NCT03402152

NRX101 Glx Biomarker Validation Study

Validation of the Glx Biomarker for Treatment of Moderate Bipolar Depression With NRX-101

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: NeuroRx, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Subnormal level of Glutamate+Glutamine (Glx) in the Anterior Cingulate Cortex (ACC) of the brain has been associated with depression and PTSD. Similarly, interventions that increase the level of Glx in the brain, specifically electroconvulsive therapy (ECT) and intravenous ketamine infusion have been associated with a rapid decrease in depression and suicidal ideation. This effect has been demonstrated in a dose-dependent manner in randomized clinical assessments. D-cycloserine, a glycine site modulator of NMDA receptor function has been demonstrated to increase Glx in the ACC of normal volunteers. The purpose of this study is to determine whether NRX-101, an experimental drug containing a fixed dose combination of D-cycloserine and lurasidone (1) raises Glx by a greater amount than either placebo or lurasidone alone in patients with bipolar depression, and (2) whether that elevation in Glx is correlated with a decrease in depression.

Conditions

• Bipolar Depression
• Suicidal Ideation

Interventions

Type	Name	Description
DRUG	NRX-101	NRX-101, a fixed dose combination of D-cycloserine+lurasidone will be given twice a day by mouth
DRUG	Lurasidone HCl	Lurasidone HCl will be given twice a day by mouth
DRUG	Placebo	Placebo oral capsule

Timeline

• Start date: 2018-11-01
• Primary completion: 2021-01-01
• Completion: 2021-06-01
• First posted: 2018-01-18
• Last updated: 2022-08-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study