A Study of a Psilocybin Analog (CYB003) in Humans With Major Depressive Disorder (APPROACH)

This Phase III randomised, double-blind, placebo-controlled trial (n=220) will study the efficacy, safety, and tolerability of CYB003 (16mg), a synthetic psilocybin analogue, compared to placebo as an adjunctive treatment for major depressive disorder (MDD).

The study, sponsored by Cybin, in collaboration with Worldwide Clinical Trials, is set to begin in November 2024 and conclude in May 2026. Participants aged 18-75 with moderate to severe MDD who have had an inadequate response to antidepressants will receive either 16 mg of CYB003 or placebo in two dosing sessions approximately three weeks apart, whilst continuing their current antidepressant medication. All participants will receive psychological support throughout the trial.

The primary outcome measure is the Montgomery-Åsberg Depression Rating Scale (MADRS), with secondary measures including anxiety, quality of life, and overall clinical impression. The study aims to assess CYB003’s potential as a novel treatment for MDD, particularly for those who have not responded adequately to conventional antidepressants.

Topic Depression
Compound Psilocybin
Country United States of America
Visit trial
Status Not yet recruiting
Results Published No
Start date 01 November 2024
End date 01 May 2026
Phase Phase III
Design Blinded
Type Interventional
Generation Second
Participants 220
Sex All
Age 18- 75
Therapy Yes

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.

NCT 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

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