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Phase III Long-term Extension Trial to Assess Safety and Efficacy of CYB003 in MDD (EXTEND)

NCT06605105 · Status: ENROLLING_BY_INVITATION · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 468

Last updated 2026-03-11

No results posted yet for this study

Summary

This is a long- term extension of the double-blind trials APPROACH (CYB003-002) and EMBRACE (CYB003-003). Its aim is to examine the safety and long-term efficacy of CYB003 in participants with MDD.

Conditions

Interventions

DRUG

CYB003

CYB003 is a deuterated psilocin analog

Sponsors & Collaborators

  • Worldwide Clinical Trials

    collaborator OTHER

  • Cybin IRL Limited

    lead INDUSTRY

Principal Investigators

  • Clinical Development · Cybin IRL Limited

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2025-07-18
Primary Completion
2028-03-15
Completion
2028-03-15
FDA Drug
Yes

Countries

  • United States

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 NCT06605105 on ClinicalTrials.gov