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NCT06605105 · ClinicalTrials.gov record · last posted 2026-07-13

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

Study acronym: EXTEND
StatusEnrolling by Invitation
PhasePhase 3
Started2025-07-18
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from the ClinicalTrials.gov record
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.

Protocol amendment history 1 change detected by DataLookout

2026-07-14
Trial sites expanded: 19 → 33 locations
Trial Details
NCT Number NCT06605105
Lead Sponsor Cybin IRL Limited
Collaborators: Worldwide Clinical Trials
Conditions Major Depressive Disorder
Enrollment 468 participants
Start Date 2025-07-18
Primary Completion 2028-03-15 (estimated)
Study Completion 2028-03-15 (estimated)
Updated on ClinicalTrials.gov 2026-07-13