study evaluates the efficacy and safety of a single 25 mg COMP360 psilocybin dose versus matched placebo in adults with treatment-resistant depression. Part A comprises a 6‑week follow-up after the single administration; Parts B and C assess re-treatment durability and open‑label treatment respectively.

Primary outcome is reduction in depressive symptom severity (MADRS) at 6 weeks. Safety assessments include adverse events, vital signs, and standard clinical labs; psychological support is provided around dosing sessions.