NCT02067793

Study of Intravenous NRX-1074 in Patients With Major Depressive Disorder

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 151 (actual)
• Sponsor: Naurex, Inc, an affiliate of Allergan plc · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Major Depressive Disorder

Interventions

Type	Name	Description
DRUG	NRX-1074 1 mg	Single intravenous administration of 1 mg into arm on Day 0
DRUG	Placebo	Single intravenous injection into the arm on Day 0
DRUG	NRX-1074 5 mg	Single intravenous injection of 5 mg into the arm on Day 0
DRUG	NRX-1074 10 mg	Single intravenous injection of 10 mg into the arm on Day 0

Timeline

• Start date: 2014-03-01
• Primary completion: 2015-02-01
• Completion: 2015-02-01
• First posted: 2014-02-20
• Last updated: 2016-03-17

Locations

12 sites across 1 country: United States