Trials / Enrolling By Invitation
Enrolling By InvitationNCT06605105
Phase III Long-term Extension Trial to Assess Safety and Efficacy of CYB003 in MDD (EXTEND)
A Phase III Long-Term Extension Trial With Optional Additional Doses of CYB003 to Assess the Safety and Long-term Efficacy in Participants With Major Depressive Disorder (EXTEND)
- Status
- Enrolling By Invitation
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 468 (estimated)
- Sponsor
- Cybin IRL Limited · Industry
- Sex
- All
- Age
- 18 Years – 85 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| DRUG | CYB003 | CYB003 is a deuterated psilocin analog |
Timeline
- Start date
- 2025-07-18
- Primary completion
- 2028-03-15
- Completion
- 2028-03-15
- First posted
- 2024-09-20
- Last updated
- 2026-03-11
Locations
19 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06605105. Inclusion in this directory is not an endorsement.