Inflammatory Challenge in Human Aggression.

Conditions

• Intermittent Explosive Disorder

Eligibility Criteria

Sex

ALL

Age

21 Years - 55 Years

Healthy Volunteers

Accepted

Interventions

• Endotoxin (E. coli O:113, Reference Endotoxin) — BIOLOGICAL
  Dosage of endotoxin is 0.8 ng/Kg body Weight
• Saline (Placebo) — OTHER
  Volume of saline to be the same as volume of endotoxin

Study Details

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 Dates

Start date

Feb 16, 2026

Status verified

Mar 2026

Primary completion

Jul 31, 2029

Completion

Jan 31, 2030

Study Design

Enrollment

112 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Arms

• Experimental: Aggressive Subjects
  Subjects with Intermittent Explosive Disorder (IED)
• Other: Non-Aggressive Subjects
  Subjects without IED

Primary Outcome Measure

Profile of Mood States (POMS) - Anger [ Time Frame: Before and during the Endotoxin/Placebo Infusion for up to six hours only on ach of the two study days.. ]

Central Contacts

• Emil F. Coccaro, MD
  7738521338
  [email protected]
• Julian Roberts, RN
  [email protected]

Locations (1)

Find similar trials in Columbus, OH

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