RECRUITING

Pimavanserin and Aggression and Social Cognition.

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Effect of Pimavanserin on Aggression and Social Cognition.

Quick Facts

Study Start:2024-08-01
Study Completion:2026-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05895513

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years to 55 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Participant is between 21 and 55 years of age and is able to give informed consent.
  2. 2. Participant is physically healthy as confirmed by medical history, physical evaluation, ECG, and (in females) has a negative pregnancy test.
  3. 3. Two weeks free of anti-psychotic medication.
  1. 1. Clinically significant medical condition.
  2. 2. Prolonged QT-Interval ( \> 0.45 / \> 0.47 seconds for males/females).
  3. 3. Life history of bipolar disorder / schizophrenia / organic mental syndrome or intellectual disability.
  4. 4. Current major depressive disorder with a BDI score \> 32.
  5. 5. Current alcohol / drug use disorder of greater than mild severity.
  6. 6. Current suicidal ideation.
  7. 7. Allergy, or other contraindication, to pimavanserin.
  8. 8. Current treatment with opiates or any agents that affect pain threshold.
  9. 9. Unwilling/unable to sign informed consent document.

Contacts and Locations

Study Contact

Matthew A. Timmins, PhD
CONTACT
614-257-2119
matthew.timmins@osumc.edu

Principal Investigator

Emil F. Coccaro
PRINCIPAL_INVESTIGATOR
Ohio State University

Study Locations (Sites)

The Ohio State University College of Medicine
Columbus, Ohio, 43210
United States

Collaborators and Investigators

Sponsor: Ohio State University

  • Emil F. Coccaro, PRINCIPAL_INVESTIGATOR, Ohio State University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-08-01
Study Completion Date2026-01

Study Record Updates

Study Start Date2024-08-01
Study Completion Date2026-01

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Intermittent Explosive Disorder