Ignite Creation Date:
2024-05-06 @ 11:05 AM
Last Modification Date:
2024-10-26 @ 12:40 PM
Study NCT ID:
NCT03434041
Status:
COMPLETED
Last Update Posted:
2024-04-26
First Post:
2018-02-09
Brief Title:
A Study to Evaluate the Efficacy Pharmacokinetics Safety and Tolerability of Flexible Doses of Intranasal Esketamine Plus an Oral Antidepressant 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 to Evaluate the Efficacy Pharmacokinetics Safety and Tolerability of Flexible Doses of Intranasal Esketamine Plus an Oral Antidepressant in Adult Subjects With Treatment-resistant Depression
Status:
COMPLETED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
True
If Expanded Access, NCT#:
NCT03829579
Has Expanded Access, NCT# Status:
APPROVED_FOR_MARKETING
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate the efficacy of switching adult participants with treatment-resistant depression TRD from a prior antidepressant treatment to which they have not responded to flexibly dosed intranasal esketamine 56 milligram mg or 84 mg plus a newly initiated oral antidepressant compared with switching to a newly initiated oral antidepressant active comparator plus intranasal placebo in improving depressive symptoms Efficacy will be assessed by the change from baseline in the Montgomery Asberg Depression Rating Scale MADRS total score from Day 1 before randomization to the end of the 4-week double-blind treatment phase
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ESKETINTRD3006 | OTHER | Janssen Research Development LLC | None |