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NCT06793397 · ClinicalTrials.gov record · last posted 2026-08-26

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

Study acronym: EMBRACE
StatusRecruiting
PhasePhase 3
Started2025-12-10
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from the ClinicalTrials.gov record
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. For more information about the EMBRACE study, including participating study locations, and to register your interest in learning more about participation, please visit the study website: https://embrace-mdd-trial.com/

Amendment record 29 amendments on the ClinicalTrials.gov record

This ClinicalTrials.gov record has been amended 29 times since 2025-01-21; most recent amendment 2026-06-29. DataLookout shows field-level changes from the day a trial enters its daily monitoring; earlier amendments are counted here from the ClinicalTrials.gov version history. See every version on ClinicalTrials.gov ↗

2025-11-20
Status change Not Yet Recruiting→Recruitingv3
Trial Details
NCT Number NCT06793397
Lead Sponsor Cybin IRL Limited
Collaborators: Worldwide Clinical Trials
Conditions Major Depressive Disorder (MDD), Depression in Adults, Depression - Major Depressive Disorder, Depression Disorders, Depression Disorder, Depression
Enrollment 330 participants
Start Date 2025-12-10
Primary Completion 2027-03-18 (estimated)
Study Completion 2027-05-08 (estimated)
Updated on ClinicalTrials.gov 2026-08-26