This is a phase III, international, multi-centre, randomised, parallel group, fixed single-dose, double-blind, placebo-controlled study. The study population will include participants aged ≥18 years with TRD.~Overall, 378 participants will be randomised in a 2:1 ratio to receive COMP360 25 mg or placebo.~The study will last up to 16 weeks including a three- to ten-week Screening Period and six-week follow-up from investigational product (IP) administration.~In this study, the aim is to assess the efficacy of COMP360 25 mg versus placebo for reducing symptom severity in TRD, when administered with psychological support.
Efficacy, Safety, and Tolerability of a single administration of COMP360 in participants with treatment-resistant depression (TRD)