Actively Recruiting

Phase 2
Age: 21Years - 55Years
All Genders
Healthy Volunteers
NCT05895513

Pimavanserin and Aggression and Social Cognition.

Led by Ohio State University · Updated on 2025-03-27

35

Participants Needed

1

Research Sites

178 weeks

Total Duration

On this page

Sponsors

O

Ohio State University

Lead Sponsor

A

ACADIA Pharmaceuticals Inc.

Collaborating Sponsor

AI-Summary

What this Trial 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.

CONDITIONS

Official Title

Pimavanserin and Aggression and Social Cognition.

Who Can Participate

Age: 21Years - 55Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Participants must have a current or past DSM-5 diagnosis of Intermittent Explosive Disorder (IED) or a Life History of Aggression score of 12 or higher
  • Age between 21 and 55 years and able to give informed consent
  • Physically healthy as confirmed by medical history, physical exam, ECG, and for females, a negative pregnancy test
  • Free of antipsychotic medication for at least two weeks
Not Eligible

You will not qualify if you...

  • Clinically significant medical condition
  • Prolonged QT-Interval (>0.45 seconds for males, >0.47 seconds for females)
  • History of bipolar disorder, schizophrenia, organic mental syndrome, or intellectual disability
  • Current major depressive disorder with a Beck Depression Inventory score over 32
  • Current alcohol or drug use disorder of greater than mild severity
  • Current suicidal ideation
  • Allergy or contraindication to pimavanserin
  • Current treatment with opiates or any medication affecting pain threshold
  • Unwilling or unable to sign informed consent

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

The Ohio State University College of Medicine

Columbus, Ohio, United States, 43210

Actively Recruiting

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Research Team

M

Matthew A. Timmins, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

BASIC_SCIENCE

Number of Arms

2

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