“A Study of a Deuterated Psilocin Analog (CYB003) in Humans with Major Depressive Disorder” (APPROACH)

This Phase III, placebo-controlled, randomised, quadruple-blind trial (n=220) will assess the efficacy, safety, and tolerability of CYB003, a deuterated psilocin analogue, as an adjunctive treatment for major depressive disorder (MDD). Participants will receive either 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, sponsored by Cybin, aims to evaluate CYB003’s effectiveness in reducing depressive symptoms, measured using the Montgomery-Åsberg Depression Rating Scale (MADRS) and the Beck Depression Inventory-II (BDI-II). The trial will take place across 26 locations in the United States, with an estimated completion date of May 2026. Non-responders in the placebo group will have the option to receive CYB003 in an extension trial.

Topic Depression Safety
Compound Psilocybin Placebo
Country United States of America
Visit trial
Status Recruiting
Results Published No
Start date 15 November 2024
End date 01 May 2026
Phase Phase III
Design Blinded
Type Interventional
Generation Second
Participants 220
Sex All
Age 18- 85
Therapy No

Trial Details

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

Trial Number NCT06564818

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.