Ignite Creation Date:
2025-12-25 @ 3:09 AM
Ignite Modification Date:
2025-12-31 @ 10:11 PM
Study NCT ID:
NCT06605105
Status:
RECRUITING
Last Update Posted:
2025-11-24
First Post:
2024-09-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase III Long-term Extension Trial to Assess Safety and Efficacy of CYB003 in MDD (EXTEND)
Sponsor:
Cybin IRL Limited
Organization:
Study Overview
Official Title:
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:
RECRUITING
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EXTEND
Brief 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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: