Ignite Creation Date:
2024-05-06 @ 8:39 AM
Last Modification Date:
2024-10-26 @ 12:02 PM
Study NCT ID:
NCT02782104
Status:
COMPLETED
Last Update Posted:
2024-02-20
First Post:
2016-04-29
Brief Title:
A Long-term Safety Study of Esketamine Nasal Spray in Treatment-resistant Depression
Sponsor:
Janssen Research Development LLC
Organization:
Janssen Research Development LLC
Study Overview
Official Title:
An Open-label Long-term Extension Safety Study of Esketamine Nasal Spray in Treatment-resistant Depression
Status:
COMPLETED
Status Verified Date:
2024-02
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:
SUSTAIN-3
Brief Summary:
The purpose of this study is to assess the safety and tolerability of esketamine nasal spray in participants with treatment-resistant depression TRD
Detailed Description:
This is an open-label the researchers and participants know the treatment the participant is receiving long-term extension study The study will consist of 2 open-label Phases 4-week Induction phase if applicable and Open-Label OptimizationMaintenance phase variable Participants will enter the study Induction Phase from ESKETINTRD3001 NCT02417064 ESKETINTRD3002 NCT02418585 ESKETINTRD3003 NCT02493868 ESKETINTRD3005 NCT02422186 and ESKETINTRD3006 US sites only Participants will enter the study Open-Label OptimizationMaintenance phase from ESKETINTRD3001 NCT02417064 ESKETINTRD3002 NCT02418585 ESKETINTRD3003 NCT02493868 if appropriate at week 16 or ESKETINTRD3006 US sites only In the Open-Label Induction Phase participants will self-administer flexibly-dosed esketamine nasal spray During first 4 weeks in OptimizationMaintenance Phase responder participants from the induction phase of study 54135419TRD3008 will continue on the same dose of esketamine nasal spray from the induction phase and have a weekly intranasal treatment session frequency Participants entering the optimizationmaintenance phase from study ESKETINTRD3005 will also have a weekly intranasal treatment session frequency However as the ESKETINTRD3005 intranasal study medication is blinded at the time of entry into the current study the dose of esketamine nasal spray will be administered as outlined in protocol Participants entering the optimizationmaintenance phase from study ESKETINTRD3003 Direct Entry or ESKETINTRD3004 who were ongoing in the Optimization Maintenance or OptimizationMaintenance phase respectively will have the option to have their current intranasal dosing frequency adjusted at the time of entry into 54135419TRD3008 study and should remain on the selected frequency from week 1 to week 4 A one-time dose change will be permitted at study entry After 4 weeks esketamine nasal spray treatment sessions will be individualized to either once weekly or once every other week at the fixed 2-week interval based on clinical global impression - severity CGI-S performed at that visit and every 4 weeks for participants dosed at the 4 week interval Participants safety will be monitored throughout the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
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 |
|---|---|---|---|
| 54135419TRD3008 | OTHER | None | None |
| 2015-003578-34 | EUDRACT_NUMBER | Janssen Research Development LLC | None |