Ignite Creation Date:
2024-05-06 @ 2:57 PM
Last Modification Date:
2024-10-26 @ 1:40 PM
Study NCT ID:
NCT04476446
Status:
COMPLETED
Last Update Posted:
2023-09-14
First Post:
2020-07-15
Brief Title:
An Expanded Access Protocol for Esketamine Treatment in Participants With Treatment Resistant Depression TRD Who do Not Have Other Treatment Alternatives
Sponsor:
Janssen-Cilag SA
Organization:
Janssen-Cilag SA
Study Overview
Official Title:
An Open-Label Expanded Access Protocol for Esketamine Treatment of Subjects With Treatment Resistant Depression TRD Who do Not Have Other Treatment Alternatives
Status:
COMPLETED
Status Verified Date:
2023-09
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:
The purpose of this expanded access program EAP is to provide expanded access to esketamine treatment and collect additional safety data and quality of life until esketamine is commercially available for participants with Treatment-Resistant Depression TRD
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 54135419TRD4006 | OTHER | Janssen-Cilag SA | None |