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5-HT2a receptor blocker
Pimavanserin for Aggression
Phase 2
Waitlist Available
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.
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ the tap will be done about five (5) hours after administration of pimavanserin and after placebo.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~the tap will be done about five (5) hours after administration of pimavanserin and after placebo.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Aggressive Responding on the Taylor Aggression Paradigm (TAP)
Secondary outcome measures
Social-Emotional Information Processing (Video-SEIP)
Side effects data
From 2019 Phase 3 trial • 392 Patients • NCT033255565%
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
2017
Completed Phase 3
~400
Find a Location
Who is running the clinical trial?
Ohio State UniversityLead Sponsor
829 Previous Clinical Trials
505,708 Total Patients Enrolled
3 Trials studying Intermittent Explosive Disorder
224 Patients Enrolled for Intermittent Explosive Disorder
ACADIA Pharmaceuticals Inc.Industry Sponsor
46 Previous Clinical Trials
10,905 Total Patients Enrolled
Emil F. CoccaroPrincipal InvestigatorOhio State University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 21 and 55 years old and can make my own medical decisions.I haven't taken any anti-psychotic medication for the last two weeks.I am not having thoughts of harming myself.I am physically healthy, have a normal heart test, and if female, not pregnant.I am currently experiencing severe depression.I am currently taking medication for pain that includes opiates.
Research Study Groups:
This trial has the following groups:- Group 1: Pimavanserin
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this clinical trial accept applicants of a youthful age?
"This clinical trial seeks out individuals aged 21-55 years old."
Answered by AI
To what extent does Pimavanserin present a hazard to patients?
"Although Phase 2 trials offer some indication of safety, Pimavanserin has yet to demonstrate efficacy in clinical studies — resulting in a score of 2."
Answered by AI
Who has the qualifications to take part in this clinical experiment?
"Individuals suffering from intermittent explosive disorder and aged between 21 to 55 can be eligible for this randomized trial, which has the capacity of enrolling 35 participants."
Answered by AI
Is enrollment for this scientific experiment still open?
"Clinicaltrials.gov indicates that this medical trial, which was first made available on July 1st 2023 and last updated May 31st 2023, is no longer recruiting participants. Nonetheless, there are other 70 clinical trials actively searching for patient volunteers at the moment."
Answered by AI
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