Efficacy, Safety, and Tolerability of COMP360 in Participants With TRD

Study Overview: This study tests a new drug called COMP360 for people with treatment-resistant depression (TRD). TRD means that regular depression medicines haven't worked. The study will last about 62 weeks, which is more than a year. It's happening in different countries.

Study Design: This is a double-blind study, meaning neither the doctors nor the participants know who gets the real medicine or a placebo (a fake treatment). There are 255 people participating, and they will be divided into groups, with some getting COMP360 and others getting the placebo. The study has three parts: A, B, and C. Part A lasts 6 weeks and tests one dose of COMP360. Part B checks how well the treatment lasts and its safety for 20 weeks. Part C allows for open-label treatment for 26 weeks, meaning everyone will know they're getting the real medicine.

• The study lasts for 62 weeks, with three parts.
• Participants need to be at least 18 years old.
• The study includes psychological support along with medication.