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5-HT2a receptor blocker

Pimavanserin for Aggression

Phase 2
Recruiting
Led By Emil F. Coccaro
Research Sponsored by Ohio State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up the tap will be done about five (5) hours after administration of pimavanserin and after placebo.

Summary

This trial is testing if a drug (pimavanserin) can reduce aggression in people with anger problems. Participants will do remote & in-person sessions, take the drug, & do questionnaires & computer tasks.

Who is the study for?
This trial is for adults aged 21-55 with impulsive aggression or Intermittent Explosive Disorder. They must be in good physical health, not on psychotropic meds for the last four weeks, and able to consent. Women must test negative for pregnancy.
What is being tested?
The study tests if a single dose of Pimavanserin (34 mg), which blocks certain serotonin receptors, can reduce aggressive behavior and alter hostile social cognition in people with anger issues compared to a placebo.
What are the potential side effects?
While specific side effects are not listed here, Pimavanserin generally may cause symptoms like nausea, constipation, and potential heart rhythm changes as it interacts with brain chemistry.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~the tap will be done about five (5) hours after administration of pimavanserin and after placebo.
This trial's timeline: 3 weeks for screening, Varies for treatment, and the tap will be done about five (5) hours after administration of pimavanserin and after placebo. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Aggressive Responding on the Taylor Aggression Paradigm (TAP)
Secondary study objectives
Social-Emotional Information Processing (Video-SEIP)

Side effects data

From 2019 Phase 3 trial • 392 Patients • NCT03325556
5%
Urinary tract infection
2%
Headache
1%
Dehydration
1%
Fall
100%
80%
60%
40%
20%
0%
Study treatment Arm
Pimavanserin Open-Label Period
Placebo Double-Blind Period
Pimavanserin Double-Blind Period

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: PimavanserinExperimental Treatment1 Intervention
One single dose of pimavanserin (34 mg oral)
Group II: PlaceboPlacebo Group1 Intervention
One single dose of matching placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pimavanserin 34 mg
2024
Completed Phase 3
~430

Find a Location

Who is running the clinical trial?

Ohio State UniversityLead Sponsor
866 Previous Clinical Trials
655,089 Total Patients Enrolled
4 Trials studying Intermittent Explosive Disorder
336 Patients Enrolled for Intermittent Explosive Disorder
ACADIA Pharmaceuticals Inc.Industry Sponsor
47 Previous Clinical Trials
11,560 Total Patients Enrolled
Emil F. CoccaroPrincipal InvestigatorOhio State University

Media Library

Pimavanserin (5-HT2a receptor blocker) Clinical Trial Eligibility Overview. Trial Name: NCT05895513 — Phase 2
Intermittent Explosive Disorder Research Study Groups: Pimavanserin, Placebo
Intermittent Explosive Disorder Clinical Trial 2023: Pimavanserin Highlights & Side Effects. Trial Name: NCT05895513 — Phase 2
Pimavanserin (5-HT2a receptor blocker) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05895513 — Phase 2
~23 spots leftby Jan 2026
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