Pimavanserin and Aggression and Social Cognition.
Ohio State University · with ACADIA Pharmaceuticals Inc. · NCT05895513
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 21–55 · All sexes
- Healthy volunteers
- Accepted
- Study type
- Interventional · Phase 2
- Target enrollment
- 35
- US sites recruiting
- 1
- Study start
- August 1, 2024
- Record last updated
- March 27, 2025
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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.
Being studied: Pimavanserin 34 mg; Placebo
Conditions: Intermittent Explosive Disorder
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full 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:
- 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, ECG, and (in females) has a negative pregnancy test.
- Two weeks free of anti-psychotic medication.
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.
Recruiting US locations
The Ohio State University College of Medicine
Columbus, OH 43210
Study contacts (from the official record)
- Matthew A. Timmins, PhD · 614-257-2119 · matthew.timmins@osumc.edu
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