Introducing the EMBRACE clinical trial

The EMBRACE trial is exploring an investigational psychedelic substance, combined with psychological support while you stay on your current antidepressant, to learn how effective it might be at reducing symptoms of Major Depressive Disorder (MDD).

In recent years there has been growing interest in the potential role psychedelic substances could play in the treatment of mental health conditions.

The investigational study medicine, called CYB003, is similar to psilocin (the active ingredient in Psilocybe mushrooms). Psychedelic substances, at certain doses, may cause an altered state of consciousness, unique thoughts, and changes in your senses, such as hearing, seeing, tasting, and/or smelling things that are not real. The purpose of the study is to investigate whether psychological support and CYB003 given together may help people who don’t feel content with their current antidepressant medication, to reach deeper into their thoughts, promote healing, and may be effective in treating MDD.

A licensed therapist with training in EMBARK, a psychological support model for MDD, will work with study participants during several psychological support sessions before and after the dosing sessions. They, along with a second session monitor, will also attend the dosing sessions for both psychological support and safety purposes.

EMBRACE is a “Phase 3 clinical trial”, which means the investigational study medicine has already been given to healthy volunteers and MDD patients in previous “Phase 1 & 2 clinical trials” to check for risks and see what doses may be appropriate. Phase 3 trials include more patients and are designed to test whether the investigational study medicine may be effective.