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

NCT06793397 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 330

Last updated 2026-08-17

No results posted yet for this study

Summary

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/

Conditions

  • Major Depressive Disorder (MDD)
  • Depression in Adults
  • Depression - Major Depressive Disorder
  • Depression Disorders
  • Depression Disorder
  • Depression

Interventions

DRUG

CYB003

CYB003 is a deuterated psilocin analog.

BEHAVIORAL

Psychological Support

Manualized psychological support performed by facilitator.

Sponsors & Collaborators

  • Worldwide Clinical Trials

    collaborator OTHER

  • Cybin IRL Limited

    lead INDUSTRY

Principal Investigators

  • Felix Mazer · Cybin IRL Limited

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-10
Primary Completion
2027-03-18
Completion
2027-05-08
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Czechia
  • Germany
  • Greece
  • Ireland
  • Poland
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06793397 on ClinicalTrials.gov