Ignite Creation Date:
2024-05-06 @ 3:56 AM
Last Modification Date:
2024-10-26 @ 11:41 AM
Study NCT ID:
NCT02418585
Status:
COMPLETED
Last Update Posted:
2020-06-02
First Post:
2015-04-13
Brief Title:
A Study to Evaluate the Efficacy 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 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:
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:
TRANSFORM-2
Brief Summary:
The purpose of this study is to compare the efficacy and safety of switching treatment-resistant depression TRD subjects from a prior antidepressant treatment to which they have not responded to either intranasal esketamine plus a new oral antidepressant or switching to a new oral antidepressant plus intranasal placebo
Detailed Description:
This is a randomized double-blind neither the researchers nor the subjects know what treatment the subject is receiving active-controlled multicenter study more than 1 study site in subjects with TRD to assess the efficacy safety and tolerability of flexible doses of intranasal esketamine plus a newly initiated oral antidepressant compared with a newly initiated oral antidepressant active comparator plus intranasal placebo The study will consist of 3 phases ScreeningProspective Observational Phase 4-7 weeks Double-blind Induction Phase 4-weeks Follow-up Phase 24-weeks Subjects who rollover into a long-term maintenance study will not participate in the Follow-up Phase The antidepressant treatment as well as any other ongoing medications being taken for depression at screening including adjunctive augmentation therapies will continue unchanged at the same dosage from the start of Week 1 through the end of Week 4 of the screeningprospective observational phase Subjects 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 |
|---|---|---|---|
| 2014-004585-22 | EUDRACT_NUMBER | Janssen Research Development LLC | None |
| ESKETINTRD3002 | OTHER | None | None |