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Inflammatory Challenge in Human Aggression
NCT06665074Phase 2
Key facts
- Status
- Recruiting
- Start
- Feb 2026
- Primary completion
- Jul 2029
- Countries
- 1
- Sponsor
- The Ohio State University
- Modality
- Biologic
01
Overview
Phase 2, randomised, double-blind trial of lipopolysaccharide endotoxin (2 arms), sponsored by The Ohio State University. Primary endpoint: Profile of Mood States - Anger up to 6 hours. Started Feb 2026; status: recruiting.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Aggressive Subjects
Subjects with Intermittent Explosive Disorder (IED) receiving both Endotoxin and Placebo on separate days.
Non-Aggressive Subjects
Subjects without IED receiving both Endotoxin and Placebo on separate days.
03
Who it enrols
Participants must be 21-55 years old, physically healthy, and free of prescribed medications for 4 weeks. The 'Aggressive' group must have a DSM-5 diagnosis of Intermittent Explosive Disorder (IED) and a Life History of Aggression (LHA) > 12, while the 'Control' group must have no history of IED and an LHA < 11. Exclusions include current comorbid psychiatric disorders, autoimmune conditions, pregnancy, suicidal ideation, and recent substance abuse.
04
Endpoints
Primary
Profile of Mood States - Anger
Secondary
Taylor Aggression Paradigm
Video-Social Emotional Information Processing
Pro-Inflammatory Cytokines (IL-6, TNF-Alpha)
Functional MRI
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