NRX-101 for Bipolar Depression With Subacute Suicidal Ideation
A Randomized, Double-Blind Controlled Comparison of NRX-101 to Lurasidone for Adults With Bipolar Depression and Subacute Suicidal Ideation or Behavior
1 other identifier
interventional
74
1 country
14
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started May 2022
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 4, 2018
CompletedFirst Posted
Study publicly available on registry
January 10, 2018
CompletedStudy Start
First participant enrolled
May 12, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
March 30, 2024
CompletedMay 8, 2024
March 1, 2024
1.8 years
January 4, 2018
May 5, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (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
Six weeks
Secondary Outcomes (2)
Mean Change from baseline in CGI-SS
Six Weeks
Time to Treatment Failure
6 weeks
Study Arms (2)
NRX-101
EXPERIMENTALFollowing study enrollment and randomization, subjects will receive twice daily NRX-101
Lurasidone
ACTIVE COMPARATORFollowing study enrollment, subjects will receive twice daily lurasidone
Interventions
NRX-101, a fixed dose combination of D-cycloserine+lurasidone will be given twice a day by mouth
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- NeuroRx, Inc.lead
- Prevail Infoworkscollaborator
Study Sites (14)
Science 37
Culver City, California, 90320, United States
San Marcus Research Clinic, Inc.
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
Related Publications (1)
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.
PMID: 39714786DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Martin Brecher, MD
NRx Pharma
- STUDY CHAIR
Andrew A Nierenberg, MD
Harvard Medical School (HMS and HSDM)
- STUDY CHAIR
Jonathan C Javitt, MD, MPH
NRx Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Participants and Care Providers will be masked with regard to medication administered.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
- Expanded Access
- Yes
Study Record Dates
First Submitted
January 4, 2018
First Posted
January 10, 2018
Study Start
May 12, 2022
Primary Completion
February 28, 2024
Study Completion
March 30, 2024
Last Updated
May 8, 2024
Record last verified: 2024-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- Within one year of drug approval
IPD will be shared under an approved confidentiality agreement within one year of drug approval