Clinical Study of an Investigational Medicine in Adults Aged 18–65 with Depression

About the Study

Treatment-resistant depression (TRD) is a severe form of major depressive disorder (MDD) that does not improve after trying at least two different antidepressant treatments at adequate doses and durations. TRD can have a significant impact on daily functioning, relationships, and overall well-being.

This study is evaluating the safety and effectiveness of an investigational treatment for adults living with TRD. The treatment involves an oral buccal film of the investigational medicine, administered during supervised dosing sessions in a supportive clinical environment. This investigational medicine is being studied for its potential to provide relief from depressive symptoms, enhance emotional well-being, and support recovery.

Who is it for?

You may be eligible if:

• You are aged 18 to 65 years old
• You have treatment-resistant depression
• You are medically and psychologically able to undertake a psychedelic therapy session
• You have not received cancer treatment in the last 2 years
• You are using contraception (if applicable)
• You are willing to commit to a 5-month study

What does study participation look like?

If eligible, participants will be on the study for approximately 5 months. The study includes at least nine in-clinic visits scheduled across screening, baseline, treatment, and follow-up phases.

Appointment duration will vary depending on the visit, ranging from approximately 2–3 hours for screening, baseline, and follow-up visits, to 10 hours or longer for dosing visits to allow for close monitoring by the clinical team.

The study involves two dosing visits during the placebo-controlled period, where participants will be randomly assigned (1:1) to receive either the investigational medicine or placebo. This will be followed by a non-placebo period, in which participants will be re-randomized (1:1) to receive either 60 mg or 120 mg of the investigational medicine in a single dosing visit. This is a blinded study, meaning neither participants nor the study team will know which treatment is being given.

On dosing days, participants will be required to fast for at least two hours before and for at least three hours afterward. All dosing sessions will take place in a professionally supported environment, with trained clinicians providing monitoring and guidance throughout the experience.

In addition to dosing visits, participants will complete psychological assessments and health evaluations, including ECGs, blood and urine tests, and mental health questionnaires. A total of six blood draws will be performed across the study.

There will be a reimbursement for time and travel for eligible participants.