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Bipolar DepressionPhase 2/3NCT03395392

NRX-101 for Bipolar Depression With Subacute Suicidal Ideation

A Phase 2/3 study testing NRX-101 and Lurasidone HCl in people with Bipolar Depression and Suicidal Ideation and Behavior, run by NeuroRx, Inc. at 14 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
NRX-101 and Lurasidone HCl
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
74 participants
Where
14 sitesUnited States
Study dates
12 May 2022to 30 Mar 2024
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosed with bipolar disorder by a qualified rater according to the criteria defined in 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 an answer of 'Yes' on item 3 and/or item 4 and not requiring hospitalization at Screening and 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, and electrocardiogram (ECG)

Who cannot join

  • 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 psychotic symptoms when not in an acute bipolar mood episode.
  • Subject has a current major psychiatric disorder, diagnosed at Screening
Show all 12Show fewer
  • Subject has been prescribed more than one agent in each of the following categories at randomization:
  • 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 symptoms of COVID-19 that impact health

Trial locations and contacts

14 sites in 1 country.

14 sites in 1 country

United States14 sites

  • Dent Neurologic Institute

    Amherst, New York, 14226

  • ACMR

    Atlanta, Georgia, 30331

  • University of Texas Health Austin

    Austin, Texas, 78712

  • Roots Behavioral Health

    Austin, Texas, 78746

  • Science 37

    Culver City, California, 90320

  • iResearch Atlanta, LLC

    Decatur, Georgia, 30030

  • Peace Health Medical Group

    Eugene, Oregon, 97401

  • JPS Health

    Fort Worth, Texas, 76104

  • CBH Health

    Gaithersburg, Maryland, 20877

  • Houston Mind and Brain

    Houston, Texas, 77055

  • San Marcus Research Clinic, Inc.

    Miami Lakes, Florida, 33014

  • Omaha Insomnia and Psychiatric Services

    Omaha, Nebraska, 68144

  • Health Texas

    Richmond, Texas, 77407

  • iResearch Savannah

    Savannah, Georgia, 31405

Other trials in United States

About this study

Official title: A Randomized, Double-Blind Controlled Comparison of NRX-101 to Lurasidone for Adults With Bipolar Depression and Subacute Suicidal Ideation or Behavior

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.

Read the detailed 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).

Being tested
NRX-101, Lurasidone HCl
Keywords
Bipolar, Cyloserine, Lurasidone, MADRS, CGI-SS, C-SSRS
Medical subject headings
Bipolar Disorder, Suicidal Ideation, Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NRX-101Drug

    NRX-101, a fixed dose combination of D-cycloserine+lurasidone will be given twice a day by mouth

  • Lurasidone HClDrug

    Also called Latuda

    Lurasidone HCl will be given twice a day by mouth

Study groups in NCT03395392
Study groupRoleWhat they receive
NRX-101ExperimentalFollowing study enrollment and randomization, subjects will receive twice daily NRX-101
Receives: Drug: NRX-101
LurasidoneActive comparatorFollowing study enrollment, subjects will receive twice daily lurasidone
Receives: Drug: Lurasidone HCl

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Six weeks

Secondary outcomes (2)

  1. Mean Change from baseline in CGI-SS

    Mean change from baseline to exit (Day 42/exit) in CGI-SS score

    Measured: Six Weeks

  2. 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)

    Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jan 2018
  2. Study start12 May 2022
  3. Primary completion28 Feb 2024
  4. Study completion30 Mar 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
74 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03395392
Sponsor's protocol ID
NRX101_003
Status last verified
Mar 2024
First submitted
4 Jan 2018
Last updated
8 May 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: IPD will be shared under an approved confidentiality agreement within one year of drug approval
Expanded access
Available

Publications

  • 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.

    PubMed 39714786

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing NRX-101 and Lurasidone HCl in people with Bipolar Depression and Suicidal Ideation and Behavior, run by NeuroRx, Inc. at 14 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline in MADRS-10 over 42 Days (time frame: Six weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03395392, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2024.

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Clinical Trial NCT03395392 | AzTrials