Pimavanserin and Aggression and Social Cognition. (NCT05895513)
Effect of Pimavanserin on Aggression and Social Cognition.
🩺 Plain-English Summary (8th-Grade Level)
The investigators are studying how certain drugs can reduce anger outbursts in people with anger problems. In this study the investigators seek to determine if a single 34 mg (two 17 mg tablets) oral dose of the 5-HT2a receptor blocker, pimavanserin, will reduce aggressive responding in individuals with impulsive aggression (Intermittent Explosive Disorder: IED) on a laboratory task that assesses aggression (Taylor Aggression Paradigm: TAP). We will also be examining how this drug impacts hostile social cognition e.g., hostile attribution). If pimvanserin reduces aggression in this study a next step would be a placebo-controlled treatment trial of pimavanserin in study participants with IED. Participation will first involve a remote (e.g., TEAMS) screening session. If potential study participants appear eligible they will come into the lab for an in-person session where participants will complete interviews and questionnaires and have a medical evaluation (including a physical exam, electrocardiogram, and screens for alcohol and drug use). During the next study session, participants will complete a diagnostic interview and a series of questionnaires, all of which can all take place on-line. During the next two sessions (which will be in-person) participants will undergo two (2) study sessions during which study participants will be given a study drug (orally). The drug given, pimavanserin, is currently available and is known to block serotonin receptors thought to be involved in regulating anger. After participants take the study drug, study participants will complete questionnaires and computer tasks for assessment of aggression and of hostile social cognition. Each of these two in-person study sessions will take at least eight (8) hours. A final on-line session will be done to make certain the investigators have all the data required by the study protocol.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (4 items) and avoid the listed exclusions (10 items).
Location: The Ohio State University College of Medicine — Columbus, Ohio
Age range: 21 Years to 55 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria: All subjects with the following are excluded from study:
- Clinically significant medical condition.
- Prolonged QT-Interval ( \> 0.45 / \> 0.47 seconds for males/females).
- Life history of bipolar disorder / schizophrenia / organic mental syndrome or intellectual disability.
- Current major depressive disorder with a BDI score \> 32.
- Current alcohol / drug use disorder of greater than mild severity.
- Current suicidal ideation.
- Allergy, or other contraindication, to Pimavanserin.
- Current treatment with opiates or any agents that affect pain threshold.
- Unwilling/unable to sign informed consent document.
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (1 Sites)
- The Ohio State University College of Medicine — Columbus, Ohio
📞 Contact the Study Coordinator
Phone: (614) 257-2119
Email: matthew.timmins@osumc.edu
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Intermittent Explosive Disorder
- Inflammatory Challenge in Human Aggression. — Columbus, Ohio
- Effect of Nitrous Oxide on Aggression. — Columbus, Ohio
Explore by condition: All Intermittent Explosive Disorder clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.