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RECRUITING

NCT06665074

PHASE2

Inflammatory Challenge in Human Aggression.

Sponsor: Ohio State University

View on ClinicalTrials.gov

Summary

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.

Key Details

Gender

All

Age Range

21 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

112

Start Date

2026-02-16

Completion Date

2030-01

Last Updated

2026-03-27

Healthy Volunteers

Yes

Conditions

Intermittent Explosive Disorder

Interventions

BIOLOGICAL

Endotoxin (E. coli O:113, Reference Endotoxin)

Dosage of endotoxin is 0.8 ng/Kg body Weight

OTHER

Saline (Placebo)

Volume of saline to be the same as volume of endotoxin

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.

Locations (1)

The Ohio State University Medical Center

Columbus, Ohio, United States