Ketamine molecule:

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Ketamine Clinical Trials

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

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Id: NCT03402152

Organisation Name: NeuroRx, Inc.

Overal Status: Active, not recruiting

Start Date: November 1, 2018

Last Update: September 8, 2021

Lead Sponsor: NeuroRx, Inc.

Brief 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.

  • Bipolar Depression
  • Suicidal Ideation

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