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Scientists inject aggressive individuals with endotoxin to uncover Inflammation's role in anger

NCT ID NCT06665074

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study investigates whether inflammation worsens anger and aggression in people with Intermittent Explosive Disorder (IED). Researchers will give 112 participants (half with IED, half healthy controls) a low dose of endotoxin or a placebo on separate days. They will measure anger, aggressive behavior, brain activity, and inflammatory markers to see if those with IED react more strongly to inflammation.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Endotoxin (a substance that triggers temporary inflammation)
What this could lead to
If it works, this could help explain why some people become more aggressive when their body is inflamed, pointing toward new ways to treat impulsive aggression.
What could go wrong
This is an early-phase study with only 112 participants, so results may not apply to everyone. The endotoxin causes temporary flu-like symptoms, and the study is designed to understand mechanisms, not to test a treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 112 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2026

Expected to finish

Jan 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

21 to 55 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: "Aggressive Subjects" will have a current DSM-5 diagnosis of Intermittent Explosive Disorder (IED) and have a Life History of Aggression (LHA) \> 12. "Control Subjects" will not have current or past history of IED and will have LHA scores \< 11 ("Control Subjects" may have a past, but not current, history of Major Depression (MD), Generalized Anxiety Disorder (GAD), Panic Disorder (PDx), or Post-Traumatic Stress (PTSD) Disorder. Participant is between 21 and 55 years of age and is able to give informed consent. Participant is physically healthy as confirmed by medical history, physical evaluation, and (in females) a negative pregnancy test. Exclusion Criteria: Participants with a current clinically significant medical condition. Participants current co-morbid Major Depression (MD), Generalized Anxiety Disorder (GAD), Panic Disorder (PDx), or Post-Traumatic Stress (PTSD) Disorder. Participants currently taking prescribed medications for an active medical or psychiatric condition. Participants not free of prescribed medications for four weeks. Participants with Grade 2 or higher abnormalities on clinical laboratory examination (e.g., CBC with Differential, Metabolic Panel, and PT/INR/PTTa). Participants with Bradycardia (i.e., heart rate \< 50 beats/minute) or other Grade 2 or higher ECG abnormality. Participants with autoimmune conditions (e.g., asthma, psoriasis, etc.) Participants who are immunocompromised. Participants taking immunomodulatory, or anti-inflammatory, agents. Participants that are pregnant, breastfeeding, or plan to become pregnant within nine months of enrollment in the study. Female study participants of childbearing potential must remain abstinent or agree to use a highly effective form of contraception (e.g., an intrauterine device). Childbearing potential is defined as, study participants who have reached menarche and have not undergone a documented sterilization procedure (i.e., hysterectomy, bilateral oophorectomy, or salpingotomy), and have not reached menopause. Life history of bipolar disorder / schizophrenia / organic mental syndrome, or intellectual disability. Current alcohol / drug use disorder of greater than mild severity. Current suicidal ideation. History of a suicide attempt in the past year prior to study entry. Life history of \> 3 or more suicide attempts of any type. Life history of any moderately severe suicide attempt. Current or life history of homicidal ideation. Current or life history of felony assault and/or battery. Currently on parole for aggressive behavior. Allergy, or contraindication, to receiving endotoxin. Current treatment with opiates or any agents that affect pain threshold (exclusionary for the TAP). Unwilling/unable to sign informed consent document.

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Conditions

The condition(s) this trial relates to.

Aggression Disruptive, Impulse Control, and Conduct Disorders Inflammation intermittent explosive disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • The Ohio State University Medical Center

    RECRUITING

    Columbus, Ohio, 43210, United States

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