Ignite Creation Date:
2024-05-06 @ 12:42 PM
Last Modification Date:
2024-10-26 @ 1:03 PM
Study NCT ID:
NCT03829579
Status:
APPROVED_FOR_MARKETING
Last Update Posted:
2020-02-10
First Post:
2019-02-01
Brief Title:
Pre-Approval Access to Esketamine Nasal Spray for the Treatment of Treatment-Resistant Depression TRD
Sponsor:
Janssen Research Development LLC
Organization:
Janssen Research Development LLC
Study Overview
Official Title:
Esketamine Single Patient Request
Status:
APPROVED_FOR_MARKETING
Status Verified Date:
2020-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a pre-approval access program PAAP for eligible participants The main purpose of this program is to provide access to esketamine nasal spray to eligible participant with treatment-resistant depression TRD who have exhausted all other treatment options including all alternative treatment options with marketed therapies
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
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 |
|---|---|---|---|
| 54135419TRD3012 | OTHER | Janssen Research Development LLC | None |