Ignite Creation Date:
2024-05-06 @ 7:14 AM
Last Modification Date:
2024-10-26 @ 11:46 AM
Study NCT ID:
NCT02493868
Status:
COMPLETED
Last Update Posted:
2020-06-02
First Post:
2015-05-13
Brief Title:
A Study of Intranasal Esketamine Plus an Oral Antidepressant for Relapse Prevention in Adult Participants With Treatment-resistant Depression
Sponsor:
Janssen Research Development LLC
Organization:
Janssen Research Development LLC
Study Overview
Official Title:
A Randomized Double-blind Multicenter Active-Controlled Study of Intranasal Esketamine Plus an Oral Antidepressant for Relapse Prevention in Treatment-resistant Depression
Status:
COMPLETED
Status Verified Date:
2020-05
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-1
Brief Summary:
The purpose of this study is to assess the efficacy of intranasal esketamine plus an oral antidepressant compared with an oral antidepressant active comparator plus intranasal placebo in delaying relapse of depressive symptoms in participants with treatment-resistant depression TRD who are in stable remission after an induction and optimization course of intranasal esketamine plus an oral antidepressant
Detailed Description:
This is a randomized double-blind neither the researchers nor the participant know what treatment the participants is receiving active-controlled multicenter more than 1 study site study in participants with TRD to assess the efficacy of intranasal esketamine plus an oral antidepressant compared with an oral antidepressant active comparator plus intranasal placebo in delaying relapse of depressive symptoms The study will consist of 5 phases ScreeningProspective Observational Phase 4-7weeks for direct-entry participants only Open-label Induction Phase 4-weeks for direct-entry participants only Optimization Phase 12-weeks open-label for direct-entry participants and double-blind for transferred-entry participants Maintenance Phase variable duration double-blind for all participants and Follow-up Phase 2-weeks 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 |
|---|---|---|---|
| 2014-004586-24 | EUDRACT_NUMBER | Janssen Research Development LLC | None |
| ESKETINTRD3003 | OTHER | None | None |