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

To be considered for this study, you need to be at least 18 years old. You must have major depression, and your depression shouldn't involve any symptoms of psychosis (like hallucinations or delusions). Specifically, your depression must be considered "treatment resistant," meaning you've tried and not responded well to at least two to four different antidepressant medications for your current episode of depression.

There are also some reasons why you wouldn't be able to join. For example, if you have ever been diagnosed with bipolar disorder, schizophrenia, or certain other serious mental health conditions like ongoing PTSD or severe eating disorders, you wouldn't be eligible. Also, if you've been in hospital for a psychiatric reason in the last year, or have received treatments like electroconvulsive therapy (ECT) recently for your current depression episode, you wouldn't be able to take part.

If you decide to join this study, your journey will be split into three main parts, lasting about 62 weeks in total. First, there's a screening period of three to ten weeks where doctors will check if the study is right for you. If you qualify, you'll be assigned to one of three groups to receive two administrations of COMP360 (at 25mg, 10mg, or 1mg) along with psychological support.

After receiving the first study treatment, you'll have check-ups and follow-ups. Part A involves a nine-week follow-up. Part B extends this follow-up to 26 weeks from your first treatment. Finally, Part C will follow your progress for a full 52 weeks after your initial treatment. Throughout this time, you will have regular visits with the study team for assessments, which will help them understand how you are responding to the treatment and to monitor your well-being.