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NMDA Antagonist

Ketamine for Bipolar Depression and Suicidal Thoughts (SevereBD 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
18 to 65 years of age, inclusive, at screening.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 hours
Awards & highlights

Summary

This trial tests a treatment that starts with a ketamine injection to quickly reduce severe depression and suicidal thoughts, followed by maintenance pills. It targets patients with severe bipolar depression who need rapid symptom relief. Ketamine rapidly alters brain activity, and the pills help maintain these positive changes. Ketamine has shown effectiveness as a rapid-acting antidepressant with antisuicidal effects, but evidence for long-term maintenance therapy is limited.

Who is the study for?
This trial is for adults aged 18-65 with severe bipolar depression and recent suicidal thoughts or behaviors. Participants must understand the study, be likely to follow its rules, have a stable living situation, and use effective birth control if applicable. They can't join if they're pregnant or don't meet health requirements.
What is being tested?
The trial tests NRX-100 (ketamine HCL) against a placebo for quick relief of depression and suicidal thoughts in bipolar disorder patients. It aims to see if NRX-100 works better than a placebo within 24 hours after taking it.
What are the potential side effects?
Ketamine may cause side effects like disorientation, dizziness, nausea, increased blood pressure, mood swings, blurred vision, and potentially abuse or dependency issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 18 and 65 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Suicidal Ideation
Secondary study objectives
Depression

Side effects data

From 2020 Phase 4 trial • 75 Patients • NCT03156504
1%
Lightheadedness with low blood pressure
1%
Pump Malfunction
1%
PTSD
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ketamine

Trial Design

2Treatment groups
Experimental Treatment
Group I: Saline (placebo) infusionExperimental Treatment1 Intervention
Infusion of IV Saline
Group II: NRX-100 infusionExperimental Treatment1 Intervention
Infusion of IV NRX-100 (ketamine)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ketamine
FDA approved
Placebo
1995
Completed Phase 3
~2670

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
Common treatments for Depression and Bipolar Disorder include NMDA antagonists like Ketamine HCL, which work by blocking the NMDA receptors in the brain, leading to rapid antidepressant effects and reduction in suicidal ideation. This mechanism is crucial as it offers a fast-acting alternative for treatment-resistant cases. Other treatments include mood stabilizers like lithium, which modulate neurotransmitter activity to stabilize mood swings, and antipsychotics that target dopamine and serotonin receptors to manage psychotic symptoms. Understanding these mechanisms helps tailor treatments to individual patient needs, improving outcomes and managing symptoms more effectively.
Relative effectiveness of augmentation treatments for treatment-resistant depression: a systematic review and network meta-analysis.Glutamatergic drugs for schizophrenia.

Find a Location

Who is running the clinical trial?

NeuroRx, Inc.Lead Sponsor
12 Previous Clinical Trials
1,009 Total Patients Enrolled
Target Health Inc.Industry Sponsor
6 Previous Clinical Trials
370 Total Patients Enrolled
Martin Brecher, MDStudy DirectorVP, Clinical Development, NeuroRx, Inc.
5 Previous Clinical Trials
1,130 Total Patients Enrolled
~7 spots leftby Dec 2024
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