What is the mechanism of action of this treatment?

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.

What side effects are associated with this type of intervention?

Common treatments for depression and bipolar disorder, particularly those involving NMDA antagonists like ketamine, can have several side effects. Ketamine is known to cause dissociation, dizziness, nausea, vomiting, increased blood pressure, and potential cognitive impairment. Other treatments for depression, such as SSRIs and SNRIs, may lead to side effects like sexual dysfunction, weight gain, and gastrointestinal issues. For bipolar disorder, mood stabilizers and antipsychotics can cause weight gain, metabolic syndrome, and sedation. It is important to monitor these side effects closely and discuss them with a healthcare provider.

What prior FDA approvals exist?

Ketamine, an NMDA receptor antagonist, has been studied for its rapid antidepressant effects, particularly in treatment-resistant depression. The FDA has approved esketamine, a derivative of ketamine, for treatment-resistant depression and major depressive disorder with acute suicidal ideation or behavior. Esketamine is administered as a nasal spray and is used in conjunction with an oral antidepressant. Other treatments for bipolar disorder include mood stabilizers like lithium and anticonvulsants such as valproate, as well as second-generation antipsychotics like risperidone and quetiapine. These treatments are aimed at managing both manic and depressive episodes.

What other types of research exist?

Promising novel alternatives to NRX-100 for treating depression in bipolar disorder patients include: 1) Psilocybin-assisted psychotherapy, which has shown efficacy in treatment-resistant depression. 2) MDMA-assisted psychotherapy, which is being explored for PTSD and may have potential for depression. 3) D-cycloserine combined with lurasidone (NRX-101), which is being studied for maintenance of stabilization from depression and suicidal ideation. These treatments are emerging as potential options based on recent clinical research and trials.

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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

All Individual Drugs Already Approved

Approved for 5 Other Conditions

Pivotal Trial

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 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

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

Lightheadedness with low blood pressure

Pump Malfunction

PTSD

100%

80%

60%

40%

20%

Study treatment Arm

Ketamine

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

0 / 1Eligibility criteria met

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.