Actively Recruiting
Inflammatory Challenge in Human Aggression.
Led by Ohio State University · Updated on 2026-03-27
112
Participants Needed
1
Research Sites
202 weeks
Total Duration
On this page
Sponsors
O
Ohio State University
Lead Sponsor
N
National Institute of Mental Health (NIMH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of this clinical trial is to explore the differences in behavioral and cytokine response to a low dose infusion of endotoxin (vs. placebo) in individuals with histories of frequent, problematic, impulsive aggression ("aggressives") compared to similar individuals without this history ("controls"). Endotoxin is a substance that produces a reliable inflammation response in human subjects. The main questions it aims to answer are: * Do aggressive individuals have greater self-rated anger responses to low-dose endotoxin compared with controls? * Do aggressive individuals have greater analog aggressive responses (in the Taylor Aggression Paradigm) to low-dose endotoxin compared with controls? * Do aggressive individuals have greater hostile attributional and negative emotional responses (in the V-SEIP) to low-dose endotoxin compared with controls? * Do aggressive individuals have greater plasma pro-inflammatory responses to low-dose endotoxin compared with controls? * Do aggressive individuals display a greater activation of brain responses to anger-related picture during an MRI scan during low-dose endotoxin compared with controls? Researchers will compare endotoxin to a placebo (a look-alike substance that contains no drug) explore the differences in behavioral and cytokine response to a low dose infusion of endotoxin (vs. placebo) in individuals with histories of frequent, problematic, impulsive aggression ("aggressives") compared to similar individuals without this history ("controls"). Participants will: * Receive a low-dose of endotoxin and placebo on two (2) separate days. The study drugs will be given through a plastic tube inserted in a forearm vein. * Visit the laboratory on at least two (2) separate days to receive the endotoxin and placebo. * Complete rating forms, behavioral testing, and an MRI on each of the two (2) laboratory days.
CONDITIONS
Official Title
Inflammatory Challenge in Human Aggression.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must be between 21 and 55 years old and able to give informed consent.
- "Aggressive Subjects" must have a current DSM-5 diagnosis of Intermittent Explosive Disorder (IED) and a Life History of Aggression (LHA) score greater than 12.
- "Control Subjects" must have no current or past history of IED and an LHA score less than 11.
- Control subjects may have a past, but not current, history of Major Depression, Generalized Anxiety Disorder, Panic Disorder, or Post-Traumatic Stress Disorder.
- Participants must be physically healthy based on medical history and physical evaluation.
- Female participants must have a negative pregnancy test before enrollment.
You will not qualify if you...
- Participants with any current clinically significant medical condition.
- Participants with current Major Depression, Generalized Anxiety Disorder, Panic Disorder, or Post-Traumatic Stress Disorder.
- Participants currently taking prescribed medications for active medical or psychiatric conditions.
- Participants not free from prescribed medications for at least four weeks.
- Participants with Grade 2 or higher abnormalities on laboratory tests (e.g., CBC, metabolic panel).
- Participants with bradycardia (heart rate below 50 beats per minute) or significant ECG abnormalities.
- Participants with autoimmune conditions such as asthma or psoriasis.
- Participants who are immunocompromised.
- Participants taking immunomodulatory or anti-inflammatory drugs.
- Participants who are pregnant, breastfeeding, or plan pregnancy within nine months.
- Female participants of childbearing potential must use effective contraception or remain abstinent.
- Participants with a history of bipolar disorder, schizophrenia, organic mental syndrome, or intellectual disability.
- Participants with current moderate to severe alcohol or drug use disorders.
- Participants with current suicidal ideation or recent suicide attempts.
- Participants with a history of multiple or severe suicide attempts.
- Participants with current or past homicidal ideation.
- Participants with felony assault or battery history or currently on parole for aggressive behavior.
- Participants allergic or contraindicated to endotoxin.
- Participants currently treated with opiates or agents affecting pain threshold.
- Participants unwilling or unable to provide informed consent.
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Trial Site Locations
Total: 1 location
1
The Ohio State University Medical Center
Columbus, Ohio, United States, 43210
Actively Recruiting
Research Team
E
Emil F. Coccaro, MD
CONTACT
J
Julian Roberts, RN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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