What is the mechanism of action of this treatment?

Intermittent Explosive Disorder (IED) is often treated with medications that target neurotransmitter systems to stabilize mood and reduce impulsive aggression. Common treatments include selective serotonin reuptake inhibitors (SSRIs) like fluoxetine, which increase serotonin levels in the brain, and mood stabilizers such as lithium, which modulate neurotransmitter release and neuronal excitability. The study of nitrous oxide inhalation for IED is particularly relevant as it explores the modulation of cortico-limbic circuits, which are involved in emotional regulation and impulse control. By potentially normalizing these brain circuits, nitrous oxide could offer a novel approach to managing the impulsive aggression characteristic of IED, providing an alternative to traditional pharmacotherapy.

What side effects are associated with this type of intervention?

Common treatments for Intermittent Explosive Disorder (IED) include medications such as selective serotonin reuptake inhibitors (SSRIs), mood stabilizers, and antipsychotics. Treatments similar to nitrous oxide inhalation, which modulate neurocircuit function, may include SSRIs and other medications that affect neurotransmitter systems. Known side effects of these treatments can include nausea, headache, dizziness, weight gain, and sexual dysfunction for SSRIs; drowsiness, tremors, and gastrointestinal issues for mood stabilizers; and sedation, weight gain, and metabolic changes for antipsychotics. It is important to discuss these potential side effects with a healthcare provider to determine the best treatment plan.

What prior FDA approvals exist?

There are no specific FDA-approved medications for Intermittent Explosive Disorder (IED). However, treatments often include medications such as selective serotonin reuptake inhibitors (SSRIs), mood stabilizers, and antipsychotics, which aim to manage symptoms by modulating brain chemistry and neurocircuit function. While nitrous oxide inhalation is being studied for its potential to normalize brain circuit function in impulsively aggressive individuals, it is not yet an established treatment for IED.

What other types of research exist?

Promising novel alternatives to nitrous oxide inhalation for treating Intermittent Explosive Disorder (IED) include: 1) Transcranial Magnetic Stimulation (TMS), which uses magnetic fields to stimulate nerve cells in the brain and has shown efficacy in modulating neurocircuit function. 2) Deep Brain Stimulation (DBS), an invasive technique that involves implanting electrodes in specific brain areas to regulate abnormal impulses. 3) Pharmacological agents such as glutamate modulators and serotonin-norepinephrine reuptake inhibitors (SNRIs), which target neurotransmitter systems involved in aggression and impulse control.

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Nitrous Oxide for Aggression

Phase 2

Recruiting

Led By Emil Coccaro, M.D.

Research Sponsored by Ohio State University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Physically healthy (no clinically significant medical condition as confirmed by medical history/physical exam).

Between 21 and 55 years of age.

Must not have

Current DSM-5 Major Depressive Episode.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 hours after nitrous oxide and room air

Summary

This trial tests if inhaling nitrous oxide can help normalize brain function in people with impulsive aggression. Participants with and without aggressive tendencies will inhale the gas and undergo brain scans to see if it improves their brain activity. The goal is to find a potential treatment for those with Intermittent Explosive Disorder. Nitrous oxide has been shown to reduce involuntary movements in cerebral palsy patients, indicating its potential to affect brain function.

Who is the study for?

This trial is for adults aged 21-55 with Intermittent Explosive Disorder (IED) and high aggression scores, but no major psychiatric disorders like psychosis or bipolar disorder, nor current severe substance abuse. Healthy participants without any psychiatric conditions and low aggression can also join.

What is being tested?

Researchers are testing if inhaling Nitrous Oxide changes brain function in people with impulsive aggression compared to healthy controls. Participants breathe in either Nitrous Oxide or room air for an hour and have a brain scan the next day.

What are the potential side effects?

While not explicitly listed here, common side effects of Nitrous Oxide may include dizziness, nausea, fatigue, headache or euphoria shortly after inhalation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am physically healthy with no significant medical conditions.

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I am between 21 and 55 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently experiencing a major depressive episode.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 hours after nitrous oxide and room air

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 hours after nitrous oxide and room air

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 hours after nitrous oxide and room air for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Brain Connectivity

Cortico-Limbic Response to Anger Faces

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Nitrous Oxide InhalationActive Control1 Intervention

60 minute session inhaling Nitrous Oxide gas.

Group II: Room AirPlacebo Group1 Intervention

60 minute session inhaling Room Air.

0 / 3Eligibility 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

Intermittent Explosive Disorder (IED) is often treated with medications that target neurotransmitter systems to stabilize mood and reduce impulsive aggression. Common treatments include selective serotonin reuptake inhibitors (SSRIs) like fluoxetine, which increase serotonin levels in the brain, and mood stabilizers such as lithium, which modulate neurotransmitter release and neuronal excitability. The study of nitrous oxide inhalation for IED is particularly relevant as it explores the modulation of cortico-limbic circuits, which are involved in emotional regulation and impulse control. By potentially normalizing these brain circuits, nitrous oxide could offer a novel approach to managing the impulsive aggression characteristic of IED, providing an alternative to traditional pharmacotherapy.

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