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

NCT06564818 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 220

Last updated 2026-05-06

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

CYB003

CYB003 is a Deuterated Psilocin Analog.

BEHAVIORAL

Psychological Support

Manualized psychological support performed by facilitators

DRUG

Placebo

Placebo

Sponsors & Collaborators

  • Cybin IRL Limited

    lead INDUSTRY

Principal Investigators

  • Clinical Development · 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
2024-12-17
Primary Completion
2026-08-31
Completion
2026-09-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
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 NCT06564818 on ClinicalTrials.gov