Ignite Creation Date:
2025-12-24 @ 11:30 PM
Ignite Modification Date:
2026-07-09 @ 7:43 AM
Study NCT ID:
NCT03614156
Status:
TERMINATED
Last Update Posted:
2020-10-09
First Post:
2018-07-30
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of Monotherapy Rapastinel in the Prevention of Relapse in Patients With Major Depressive Disorder (MDD)
Sponsor:
Naurex, Inc, an affiliate of Allergan plc
Organization:
Study Overview
Official Title:
A Randomized, Double-blind, Placebo-controlled, Multi-center Study of Rapastinel in the Prevention of Relapse in Patients With Major Depressive Disorder
Status:
TERMINATED
Status Verified Date:
2020-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Business decision to stop the program.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study will evaluate the efficacy, safety, and tolerability of 450 milligrams (mg) or 225 mg of Rapastinel compared to placebo in the prevention of relapse in participants with major depressive disorder (MDD).
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2018-000064-28 | EUDRACT_NUMBER | None | View |