A Phase II, Multicentre, Randomised, Double-blind, Controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Efficacy of COMP360 in Participants With Major Depressive Disorder With One Prior Treatment Failure

Multi-centre, randomised, double-blind, parallel-group Phase II study comparing single oral doses of COMP360 (25 mg, 10 mg, 1 mg) in adults with major depressive disorder administered with psychological support.

Primary aims are safety and tolerability; secondary assessments include pharmacokinetics and efficacy measures (MADRS) with follow-up to six weeks post‑dosing.

The study randomises 102 participants 1:1:1 and follows participants for up to 16 weeks including screening and a six‑week follow‑up.