Ignite Creation Date:
2024-05-06 @ 9:09 AM
Last Modification Date:
2024-10-26 @ 12:10 PM
Study NCT ID:
NCT02918318
Status:
COMPLETED
Last Update Posted:
2020-10-19
First Post:
2016-09-27
Brief Title:
A Study to Evaluate the Efficacy Safety and Tolerability of Fixed Doses of Intranasal Esketamine in Japanese Participants With Treatment Resistant Depression
Sponsor:
Janssen Pharmaceutical KK
Organization:
Janssen Pharmaceutical KK
Study Overview
Official Title:
A Randomized Double-blind Multicenter Placebo-controlled Study to Evaluate the Efficacy Safety and Tolerability of Fixed Doses of Intranasal Esketamine in Japanese Subjects With Treatment Resistant Depression
Status:
COMPLETED
Status Verified Date:
2020-09
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 study is to evaluate the efficacy of fixed dosed intranasal esketamine compared to intranasal placebo as an add-on to an oral antidepressant in Japanese participants with treatment-resistant depression TRD in improving depressive symptoms
Detailed Description:
None
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 |
|---|---|---|---|
| 54135419TRD2005 | OTHER | Janssen Pharmaceutical KK Japan | None |