NRX-101 for Bipolar Depression With Subacute Suicidal Ideation

Last updated: May 5, 2024
Sponsor: NeuroRx, Inc.
Overall Status: Completed

Phase

2/3

Condition

Depression

Depression (Treatment-resistant)

Suicide

Treatment

NRX-101

Lurasidone HCl

Clinical Study ID

NCT03395392
NRX101_003
  • Ages 18-65
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Diagnosed with bipolar disorder by a qualified rater according to the criteria definedin the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)and supported by the Mini International Neuropsychiatric Interview (MINI) 7.0.2.
  • Confirmed active suicidal ideation (without the intention to act) as evidenced by ananswer of 'Yes' on item 3 and/or item 4 and not requiring hospitalization at Screeningand an answer of "No" on item 5 of the C-SSRS.
  • A total score greater than or equal to 30 on the 10 items of the MADRS.
  • Subject has no co-morbidities as ascertained by medical history, physical examination (including measurement of vital signs), clinical laboratory evaluations, andelectrocardiogram (ECG)

Exclusion

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:
  • phencyclidine (PCP)/ketamine drug abuse, or
  • failed use of ketamine for depression or suicidality.
  • Subject has schizophrenia or schizoaffective disorder, or any history of psychoticsymptoms 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 atrandomization:
  • Approved SSRIs
  • Approved serotonin and norepinephrine reuptake inhibitors (SNRIs)
  • Approved tetracyclic antidepressants (TeCAs)
  • Approved Mood stabilizers (e.g., lithium, valproic acid, and lamotrigine)
  • Subject has signs and symptoms of active or residual COVID-19, or unresolved symptomsof COVID-19 that impact health

Study Design

Total Participants: 74
Treatment Group(s): 2
Primary Treatment: NRX-101
Phase: 2/3
Study Start date:
May 12, 2022
Estimated Completion Date:
March 30, 2024

Study Description

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:

  • To test the hypothesis that treatment with NRX-101 is superior to standard of care (lurasidone) in improving symptoms of depression as measured by the total Montgomery Åsberg Depression Rating Scale (MADRS-10) score in patients with bipolar depression and subacute suicidal ideation and behavior (SSIB) which does not require hospitalization.

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).

Connect with a study center

  • Science 37

    Culver City, California 90320
    United States

    Site Not Available

  • San Marcus Research Clinic, Inc.

    Miami Lakes, Florida 33014
    United States

    Site Not Available

  • ACMR

    Atlanta, Georgia 30331
    United States

    Site Not Available

  • iResearch Atlanta, LLC

    Decatur, Georgia 30030
    United States

    Site Not Available

  • iResearch Savannah

    Savannah, Georgia 31405
    United States

    Site Not Available

  • CBH Health

    Gaithersburg, Maryland 20877
    United States

    Site Not Available

  • Omaha Insomnia and Psychiatric Services

    Omaha, Nebraska 68144
    United States

    Site Not Available

  • Dent Neurologic Institute

    Amherst, New York 14226
    United States

    Site Not Available

  • Peace Health Medical Group

    Eugene, Oregon 97401
    United States

    Site Not Available

  • Roots Behavioral Health

    Austin, Texas 78746
    United States

    Site Not Available

  • University of Texas Health Austin

    Austin, Texas 78712
    United States

    Site Not Available

  • JPS Health

    Fort Worth, Texas 76104
    United States

    Site Not Available

  • Houston Mind and Brain

    Houston, Texas 77055
    United States

    Site Not Available

  • Health Texas

    Richmond, Texas 77407
    United States

    Site Not Available

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