RecruitingPhase 2NCT05895513

Pimavanserin and Aggression and Social Cognition.

Effect of Pimavanserin on Aggression and Social Cognition.


Sponsor

Ohio State University

Enrollment

35 participants

Start Date

Aug 1, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 21 YearsMax Age: 55 Years

Inclusion Criteria4

  • 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 Criteria10

  • 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.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGPimavanserin 34 mg

5HT-2a receptor antagonist

DRUGPlacebo

Inactive Comparator


Locations(1)

The Ohio State University College of Medicine

Columbus, Ohio, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05895513


Related Trials