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NCT06564818 · ClinicalTrials.gov record · last posted 2026-08-12

"A Study of a Deuterated Psilocin Analog (CYB003) in Humans With Major Depressive Disorder"

Name: "A Study of a Deuterated Psilocin Analog (CYB003) in Humans With Major Depressive Disorder" — clinical trial record (NCT06564818)
Creator: DataLookout
License: https://creativecommons.org/licenses/by/4.0/

Study acronym: APPROACH

StatusActive, Not Recruiting

PhasePhase 3

SponsorCybin IRL Limited

Started2024-12-17

View on ClinicalTrials.gov ↗

from the ClinicalTrials.gov record

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.

Protocol amendment history 1 change detected by DataLookout

2026-08-13

Enrollment closed, study ongoing

Trial Details

NCT Number	NCT06564818
Lead Sponsor	Cybin IRL Limited
Conditions	Major Depressive Disorder
Enrollment	220 participants
Start Date	2024-12-17
Primary Completion	2026-08 (estimated)
Study Completion	2026-09 (estimated)
Updated on ClinicalTrials.gov	2026-08-12