Ignite Creation Date:
2025-12-25 @ 3:24 AM
Ignite Modification Date:
2025-12-26 @ 2:03 AM
Study NCT ID:
NCT06235905
Status:
COMPLETED
Last Update Posted:
2025-10-21
First Post:
2024-01-23
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Open-Label of SPN-820 in Adults With Major Depressive Disorder
Sponsor:
Navitor Pharmaceuticals, Inc.
Organization:
Study Overview
Official Title:
An Open-Label, Single-Group Study to Evaluate the Efficacy and Safety of SPN-820 in Adults With Major Depressive Disorder
Status:
COMPLETED
Status Verified Date:
2025-10
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:
This study will evaluate of the efficacy and safety of SPN-820 in Adults With Major Depressive Disorder (MDD)
Detailed Description:
This is an open-label study of adjunctive SPN-820 (2400 mg) administered orally once every 3 days in adults with 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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| SPN-820 | OTHER | Supernus Pharmaceuticals | View |