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NMDA Antagonist
NRX101 for Bipolar Depression (MBD Trial)
Phase 2 & 3
Waitlist Available
Research Sponsored by NeuroRx, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 weeks
Awards & highlights
MBD Trial Summary
This trial will test whether NRX-101, a combination of two drugs, is better than lurasidone alone at treating bipolar depression and reducing suicidal thoughts or behavior.
Who is the study for?
This trial is for adults with bipolar depression who currently have suicidal thoughts but don't need hospitalization. They must score ≥30 on the MADRS, a depression rating scale, and meet DSM-5 criteria for bipolar disorder without other major psychiatric disorders or recent substance abuse.Check my eligibility
What is being tested?
The study compares NRX-101, a combination of D-cycloserine and lurasidone, to lurasidone alone in maintaining remission from bipolar depression and reducing suicidal thoughts over six weeks with twice-daily oral dosing.See study design
What are the potential side effects?
Potential side effects may include those commonly associated with NMDA antagonists such as dizziness, nausea, headache; or antipsychotics like lurasidone which can cause restlessness, muscle stiffness, weight gain.
MBD Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ six weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~six weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change from Baseline in MADRS-10 over 42 Days
Secondary outcome measures
Mean Change from baseline in CGI-SS
Time to Treatment Failure
MBD Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: NRX-101Experimental Treatment1 Intervention
Following study enrollment and randomization, subjects will receive twice daily NRX-101
Group II: LurasidoneActive Control1 Intervention
Following study enrollment, subjects will receive twice daily lurasidone
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
NRX-101
2022
Completed Phase 3
~90
Find a Location
Who is running the clinical trial?
Prevail Infoworks, IncUNKNOWN
2 Previous Clinical Trials
170 Total Patients Enrolled
NeuroRx, Inc.Lead Sponsor
12 Previous Clinical Trials
1,085 Total Patients Enrolled
Fred Grossman, DOStudy DirectorChief Medical Officer, NeuroRx, Inc.
2 Previous Clinical Trials
672 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I don't have other major health issues as confirmed by recent medical exams.I don't have any other major health issues.I am experiencing ongoing or residual symptoms from COVID-19.You have recently thought about hurting yourself, but don't have immediate plans to do so and are not currently in the hospital.I have been prescribed multiple medications for depression or mood stabilization.
Research Study Groups:
This trial has the following groups:- Group 1: NRX-101
- Group 2: Lurasidone
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Depression, Bipolar Disorder Patient Testimony for trial: Trial Name: NCT03395392 — Phase 2 & 3
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