A Phase 3 Trial to Assess CYB003 (Psilocybin) in Major Depressive Disorder (EMBRACE)
- Study IRB#:2000040270
- Last Updated:07/29/2026
EMBRACE is evaluating an investigational oral study medication, CYB003 (a compound similar to psilocin, the active ingredient in Psilocybe mushrooms), in combination with structured psychological support, while participants continue their existing antidepressant and Therapy Sessions. The goal is to better understand whether this approach may reduce symptoms of MDD. Psychological support is delivered by a licensed therapist trained in EMBARK, with an additional session monitor present during dosing for safety and support.
- Age18 years - 85 years
- GenderBoth
Contact Us
For more information about this study, including how to volunteer, contact:
Daidre Chamberlain
- Phone Number: 1-203-212-9162
Help Us Discover!
You can help our team find trials you might be eligible for by creating a volunteer profile in MyChart. To get started, create a volunteer profile, or contact helpusdiscover@yale.edu, or call +18779788343 for more information.
Eligibility Criteria
Who may be a good fit
Participants may qualify if they:
- Are 18–85 years old
- Have a diagnosis of Major Depressive Disorder (MDD)
- Feel their current antidepressant is not working well enough
- Has to be on at least one antidepressant stable and adequate dose at a consistent dose for at least 4 weeks
- Are able to attend in-person clinic visits and remote sessions as schedule
Key exclusion:
Participants cannot have a psychotic disorder, such as schizophrenia or bipolar disorder.
Additional inclusion/exclusion criteria apply and will be reviewed by the study team during screening.