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Virus Therapy

Endotoxin for Aggression (LPSS Trial)

Phase 2

Waitlist Available

Led By Emil F. Coccaro, MD

Research Sponsored by Ohio State University

Eligibility Criteria Checklist

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

Must have

Aggressive Subjects will have a current DSM-5 diagnosis of Intermittent Explosive Disorder (IED) and have a Life History of Aggression (LHA) > 12

Participant is between 21 and 55 years of age and is able to give informed consent

Must not have

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up once during the endotoxin infusion and once during the salin infusion only. the mri scan takes 90 minutes on each of the two study days.

Summary

This trial aims to study how individuals with a history of frequent, problematic, impulsive aggression respond to a low dose of endotoxin compared to individuals without this history. Endotoxin is a substance

Who is the study for?

This trial is for individuals with a history of frequent, impulsive aggression ('aggressives') and those without such a history ('controls'). Participants will be given endotoxin or placebo through an IV on separate days and undergo behavioral tests and MRI scans. Specific eligibility criteria are not provided.

What is being tested?

The study investigates how people with aggressive tendencies react to low-dose endotoxin—a substance causing inflammation—compared to non-aggressive controls. It measures anger, aggression responses, emotional reactions, inflammatory markers in the blood, and brain activity during MRI scans.

What are the potential side effects?

Possible side effects include typical responses to inflammation like fever, fatigue, headache or muscle pain due to the endotoxin infusion. The saline placebo should have no side effects except for potential discomfort from IV insertion.

Eligibility Criteria

Inclusion Criteria

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

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I have been diagnosed with Intermittent Explosive Disorder and have a high aggression history.

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I am between 21 and 55 years old and can legally consent.

Exclusion Criteria

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

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I am currently taking medication that affects my immune system.

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I am not pregnant, breastfeeding, nor planning to become pregnant soon.

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I am currently having thoughts about harming myself.

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I have attempted suicide in the past.

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I have a serious health condition right now.

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I have been diagnosed with depression, anxiety, panic disorder, or PTSD.

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My heart rate is below 50 beats per minute or I have a significant ECG abnormality.

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I am not currently taking opiates or any pain threshold altering drugs.

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I am currently on medication for an ongoing health or mental condition.

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My blood tests show significant abnormalities.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ before and during the endotoxin/placebo infusion for up to six hours only on ach of the two study days..

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~before and during the endotoxin/placebo infusion for up to six hours only on ach of the two study days..

This trial's timeline: 3 weeks for screening, Varies for treatment, and before and during the endotoxin/placebo infusion for up to six hours only on ach of the two study days.. for reporting.