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New treatment option for Intermittent Explosive Disorder
Official title Effect of Nitrous Oxide on Aggression.
ClinicalTrials.gov ID: NCT06118567
What this study is testing
What is Nitrous oxide?
Nitrous oxide 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 experimental medicine clinical trial is to test the hypothesis that nitrous oxide inhalation will result in a change in neurocircuit function in healthy controls and in individuals with impulsive aggressive tendencies. The main question aims to answer are: Does Nitrous Oxide normalize brain circuit function in impulsively aggressive individuals 24 hours after inhalation.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. 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
- All participants:
- Between 21 and 55 years of age.
- Physically healthy (no clinically significant medical condition as confirmed by medical history/physical exam).
- Able to give informed consent. Aggressive (IED) Study Participants (n = 25 Completed; 75 Enrolled).
- Current DSM-5 Criteria for IED
You likely can't join if
- PCL Screening Version Score \> 13; i.e., subject is likely to be psychopathic.32
- Current DSM-5 Major Depressive Episode.
- Life history of bipolar disorder/schizophrenia/organic mental syndrome.
- Intellectual disability [i.e., IQ \< 70].
- History of N2O abuse/dependence.
- Clinically significant medical condition.
See the full eligibility criteria
- All participants:
- Between 21 and 55 years of age.
- Physically healthy (no clinically significant medical condition as confirmed by medical history/physical exam).
- Able to give informed consent. Aggressive (IED) Study Participants (n = 25 Completed; 75 Enrolled).
- Current DSM-5 Criteria for IED
- LHA Aggression scores \> 12
- Negative for a history of psychosis, bipolar disorder, developmental disorder, intellectual disability or a current substance use disorder. Healthy, Non-Aggressive, Controls (n = 25 Completed, 75 Enrolled).
- Do not meet current/lifetime DSM-5 Criteria for any psychiatric disorder
- LHA aggression scores \< 12
- PCL Screening Version Score \> 13; i.e., subject is likely to be psychopathic.32
- Current DSM-5 Major Depressive Episode.
- Life history of bipolar disorder/schizophrenia/organic mental syndrome.
- Intellectual disability [i.e., IQ \< 70].
- History of N2O abuse/dependence.
- Clinically significant medical condition.
- Current alcohol/drug use disorder of moderate or severe severity (i.e., subject is not in full remission from moderate to severe alcohol/drug use).
- Two weeks free of antipsychotic medication. (Note: Because a large number of individuals with aggressive tendencies in the community are already taking SSRIs, SNRIs, or mood stabilizers, these individuals will not be...
- 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.