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New treatment option for Intermittent Explosive Disorder
Official title Pimavanserin and Aggression and Social Cognition.
ClinicalTrials.gov ID: NCT05895513
What this study is testing
What is Pimavanserin 34 mg?
Pimavanserin 34 mg is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for intermittent explosive disorder.
Also referred to as Nuplazid.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 to 55. Healthy volunteers may be eligible.
You may be able to join if
- Participants will have a current (or past) DSM-5 diagnosis of Intermittent Explosive Disorder (IED) or have a Life History of Aggression (LHA) score...
- Participant is between 21 and 55 years of age and is able to give informed consent.
- Participant is physically healthy as confirmed by medical history, physical evaluation, ECG, and (in females) has a negative pregnancy test.
- Two weeks free of anti-psychotic medication.
You likely can't join if
- All people with the following are excluded from study:
- Clinically significant medical condition.
- Prolonged QT-Interval ( \> 0.45 / \> 0.47 seconds for males/females).
- Life history of bipolar disorder / schizophrenia / organic mental syndrome or intellectual disability.
- Current major depressive disorder with a BDI score \> 32.
- Current alcohol / drug use disorder of greater than mild severity.
See the full eligibility 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...
- Participant is between 21 and 55 years of age and is able to give informed consent.
- Participant is physically healthy as confirmed by medical history, physical evaluation, ECG, and (in females) has a negative pregnancy test.
- Two weeks free of anti-psychotic medication.
- All people with the following are excluded from study:
- Clinically significant medical condition.
- Prolonged QT-Interval ( \> 0.45 / \> 0.47 seconds for males/females).
- Life history of bipolar disorder / schizophrenia / organic mental syndrome or intellectual disability.
- Current major depressive disorder with a BDI score \> 32.
- Current alcohol / drug use disorder of greater than mild severity.
- Current suicidal ideation.
- Allergy, or other contraindication, to Pimavanserin.
- Current treatment with opiates or any agents that affect pain threshold.
- Unwilling/unable to sign informed consent document.
The study team makes the final eligibility decision.
Where it's taking place
- Columbus, Ohio, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 21 years to 55 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Columbus, Ohio, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.