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Pimavanserin and Aggression and Social Cognition.

RecruitingPhase 2Ages 21 Years - 55 YearsAllOhio State University
NCT05895513 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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.
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What it tests

  • Pimavanserin 34 mg
  • Placebo
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Where

1 site
The Ohio State University College of Medicine
Columbus, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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