A Phase 2/3 interventional study of NRX-101 and Lurasidone HCl in Bipolar Depression and Suicidal Ideation and Behavior, sponsored by NeuroRx, Inc.. Completed at 14 sites in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-05-08.
Sponsored by NeuroRx, Inc. · Phase 2/3, Interventional, and Treatment
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:
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).
1,683 studies on the registry are indexed under Bipolar Disorder; 266 are open to participants now.
This study's enrollment of 74 is above the median of 64 across 1,279 interventional studies indexed under Bipolar Disorder.
Browse Bipolar Disorder studies →NeuroRx, Inc. is the lead sponsor of 9 studies on the registry; 3 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Subject has a lifetime history of:
Subject has been prescribed more than one agent in each of the following categories at randomization:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Following study enrollment and randomization, subjects will receive twice daily NRX-101
Drug: NRX-101
Following study enrollment, subjects will receive twice daily lurasidone
Drug: Lurasidone HCl
NRX-101, a fixed dose combination of D-cycloserine+lurasidone will be given twice a day by mouth
Lurasidone HCl will be given twice a day by mouth
Also known as: Latuda
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
Time frame: Six weeks
Mean Change from baseline in CGI-SS
Mean change from baseline to exit (Day 42/exit) in CGI-SS score
Time frame: 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)
Time frame: 6 weeks
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — IPD will be shared under an approved confidentiality agreement within one year of drug approval
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: Within one year of drug approval
Data sharing details ↗ · nrxpharma.com
Ran from May 2022 to primary completion in Feb 2024, 21 months.
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This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Desethyloxybutynin
NeuroRx, Inc.