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| Name | Class |
|---|---|
| Prevail Infoworks | INDUSTRY |
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NMDA antagonist drugs have shown to reduce symptoms of depression and suicidal ideation. NeuroRx has developed NRX-101 (fixed dose combination of D-cycloserine and lurasidone) for oral use in the treatment of bipolar depression with suicidal ideation. This study will test the hypothesis that NRX-101 is superior to lurasidone alone (standard of care) in maintaining remission from symptoms of depression (primary endpoint) and suicidal ideation or behavior (declared secondary endpoint) over a six week period of twice-daily oral dosing.
Background and Rationale: NMDA antagonist drugs have shown to reduce symptoms of depression and suicidal ideation. NRX-101 is composed of D-cycloserine (DCS) an NMDA antagonist and lurasidone (5HT2a atypical antipsychotic and antidepressant). In a phase 2 clinical study of bipolar depression and acute suicidal ideation and behavior, (in patients requiring hospitalization) patients received an initial infusion of ketamine and then NRX-101 for 6 weeks. In that phase 2 study, NRX-101 showed the ability to maintain remission from depression and suicidality over 6 weeks when taken twice daily. In this current out patient study, patients with bipolar depression and subacute suicidality (not requiring hospitalization), ketamine will not be used.
Primary Objective:
Secondary Objectives:
• To test the hypothesis that treatment with NRX-101 is superior to standard of care (lurasidone) in reducing suicidality in depressed bipolar patients with SSIB, as measured by the Columbia Suicide Severity Rating Scale (C-SSRS)
Methodology: : A multi-center, randomized, double-blind, trial in which patients with bipolar depression (MADRS ≥30) and subacute levels of suicidal ideation (C-SSRS 3 or 4, not requiring hospitalization) are randomized to receive twice daily oral NRX-101 or lurasidone (standard of care).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NRX-101 | Experimental | Following study enrollment and randomization, subjects will receive twice daily NRX-101 |
|
| Lurasidone | Active Comparator | Following study enrollment, subjects will receive twice daily lurasidone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NRX-101 | Drug | NRX-101, a fixed dose combination of D-cycloserine+lurasidone will be given twice a day by mouth |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in MADRS-10 over 42 Days | Mean change from baseline to endpoint (Day 42/exit) in total MADRS score, a 10-item clinician-rated scale, with each item rated on a 0-6 severity scale (0 Minimum, 60 maximum), where higher scores indicate a worse outcome | Six weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change from baseline in CGI-SS | Mean change from baseline to exit (Day 42/exit) in CGI-SS score | Six Weeks |
| Time to Treatment Failure | Time to relapse, where relapse is defined as experiencing a return of suicidality in the Columbia Suicide Severity Rating Scale (C-SSRS) of >=4)), or a return to baseline levels of depression following an improvement of 25% or greater on the MADRS score, or the need to implement a new treatment plan. The C-SSRS is a low-burden measure of the spectrum of suicidal ideation and behavior that was developed in the National Institute of Mental Health Treatment of Adolescent Suicide Attempters Study to assess severity and track suicidal events through any treatment. A lower score on the C-SSRS indicates a better outcome (min=0, max=5) |
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Inclusion Criteria:
Exclusion Criteria:
Subject has current DSM-5 diagnosis of moderate or severe substance use disorder (except marijuana or tobacco use disorder) within the 12 months prior to Screening.
Subject has a lifetime history of:
Subject has schizophrenia or schizoaffective disorder, or any history of psychotic symptoms when not in an acute bipolar mood episode.
Subject has a current major psychiatric disorder, diagnosed at Screening
Subject has been prescribed more than one agent in each of the following categories at randomization:
Subject has signs and symptoms of active or residual COVID-19, or unresolved symptoms of COVID-19 that impact health
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| Name | Affiliation | Role |
|---|---|---|
| Martin Brecher, MD | NRx Pharma | Study Director |
| Andrew A Nierenberg, MD | Harvard Medical School (HMS and HSDM) | Study Chair |
| Jonathan C Javitt, MD, MPH | NRx Pharmaceuticals | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Science 37 | Culver City | California | 90320 | United States | ||
| San Marcus Research Clinic, Inc. |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39714786 | Derived | Sapko MT, Kolesar C, Sharp IR, Javitt JC. Quality Assurance of Depression Ratings in Psychiatric Clinical Trials. J Clin Psychopharmacol. 2025 Jan-Feb 01;45(1):28-31. doi: 10.1097/JCP.0000000000001936. Epub 2024 Nov 21. |
| Label | URL |
|---|---|
| STABIL-B Study Results | View source |
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IPD will be shared under an approved confidentiality agreement within one year of drug approval
Within one year of drug approval
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 9, 2023 | Mar 8, 2024 |
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Participants and Care Providers will be masked with regard to medication administered.
| Lurasidone HCl | Drug | Lurasidone HCl will be given twice a day by mouth |
|
|
| 6 weeks |
| Miami Lakes |
| Florida |
| 33014 |
| United States |
| ACMR | Atlanta | Georgia | 30331 | United States |
| iResearch Atlanta, LLC | Decatur | Georgia | 30030 | United States |
| iResearch Savannah | Savannah | Georgia | 31405 | United States |
| CBH Health | Gaithersburg | Maryland | 20877 | United States |
| Omaha Insomnia and Psychiatric Services | Omaha | Nebraska | 68144 | United States |
| Dent Neurologic Institute | Amherst | New York | 14226 | United States |
| Peace Health Medical Group | Eugene | Oregon | 97401 | United States |
| University of Texas Health Austin | Austin | Texas | 78712 | United States |
| Roots Behavioral Health | Austin | Texas | 78746 | United States |
| JPS Health | Fort Worth | Texas | 76104 | United States |
| Houston Mind and Brain | Houston | Texas | 77055 | United States |
| Health Texas | Richmond | Texas | 77407 | United States |
| Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 2, 2024 | Mar 8, 2024 | SAP_002.pdf |
| ID | Term |
|---|---|
| D001714 | Bipolar Disorder |
| D059020 | Suicidal Ideation |
| D001519 | Behavior |
| ID | Term |
|---|---|
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D013405 | Suicide |
| D016728 | Self-Injurious Behavior |
| D001526 | Behavioral Symptoms |
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| ID | Term |
|---|---|
| D000069056 | Lurasidone Hydrochloride |
| ID | Term |
|---|---|
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D054833 | Isoindoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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