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NMDA Antagonist

Ketamine Hydrochloride for Depression, Bipolar Disorder (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

SevereBD Trial Summary

This trial will test whether NRX-100, a drug that reduces symptoms of depression and suicidal ideation, is better than placebo in treating patients with severe bipolar depression and acute suicidal ideation or behavior.

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.Check my eligibility

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.See study design

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.

SevereBD Trial 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.

SevereBD Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 hours

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Suicidal Ideation

Secondary outcome measures

Depression

Side effects data

From 2020 Phase 4 trial • 75 Patients • NCT03156504

Lightheadedness with low blood pressure

Pump Malfunction

PTSD

100%

80%

60%

40%

20%

Study treatment Arm

Ketamine

SevereBD 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

Placebo

1995

Completed Phase 3

~2670

Ketamine

FDA approved

0 / 1Eligibility criteria met

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?

Texas

How old are they?

18 - 65

What site did they apply to?

JP Smith Hospital

What portion of applicants met pre-screening criteria?

Did not meet criteria

Met criteria

Why did patients apply to this trial?

I have been suffering from major depression/bipolar for several years without finding a long term solution that works.

PatientReceived 2+ prior treatments

I have experienced ongoing bipolar depression for years that appears to be treatment resistant. I’d like the opportunity to try ketamine as it has been beneficial to friends with similar struggles.

PatientReceived no prior treatments

I've tried many different medications to find relief from my disorder and I still feel like I'm not getting the most out of life. It is debilitating, I see people i know enjoying life, having normal happy experiences and I just want to have that too.

PatientReceived 1 prior treatment

Recent research and studies

clinicaltrials.govStudy

NRX100 vs. Placebo for Rapid Stabilization of Acute Suicidal Ideation and Behavior in Bipolar Depression

2019. "NRX100 vs. Placebo for Rapid Stabilization of Acute Suicidal Ideation and Behavior in Bipolar Depression". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03396601.

All > Depression Dallas > Bipolar Disorder