CYB001 to evaluate as a potential treatment for Major Depressive Disorder

Cybin has received approval from the Institutional Review Board (IRB) at the University of the West Indies Hospital in Jamaica for a Phase II trial of its psilocybin formulation, CYB001, to treat major depressive disorder (MDD).

This Phase II trial will assess Cybin’s sublingual psilocybin formulation versus a 25mg psilocybin capsule. A Phase IIa study will enrol 40 patients to determine the bio-equivalent dose of CYB001 when compared to a 25mg capsule.

Topic Depression
Country Jamaica
Visit trial
Status Planned
Results Published
Start date 01 December 2021
End date 01 June 2023
Phase Phase II
Design Open
Type Interventional
Generation Second
Participants 50
Sex All
Age 18- 99
Therapy No

Trial Details

This Phase II trial will assess Cybin’s sublingual psilocybin formulation versus a 25mg psilocybin capsule. A Phase IIa study will enrol 40 patients to determine the bio-equivalent dose of CYB001 when compared to a 25mg capsule.

Trial Number

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

A large set of the trials in our database are sourced from ClinicalTrials.gov (CTG). We have modified these post to display the information in a more clear format or to correct spelling mistakes. Our database in actively updated and may show a different status (e.g. completed) if we have knowledge of this update (e.g. a published paper on the study) which isn't reflected yet on CTG. If a trial is not sourced from CTG, this is indicated on this page and you can follow the link to the alternative source of information.