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NMDA Antagonist

NRX-101 for Bipolar Depression (SBD-ASIB Trial)

Phase 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
Diagnosed with bipolar disorder (BD) according to the criteria defined in the DSM-5
18 to 65 years of age, able to understand and provide written and dated informed consent prior to screening
Must not have
Clinically significant abnormality on the screening physical examination
Any major psychiatric disorder clinically predominant to BD at screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up six weeks
Awards & highlights

Summary

This trial will test whether a new drug is better than another drug at reducing symptoms of depression and suicidal ideation over a six-week period.

Who is the study for?
Adults aged 18-65 with severe bipolar depression and suicidal thoughts, responding to initial treatment under NCT03396601. Participants must be in good health, have a stable living situation, reliable informant, and if female, use effective birth control or be non-childbearing. Excludes those with other major psychiatric disorders as primary focus or certain physical conditions.Check my eligibility
What is being tested?
The trial tests NRX-101 for maintaining remission from severe bipolar depression after initial stabilization with IV ketamine (NRX-100). NRX-101 is compared to Lurasidone alone over six weeks of oral dosing. The study aims to see if NRX-101 better prevents relapse and reduces suicidal thoughts.See study design
What are the potential side effects?
Possible side effects include typical antidepressant risks like nausea, headaches, dizziness but also may involve unique reactions due to the novel combination of D-cycloserine and lurasidone in NRX-101.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with bipolar disorder.
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I am between 18 and 65 years old and can understand and sign a consent form.
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I am not able to have children or I am using reliable birth control.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My screening exam showed a significant health issue.
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I have a major psychiatric condition more prominent than bipolar disorder.
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I am not willing to use birth control as required.
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I am currently pregnant or breastfeeding.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
MADRS-10
Secondary outcome measures
Time to Relapse (stage 2)

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: NRX-101Experimental Treatment1 Intervention
Subjects will be treated with oral NRX-101 (fixed dose combination of D-Cycloserine/lurasidone) that will be titrated to a combined dose of 950mg/66mg per day.
Group II: Lurasidone comparatorActive Control1 Intervention
Subjects will be treated with oral lurasidone in a matched placebo capsule that will be titrated to a dose of 66 mg per day
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
NRX-101
2022
Completed Phase 3
~90

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
NMDA antagonists, such as ketamine, work by blocking the N-methyl-D-aspartate (NMDA) receptor, which is involved in glutamate neurotransmission. This can lead to rapid antidepressant effects and reduction in suicidal ideation, making them valuable for treatment-resistant depression and severe bipolar depression. Serotonin-dopamine antagonists, like lurasidone, block serotonin and dopamine receptors, helping to stabilize mood and reduce symptoms of mania and depression. These mechanisms are crucial as they offer alternative pathways for patients who do not respond to traditional treatments, providing hope for more effective management of their conditions.
Relative effectiveness of augmentation treatments for treatment-resistant depression: a systematic review and network meta-analysis.

Find a Location

Who is running the clinical trial?

NeuroRx, Inc.Lead Sponsor
12 Previous Clinical Trials
1,087 Total Patients Enrolled
Vanguard, IncUNKNOWN
Target Health Inc.Industry Sponsor
6 Previous Clinical Trials
448 Total Patients Enrolled

Media Library

NRX-101 (NMDA Antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT03396068 — Phase 3
Depression, Bipolar Disorder Research Study Groups: Lurasidone comparator, NRX-101
Depression, Bipolar Disorder Clinical Trial 2023: NRX-101 Highlights & Side Effects. Trial Name: NCT03396068 — Phase 3
NRX-101 (NMDA Antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03396068 — Phase 3
~6 spots leftby Dec 2024