NCT02067793.

Study name	Phase 2, randomized, double‐blind, multiple‐dose level, placebo controlled, single intravenous dose, parallel efficacy and safety study of NRX‐1074 in participants with major depressive disorder
Methods	The purpose of this study is to evaluate the efficacy and safety of NRX‐1074 following a single intravenous dose in participants with major depressive disorder
Participants	18 Years to 65 Years Inclusion criteria Male and female participants Aged 18 to 65 years Meets Diagnostic and Statistical Manual, Fourth Edition, Text Revision (DSM‐IV‐TR) criteria for major depressive disorder (MDD) Current episode has lasted ≥ 8 weeks before Screening HRSD‐17 score ≥ 21 before beginning the washout of all current antidepressant agents and/or adjuvant agents HRSD‐17 score ≥ 21 at baseline (after 14 days of washout of current antidepressant agents) Based on both the investigator and Naurex medical monitor's clinical judgment, participants with eating disorders, obsessive compulsive disorder (OCD), panic disorder, post‐traumatic stress disorder (PTSD), and generalised anxiety disorders secondary to major depressive episodes are permitted
Interventions	NRX‐1074 1 mg, 5 mg, 10 mg, placebo
Outcomes	Primary outcome measures: To evaluate the mean change from baseline in HRSD‐17 score for each NRX‐1074 dose group versus the placebo group's mean change. Time frame: Day 1, Day 3, Day 7, Day 14. [Designated as safety issue: No]
Starting date	April 2014
Contact information	Ronald M Burch, MD PhD
Notes	NCT02067793