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NCT05895513 · ClinicalTrials.gov registry record · Phase 2
Pimavanserin and Aggression and Social Cognition.
A Phase 2 study of Intermittent Explosive Disorder, sponsored by Ohio State University.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 35
- Enrollment target
- 1
- Study location
NCT05895513 is a Phase 2 study of Intermittent Explosive Disorder that is actively recruiting participants, run by Ohio State University. The registered enrollment target is 35 participants, below the 95-participant average among 3 other Intermittent Explosive Disorder trials with a reported enrollment target (63% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05895513, a Phase 2 study of Intermittent Explosive Disorder, is actively recruiting participants, sponsored by Ohio State University.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 35 participants
- Enrollment target
- 1
- Study location
Study Summary
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 complete interviews and questionnaires and have a medical evaluation (including a physical exam, electrocardiogram, and screens for alcohol and drug use). During the next study session, participants will complete a diagnostic interview and a series of questionnaires, all of which can all take place on-line. During the next two sessions (which will be in-person) participants will undergo two (2) study sessions during which study participants will be given a study drug (orally). The drug given, pimavanserin, is currently available and is known to block serotonin receptors thought to be involved in regulating anger. After participants take the study drug, study participants will complete questionnaires and computer tasks for assessment of aggression and of hostile social cognition. Each of these two in-person study sessions will take at least eight (8) hours. A final on-line session will be done to make certain the investigators have all the data required by the study protocol.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Pimavanserin 34 mg
Study Locations (1)
Ohio
- The Ohio State University College of Medicine - Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2024-08-01 |
| Est. Completion | 2028-01 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05895513
The ClinicalTrials.gov registry entry for NCT05895513 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 35 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 95-participant average among 3 other Intermittent Explosive Disorder trials with a reported enrollment target (63% lower). The listed sponsor is Ohio State University, which has 552 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Intermittent Explosive Disorder appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05895513 reports 1 study location spanning 1 distinct geographic area - top geographies include Ohio.
Frequently Asked Questions
What is clinical trial NCT05895513 about?
NCT05895513 is a clinical study titled "Pimavanserin and Aggression and Social Cognition.". 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 ...
What is the current status of trial NCT05895513?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 35 participants. The study started on 2024-08-01. Estimated completion is 2028-01.
What conditions does trial NCT05895513 study?
This clinical trial studies the following conditions: Intermittent Explosive Disorder.
What interventions are being tested in trial NCT05895513?
The interventions under investigation include: Placebo (DRUG), Pimavanserin 34 mg (DRUG).
Who is sponsoring clinical trial NCT05895513?
This trial is sponsored by Ohio State University, which has 552 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05895513 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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