Ignite Creation Date:
2025-12-25 @ 1:05 AM
Ignite Modification Date:
2026-02-28 @ 8:19 AM
Study NCT ID:
NCT02067793
Status:
COMPLETED
Last Update Posted:
2016-03-17
First Post:
2014-02-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Intravenous NRX-1074 in Patients With Major Depressive Disorder
Sponsor:
Naurex, Inc, an affiliate of Allergan plc
Organization:
Study Overview
Official Title:
Phase 2, Randomized, Double-Blind, Multiple-Dose Level, Placebo Controlled, Single Intravenous Dose, Parallel Efficacy and Safety Study of NRX-1074 in Subjects With Major Depressive Disorder
Status:
COMPLETED
Status Verified Date:
2016-02
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 and safety of NRX-1074 following a single intravenous dose in subjects with major depressive disorder.
Detailed Description:
NRX-1074 is a N-methyl-D-aspartate (NMDA) receptor functional partial agonist with efficacy in animal models of affective disorders including major depressive disorder. The purpose of this study is to evaluate efficacy and safety of NRX-1074 at dose levels that are predicted by comparison of human and animal pharmacokinetics to be efficacious.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: