EMBRACE Trial

We want to find out whether a new investigational treatment, CYB003, could help people with major depressive disorder (MDD) who are taking a stable dose of antidepressant medication but are not responding well enough to their current treatment.

The EMBRACE study is a Phase III clinical trial looking at whether CYB003, given alongside psychological support, can improve symptoms of depression compared with placebo.

The study is double-blind and randomised. This means that neither you nor the study team will know which treatment you receive. You will have an equal chance of receiving CYB003 8 mg, CYB003 16 mg, or placebo. The study medication is given as an oral capsule at the study clinic.

· You will receive two doses of the study medication, given 3 weeks apart, on Day 1 and Day 22.

· Each dosing visit will last for at least 8 hours and you will be monitored throughout.

· You will receive psychological support before, during and after each dosing session.

· Some study visits can take place remotely by video consultation.

· The study lasts approximately 4 and a half months, including screening, treatment and follow-up.

· There are 19 study visits in total: 9 at the study clinic and 10 remotely.

· The study medication and all study-related tests and procedures are provided at no cost.

· Reasonable travel expenses and meals, where applicable, will be reimbursed.

· You will receive £150 for each dosing visit of at least 8 hours.

· You can stop taking part in the study at any time without giving a reason.

What is CYB003?

CYB003 is an investigational psychedelic medication similar to psilocybin, the active ingredient in Psilocybe mushrooms. It is being studied to see whether, when combined with psychological support, it could help people with major depressive disorder.

CYB003 is not currently an approved treatment for depression. The purpose of this study is to find out whether it is safe, well tolerated and effective.

CYB003 may cause changes in how you experience things. During the dosing session, you may experience changes in your senses, thoughts, emotions or perception of time. Some people may experience changes in mood, confusion, fear, paranoia or feelings of connectedness.

What happens during the study?

Before receiving the study medication, you will have three psychological support sessions. These sessions will help you get to know the Session Monitors, ask questions and prepare for the dosing experience.

On each dosing day, you will receive the study medication at the clinic and remain there for at least 8 hours. Two trained Session Monitors will stay with you throughout the dosing session and provide psychological support. The Study Doctor and study team will also monitor your physical and mental health.

You will then have three further psychological support sessions following each dosing session. These sessions give you an opportunity to discuss and reflect on your experience.

You will need to have someone accompany you home after each dosing session, and you must not drive or operate machinery for at least 24 hours afterwards.

What are the possible side effects?

CYB003 is still being researched, so there may be side effects that are not yet known.

In previous research involving CYB003, reported mild to moderate side effects included:

· Nausea

· Increased blood pressure

· Vomiting

· Headache

· Anxiety

· Increased heart rate

· Dizziness

During the dosing sessions, you may also experience temporary changes in consciousness, perception, thoughts, emotions or your sense of time.

The study team will closely monitor you throughout the dosing session and will only discharge you when the Study Doctor considers it safe for you to leave.

Taking part in the study may or may not improve your depression. Your symptoms could remain the same, improve or become worse.

For more information, please visit the EMBRACE website.

You can also contact Dr Mourad Wahba (PI) or the trial team on psilocybinteam@cntw.nhs.uk.