Redefine Study: A Study Evaluating the Efficacy, Safety, and Tolerability of COMP360 in Participants With Post-traumatic Stress Disorder

This Phase II/III, multicentre, randomised, double-blind, controlled trial (n=300) will evaluate the efficacy, safety and tolerability of COMP360 psilocybin in adults with post-traumatic stress disorder (PTSD). The study will compare 25 mg COMP360 with 1 mg COMP360, with 10 mg COMP360 also included, and will assess whether COMP360 can reduce PTSD symptoms when given alongside monitoring and support from a trained study team. Participants are adults aged 18 years and over who have had a PTSD diagnosis for at least 6 months. COMP360 psilocybin will be administered with monitoring and support, and the primary endpoint is the change from baseline to Week 8 in CAPS-5 total severity score for 25 mg versus 1 mg. The trial also includes an open-label extension.