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NRX101 Glx Biomarker Validation Study | Clinical Trials | Clareo Health

COMPLETEDPHASE2/PHASE3

NRX101 Glx Biomarker Validation Study

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

NCT03402152•NeuroRx, Inc.

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.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•A subject will be eligible for inclusion in this study only if all of the following criteria apply:
•1. 18 to 65 years of age, inclusive, at screening.
•2. Able to understand and provide written and dated informed consent prior to screening. Deemed likely to comply with study protocol and communicate AEs and other clinically important information, and agree to be hospitalized to complete screening and initiate experimental treatment.
•3. Resides in a stable living situation, in the opinion of the investigator
•4. Has an identified reliable informant, in the opinion of the investigator
•5. Diagnosed with bipolar disorder (BD) according to the criteria defined in the DSM-5. The diagnosis of BD will be made by a psychiatrist and supported by the MINI 7.0.2.
•6. Suicidal ideation or behavior as evidenced by an answer of "Yes" to item 2 or item 3 on the C-SSRS.
•7. A score of greater than or equal to 20 on the MADRS.
•8. In good general health, as ascertained by medical history, physical examination (including measurement of seated vital signs), clinical laboratory evaluations, and electrocardiogram
•9. If female, a status of non-childbearing potential or use of an acceptable form of birth control per the following specific criteria:
+8 more criteria

Exclusion Criteria

•A subject will not be eligible for inclusion in this study if any of the following criteria apply:
•1. Female of childbearing potential who is not willing to use one of the specified forms of birth control during the study.
•2. Female who is pregnant or breastfeeding.
•3. Female with a positive pregnancy test at screening or before oral dosing of investigational product.
•4. Current DSM-5 diagnosis of moderate or severe substance use disorder (except marijuana or tobacco use disorder) within the 12 months prior to screening. Substance abuse cannot be the precipitant of entry to treatment.
•5. Subjects with a lifetime history of PCP/ketamine drug use, or failed use of ketamine for depression.
•6. History of schizophrenia or schizoaffective disorder, or any history of psychotic symptoms when not in an acute bipolar mood episode.
•7. History of anorexia nervosa, bulimia nervosa, or eating disorder NOS (OSFED) within five years of screening.
•8. Has dementia, delirium, amnestic, or any other cognitive disorder.
•9. Any major psychiatric disorder, including a personality disorder, which is clinically predominant to BD at screening, or has been the primary focus of treatment predominant to BD at any time within six months prior to screening.
+28 more criteria

Locations (1)

New York State Psychiatric Institute

New York, New York, United States

Key Dates

Start Date

November 1, 2018

Primary Completion Date

January 1, 2021

Completion Date

June 1, 2021

Last Updated

August 9, 2022

Enrollment

ACTUAL participants

Conditions

Bipolar DepressionSuicidal Ideation

Interventions

NRX-101

DRUG

Lurasidone HCl

DRUG

Placebo

DRUG

Accelerated Intermittent Theta Burst Stimulation for Adolescent and Young Adult Depression With Elevated Suicide Risk

NCT07025720

Major Depressive Disorder (MDD)Suicidal Ideation

View study

RECRUITING

University of Iowa Interventional Psychiatry Service Patient Registry

NCT04480918

Treatment Resistant DepressionMajor Depressive Episode+5 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 9, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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NRX101 Glx Biomarker Validation Study

Inclusion Criteria

Exclusion Criteria

Accelerated Intermittent Theta Burst Stimulation for Adolescent and Young Adult Depression With Elevated Suicide Risk

University of Iowa Interventional Psychiatry Service Patient Registry

Efficacy, Tolerability, and Cognitive Effects of Deep Transcranial Magnetic Stimulation for Bipolar Depression

Online Suicide Prevention and Intervention Training for Secondary School Counselors

Augmenting Massed Cognitive Processing Therapy (CPT) to Prevent Suicide Risk Among Patients With PTSD

A Randomized Study of Azetukalner Versus Placebo in Depressive Episodes Associated With Bipolar I or II Disorder (Bipolar Depression)