Ignite Creation Date:
2025-12-24 @ 7:36 PM
Ignite Modification Date:
2025-12-25 @ 11:45 PM
Study NCT ID:
NCT05439603
Status:
COMPLETED
Last Update Posted:
2024-12-31
First Post:
2022-06-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
ANC-501 in the Treatment of Adults With Major Depressive Disorder
Sponsor:
Ancora Bio, Inc. d/b/a EmbarkNeuro, Inc.
Organization:
Study Overview
Official Title:
A Phase 2 Study of ANC-501 in the Treatment of Adults With Major Depressive Disorder
Status:
COMPLETED
Status Verified Date:
2023-02
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:
None
Brief Summary:
A Phase 2 Study of ANC-501 in the treatment of adults with Major Depressive Disorder
Detailed Description:
This is a single-arm, open-label Phase 2 study to assess the safety, tolerability, pharmacokinetics (PK), and activity of ANC-501 oral capsules as adjunctive treatment in subjects diagnosed with major depressive disorder (MDD)
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?: