Phase III randomised, double-blind, placebo-controlled trial (n=255) comparing a single 25 mg COMP360 psilocybin dose plus psychological support versus placebo in adults with treatment-resistant depression (Part A).
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.
Single fixed 25 mg COMP360 (psilocybin) dose administered with psychological support (Part A).
COMP360 formulation administered under supportive conditions
Matched placebo with psychological support.
Matched placebo comparator