Ignite Creation Date:
2024-05-06 @ 3:19 PM
Last Modification Date:
2024-10-26 @ 1:47 PM
Study NCT ID:
NCT04599855
Status:
COMPLETED
Last Update Posted:
2024-03-12
First Post:
2020-10-21
Brief Title:
A Study of Esketamine Nasal Spray Administered as Monotherapy 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 Placebo-controlled Study to Evaluate the Efficacy Safety and Tolerability of Esketamine Nasal Spray Administered as Monotherapy in Adult Participants With Treatment-resistant Depression
Status:
COMPLETED
Status Verified Date:
2024-03
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 each individual dose of esketamine nasal spray 56 milligram mg and 84 mg compared with placebo nasal spray in improving depressive symptoms in participants with treatment resistant depression TRD as assessed by the change from baseline in the Montgomery-Asberg Depression Rating Scale MADRS total score from Day 1 prerandomization to the end of the 4 week double-blind treatment phase Day 28
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 |
|---|---|---|---|
| 54135419TRD4005 | OTHER | Janssen Research Development LLC | None |