Using Pimavanserin to Reduce Aggression in Intermittent Explosive Disorder

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the effects of a single oral dose of 34 mg of pimavanserin, a 5-HT2a receptor antagonist, on reducing aggressive behavior in individuals diagnosed with Intermittent Explosive Disorder (IED). Participants will undergo a remote screening followed by an in-person session where they will complete interviews, questionnaires, and medical evaluations. The study aims to assess aggression levels using the Taylor Aggression Paradigm and examine the drug's impact on hostile social cognition. If successful, a subsequent placebo-controlled trial may follow.

Why it matters

Who can join: the full rules

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.

Where it's running

• The Ohio State University College of Medicine
  Columbus, Ohio, United States Recruiting

Study contacts

• Principal investigator: Emil F. Coccaro — Ohio State University
• Study coordinator: Matthew A. Timmins, PhD
• Email: matthew.timmins@osumc.edu
• Phone: 614-257-2119

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.