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New treatment option for Intermittent Explosive Disorder
Official title Inflammatory Challenge in Human Aggression.
ClinicalTrials.gov ID: NCT06665074
What this study is testing
What is Endotoxin (E. coli O:113, Reference Endotoxin)?
Endotoxin (E. coli O:113, Reference Endotoxin) is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for intermittent explosive disorder.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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").
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 to 55. Healthy volunteers may be eligible.
You may be able to join if
- "Aggressive people" will have a current DSM-5 diagnosis of Intermittent Explosive Disorder (IED) and have a Life History of Aggression (LHA) \> 12.
- "Control people" will not have current or past history of IED and will have LHA scores \< 11 ("Control people" may have a past, but not current...
- 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.
You likely can't join if
- 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)...
- 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.
See the full eligibility criteria
- "Aggressive people" will have a current DSM-5 diagnosis of Intermittent Explosive Disorder (IED) and have a Life History of Aggression (LHA) \> 12.
- "Control people" will not have current or past history of IED and will have LHA scores \< 11 ("Control people" may have a past, but not current, history of Major Depression (MD), Generalized Anxiety Disorder (GAD)...
- 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.
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Columbus, Ohio, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 21 years to 55 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Columbus, Ohio, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.