A Phase 3 Trial to Assess CYB003 in Major Depressive Disorder (EMBRACE)

This Phase III, double-blind, randomised controlled trial (n=330) will assess the efficacy, safety, and tolerability of a synthetic psilocybin analogue (CYB003) as an adjunctive treatment for major depressive disorder (MDD). Participants will receive either 8 mg or 16 mg of CYB003, or a placebo, in two dosing sessions approximately three weeks apart, while continuing their current antidepressant medication and receiving psychological support.

The study is sponsored by Cybin and is expected to run from July 2025 to May 2027. It will measure changes in depressive symptoms using the Montgomery-Åsberg Depression Rating Scale (MADRS) and secondary outcomes such as anxiety levels, quality of life, and overall clinical improvement. Participants must be aged 18–85, diagnosed with moderate-to-severe MDD, and on a stable dose of antidepressants. Those with treatment-resistant depression, psychotic disorders, or significant suicide risk will be excluded.

Topic Depression Anxiety
Compound Psilocybin
Country Canada United States of America
Visit trial
Status Planned
Results Published No
Start date 08 July 2025
End date 08 May 2027
Phase Phase III
Design Blinded
Type Interventional
Generation Second
Participants 330
Sex All
Age 18- 85
Therapy No

Trial Details

The purpose of this study is to determine the efficacy, safety and tolerability of CYB003 compared to matching placebo as adjunctive treatment in patients with MDD.

Trial Number NCT06793397

Sponsors & Collaborators

Cybin
Cybin is a for-profit company that aims to deliver psychedelics (psilocybin) via a sublingual delivery mechanism. The company aims to start clinical trials within the year (2021). It has raised $98 million US.

Data attribution

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