Recruiting
Phase 2

Pimavanserin

Sponsor:

Ohio State University

Code:

NCT05895513

Conditions

Intermittent Explosive Disorder

Eligibility Criteria

Sex: All

Age: 21 - 55

Healthy Volunteers: Accepted

Interventions

Pimavanserin 34 mg

Placebo

Study Details

Brief 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.

Conditions

Intermittent Explosive Disorder

Study ID

NCT05895513

Start date

Aug 1, 2024

Status verified date

Mar, 2025

Completion date

Jan, 2028

Anticipated

Primary completion date

Jan, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 55

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

35 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Pimavanserin

One single dose of pimavanserin (34 mg oral)

placebo comparator: Placebo

One single dose of matching placebo

Interventions

Pimavanserin 34 mg

5HT-2a receptor antagonist

Placebo

Inactive Comparator

Primary outcome measure

  • Aggressive Responding on the Taylor Aggression Paradigm (TAP) [ Time Frame: The TAP will be done about five (5) hours after administration of pimavanserin and after placebo. ]

Central Contacts and Locations

Central contacts

Locations

The Ohio State University College of Medicine

Recruiting

Columbus, Ohio, United States, 43210

More Information

Sponsor

Ohio State University

Last update posted

Mar 27, 2025

Last verified

Mar, 2025

Keywords

  • Aggression
  • Intermittent Explosive Disorder
  • Hostile Social Cognition
  • 5-HT-2a Receptor Antagonist
  • Pimavanserin

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ohio State University on 2025-03-27.