Pimavanserin and Aggression and Social Cognition.

• Status: Not yet recruiting
• Trial end date: 2025-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Ohio State University
• Collaborator: ACADIA Pharmaceuticals Inc.
• Treatments: Pimavanserin

Criteria

Inclusion Criteria:

Participants will have a current (or past) DSM-5 diagnosis of Intermittent Explosive Disorder (IED). 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. Four weeks free of psychotropic medication. (Please note that only 10% of screened subjects take psychotropics of any kind because we recruit from the general community and such individuals are much less likely to be under psychiatric care at the time of recruitment; we do not take patients off their medication to enroll them in studies; such patients are referred for clinical treatment instead).

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.