Using Pimavanserin to Reduce Aggression in Intermittent Explosive Disorder
Effect of Pimavanserin on Aggression and Social Cognition.
This study is testing whether a single dose of pimavanserin can help reduce aggressive behavior in people with Intermittent Explosive Disorder.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 35 (estimated) |
| Ages | 21 Years to 55 Years |
| Sex | All |
| Sponsor | Ohio State University Academic / other |
| Locations | 1 site (Columbus, Ohio) |
| Trial ID | NCT05895513 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of a single oral dose of 34 mg of pimavanserin, a 5-HT2a receptor antagonist, on reducing aggressive behavior in individuals diagnosed with Intermittent Explosive Disorder (IED). Participants will undergo a remote screening followed by an in-person session where they will complete interviews, questionnaires, and medical evaluations. The study aims to assess aggression levels using the Taylor Aggression Paradigm and examine the drug's impact on hostile social cognition. If successful, a subsequent placebo-controlled trial may follow.
Who should consider this trial
Good fit: Ideal candidates are adults aged 21 to 55 with a diagnosis of Intermittent Explosive Disorder or a high score on the Life History of Aggression scale.
Not a fit: Patients with significant medical conditions, severe psychiatric disorders, or those currently using certain medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce aggressive outbursts in patients with Intermittent Explosive Disorder.
How similar studies have performed: While the approach of using pimavanserin is novel for this specific condition, previous studies have indicated a potential link between serotonin modulation and aggression, suggesting a promising avenue for treatment.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Participants will have a current (or past) DSM-5 diagnosis of Intermittent Explosive Disorder (IED) or have a Life History of Aggression (LHA) score equal or greater than 12. In addition, all participants must meet the following criteria: 1. Participant is between 21 and 55 years of age and is able to give informed consent. 2. Participant is physically healthy as confirmed by medical history, physical evaluation, ECG, and (in females) has a negative pregnancy test. 3. Two weeks free of anti-psychotic medication. Exclusion Criteria: All subjects with the following are excluded from study: 1. Clinically significant medical condition. 2. Prolonged QT-Interval ( \> 0.45 / \> 0.47 seconds for males/females). 3. Life history of bipolar disorder / schizophrenia / organic mental syndrome or intellectual disability. 4. Current major depressive disorder with a BDI score \> 32. 5. Current alcohol / drug use disorder of greater than mild severity. 6. Current suicidal ideation. 7. Allergy, or other contraindication, to Pimavanserin. 8. Current treatment with opiates or any agents that affect pain threshold. 9. Unwilling/unable to sign informed consent document.
Where this trial is running
Columbus, Ohio
- The Ohio State University College of Medicine — Columbus, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Emil F. Coccaro — Ohio State University
- Study coordinator: Matthew A. Timmins, PhD
- Email: matthew.timmins@osumc.edu
- Phone: 614-257-2119
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.