Intermittent Explosive DisorderPhase 2NCT05895513
Pimavanserin and Aggression and Social Cognition.
A Phase 2 study testing Pimavanserin 34 mg in people with Intermittent Explosive Disorder, run by Ohio State University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Intermittent Explosive Disorder
- What is being tested?
- Pimavanserin 34 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2024to Jan 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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:
- 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.
Who cannot join
- All subjects 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The Ohio State University College of Medicine
Columbus, Ohio, 43210
About this study
Official title: Effect of Pimavanserin on 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 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.
Read the detailed description
Human aggression is verbal and/or physical behavior directed at others (or objects) that results in injury to others (or objects). It is at the core of much human suffering and it is quite common. About four percent of the U.S. population have recurrent "anger attacks" and meet lifetime criteria for Intermittent Explosive Disorder (IED), a disorder of recurrent, problematic, impulsive aggression. In addition, another four percent of individuals have recurrent "anger attacks" that may not fully meet DSM-5 criteria for IED. Neurochemical brain studies have pointed to a modulatory role in human aggression for a variety of central neurotransmitters, particularly serotonin (5-HT). Evidence for a role for 5-HT in aggressive and suicidal behavior has been in the human literature since the late 1970s. Cerebrospinal fluid (CSF) levels of 5-HT metabolites (5-HIAA) have been reported as low in violent suicidal behavior and in those who have committed seriously aggressive acts such as homicide or attempted homicide. In addition, hormonal responses to 5-HT agonists are blunted in aggressive individuals and are inversely correlated with measures of aggression and suicidal behavior. Relevant to this proposal are data which report that the number of brain 5-HT-2a receptors are increased in those who had committed suicide by violent means and that brain and platelet 5-HT-2a receptors correlate in a positive direction with measures of aggression. In addition, similar findings have been reported regarding the PET neuroimaging of 5-HT-2a receptors in aggressive individuals. While stimulation of most 5-HT receptors increase behavioral inhibition, stimulation of 5-HT-2a receptors appear to do the opposite. If so, we hypothesize that blocking 5-HT-2a receptor activity with a 5-HT-2a receptor blocker will reduce aggressive responding in aggressive individuals. In this study, we propose to give a single dose of pimavanserin (and placebo on another day) and have aggressive individuals complete an analogue computer task of "aggressive responding". Because aggression is highly related to hostile social cognition, we will also have study participants complete a social cognition task to test the related hypothesis that pimavanserin can also reduce hostile social cognition. This project is designed to be an experimental medicine study to test the potential anti-aggressive efficacy of pimavanserin, a selective inverse agonist and antagonist of the serotonin 5-HT-2a receptor. As such, it is an early "proof of concept" study before, and without the expense of, conducting a clinical treatment trial.
Hypotheses of the study.
- Pre-treatment with pimavanserin, but not placebo, will reduce aggressive responding in the Taylor Aggression Paradigm (TAP) in human subjects. Reduced aggressive responding in the TAP would be reflected by the subjects selecting fewer numbers of "high" and "very high" electric shock levels in response to provocation to pre-programmed shock levels in the context of the TAP.
- Pre-treatment with Pimavanserin, but not placebo, will reduce hostile social cognition in aggressive individuals. Reduced hostile social cognition is reflected by an increase in the encoding of socially relevant information, a reduction in hostile attribution, and a reduction in negative emotional response while viewing brief (~ 10 seconds) video clips of socially ambiguous interactions between two people. The task involved is the Video-Social-Emotional Information Processing (V-SEIP) Task.
- Conditions
- Intermittent Explosive Disorder
- Being tested
- Pimavanserin 34 mg, Placebo
- Keywords
- Aggression, Intermittent Explosive Disorder, Hostile Social Cognition, 5-HT-2a Receptor Antagonist, Pimavanserin
- Medical subject headings
- Disruptive, Impulse Control, and Conduct Disorders, Aggression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pimavanserin 34 mgDrug
Also called Nuplazid
5HT-2a receptor antagonist
PlaceboDrug
Inactive Comparator
| Study group | Role | What they receive |
|---|---|---|
| Pimavanserin | Experimental | One single dose of pimavanserin (34 mg oral) Receives: Drug: Pimavanserin 34 mg |
| Placebo | Placebo comparator | One single dose of matching placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aggressive Responding on the Taylor Aggression Paradigm (TAP)
In the TAP, the subject competes against a fictitious opponent in a reaction time game during which the investigator manipulates provocation by having the "opponent" select increasing (mild) electric shock levels (i.e., a physically aggressive threat) which then elicits aggressive responding to the "confederate" when he/she loses a reaction-time task. Subjects can select shock from level 1 to level 9, and to select a "high" (10 level) or a "very high" (20 level) shock. The total number of "High" / "Very High" (10/20) shocks selected for the opponent is the outcome for heightened aggression in this study.
Measured: The TAP will be done about five (5) hours after administration of pimavanserin and after placebo.
Secondary outcomes (1)
Social-Emotional Information Processing (Video-SEIP)
The V-SEIP contains eight video stories presenting possible (i.e., socially ambiguous) aggressive encounters between "Actor A" (who the subject is told to identify with) and "Actor B" who physically, or verbally, assaults the "primary individual". After viewing each video story (~ 10 seconds), the subject is asked to record all the elements of the video they recall; this is referred to as encoding (ENC). Then, the subject rates the likelihood that "Actor B" acted towards "Actor A" because he/she wanted to physically/emotionally hurt the other person (Hostile Attribution: HA). Finally, the subject is asked to rate the likelihood of how angry/upset they would be if this "event" happened to them (Negative Emotional Response: NER).
Measured: The V-SEIP will be done about five (5) hours after administration of pimavanserin and after placebo.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2023
- Study start1 Aug 2024
- Primary completionJan 2027 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Intermittent Explosive DisorderStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Collaborators
- ACADIA Pharmaceuticals Inc.
- Responsible party
- Principal investigator, Emil Coccaro, Ohio State University
- Investigators
- Emil F. Coccaro, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05895513
- Sponsor's protocol ID
- 2023H0014
- Status last verified
- Mar 2025
- First submitted
- 18 May 2023
- Last updated
- 27 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Asberg M, Traskman L, Thoren P. 5-HIAA in the cerebrospinal fluid. A biochemical suicide predictor? Arch Gen Psychiatry. 1976 Oct;33(10):1193-7. doi: 10.1001/archpsyc.1976.01770100055005.
PubMed 971028Berman ME, McCloskey MS, Fanning JR, Schumacher JA, Coccaro EF. Serotonin augmentation reduces response to attack in aggressive individuals. Psychol Sci. 2009 Jun;20(6):714-20. doi: 10.1111/j.1467-9280.2009.02355.x. Epub 2009 May 5.
PubMed 19422623Brown GL, Ebert MH, Goyer PF, Jimerson DC, Klein WJ, Bunney WE, Goodwin FK. Aggression, suicide, and serotonin: relationships to CSF amine metabolites. Am J Psychiatry. 1982 Jun;139(6):741-6. doi: 10.1176/ajp.139.6.741.
PubMed 6177256Coccaro EF. Intermittent explosive disorder as a disorder of impulsive aggression for DSM-5. Am J Psychiatry. 2012 Jun;169(6):577-88. doi: 10.1176/appi.ajp.2012.11081259.
PubMed 22535310Coccaro EF, Lee RJ. Disordered Aggression and Violence in the United States. J Clin Psychiatry. 2020 Mar 17;81(2):19m12937. doi: 10.4088/JCP.19m12937.
PubMed 32220154Coccaro EF, Fanning JR, Fisher E, Couture L, Lee RJ. Social emotional information processing in adults: Development and psychometrics of a computerized video assessment in healthy controls and aggressive individuals. Psychiatry Res. 2017 Feb;248:40-47. doi: 10.1016/j.psychres.2016.11.004. Epub 2016 Nov 8.
PubMed 28012305Coccaro EF, Fanning JR, Keedy SK, Lee RJ. Social cognition in Intermittent Explosive Disorder and aggression. J Psychiatr Res. 2016 Dec;83:140-150. doi: 10.1016/j.jpsychires.2016.07.010. Epub 2016 Jul 16.
PubMed 27621104Coccaro EF, Kavoussi RJ, Sheline YI, Berman ME, Csernansky JG. Impulsive aggression in personality disorder correlates with platelet 5-HT2A receptor binding. Neuropsychopharmacology. 1997 Mar;16(3):211-6. doi: 10.1016/S0893-133X(96)00194-7.
PubMed 9138437Coccaro EF, Lee R, Kavoussi RJ. Aggression, suicidality, and intermittent explosive disorder: serotonergic correlates in personality disorder and healthy control subjects. Neuropsychopharmacology. 2010 Jan;35(2):435-44. doi: 10.1038/npp.2009.148.
PubMed 19776731Coccaro EF, Lee RJ, Kavoussi RJ. A double-blind, randomized, placebo-controlled trial of fluoxetine in patients with intermittent explosive disorder. J Clin Psychiatry. 2009 Apr 21;70(5):653-62. doi: 10.4088/JCP.08m04150.
PubMed 19389333Coccaro EF, Noblett KL, McCloskey MS. Attributional and emotional responses to socially ambiguous cues: validation of a new assessment of social/emotional information processing in healthy adults and impulsive aggressive patients. J Psychiatr Res. 2009 Jul;43(10):915-25. doi: 10.1016/j.jpsychires.2009.01.012. Epub 2009 Apr 3.
PubMed 19345371Coccaro EF, Siever LJ, Klar HM, Maurer G, Cochrane K, Cooper TB, Mohs RC, Davis KL. Serotonergic studies in patients with affective and personality disorders. Correlates with suicidal and impulsive aggressive behavior. Arch Gen Psychiatry. 1989 Jul;46(7):587-99. doi: 10.1001/archpsyc.1989.01810070013002.
PubMed 2735812Lee R, Coccaro, E.F. Neurotransmitters and Intermittent Explosive Disorder. In: Intermittent Explosive Disorder, EF Coccaro and MS McCloskey (eds). 2019:87-110.
Linnoila M, Virkkunen M, Scheinin M, Nuutila A, Rimon R, Goodwin FK. Low cerebrospinal fluid 5-hydroxyindoleacetic acid concentration differentiates impulsive from nonimpulsive violent behavior. Life Sci. 1983 Dec 26;33(26):2609-14. doi: 10.1016/0024-3205(83)90344-2.
PubMed 6198573McCloskey MS, Berman ME. Laboratory measures of aggression: The Taylor Aggression Paradigm. In: EF C, ed. Aggression: Psychiatric Assessment and Treatment. Marcel Dekker; 2003:397.
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Pimavanserin on Aggression and Social Cognition.
- ClinicalTrials.gov ID
- NCT05895513
- Acronym / sponsor ID
- 2023H0014
- Conditions
- Intermittent Explosive Disorder
- Keywords
- Aggression, Intermittent Explosive Disorder, Hostile Social Cognition, 5-HT-2a Receptor Antagonist, Pimavanserin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Collaborators
- ACADIA Pharmaceuticals Inc.
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 8 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Human aggression is verbal and/or physical behavior directed at others (or objects) that results in injury to others (or objects). It is at the core of much human suffering and it is quite common. About four percent of the U.S. population have recurrent "anger attacks" and meet lifetime criteria for Intermittent Explosive Disorder (IED), a disorder of recurrent, problematic, impulsive aggression. In addition, another four percent of individuals have recurrent "anger attacks" that may not fully meet DSM-5 criteria for IED. Neurochemical brain studies have pointed to a modulatory role in human aggression for a variety of central neurotransmitters, particularly serotonin (5-HT). Evidence for a role for 5-HT in aggressive and suicidal behavior has been in the human literature since the late 1970s. Cerebrospinal fluid (CSF) levels of 5-HT metabolites (5-HIAA) have been reported as low in violent suicidal behavior and in those who have committed seriously aggressive acts such as homicide or attempted homicide. In addition, hormonal responses to 5-HT agonists are blunted in aggressive individuals and are inversely correlated with measures of aggression and suicidal behavior. Relevant to this proposal are data which report that the number of brain 5-HT-2a receptors are increased in those who had committed suicide by violent means and that brain and platelet 5-HT-2a receptors correlate in a positive direction with measures of aggression. In addition, similar findings have been reported regarding the PET neuroimaging of 5-HT-2a receptors in aggressive individuals. While stimulation of most 5-HT receptors increase behavioral inhibition, stimulation of 5-HT-2a receptors appear to do the opposite. If so, we hypothesize that blocking 5-HT-2a receptor activity with a 5-HT-2a receptor blocker will reduce aggressive responding in aggressive individuals. In this study, we propose to give a single dose of pimavanserin (and placebo on another day) and have aggressive individuals complete an analogue computer task of "aggressive responding". Because aggression is highly related to hostile social cognition, we will also have study participants complete a social cognition task to test the related hypothesis that pimavanserin can also reduce hostile social cognition. This project is designed to be an experimental medicine study to test the potential anti-aggressive efficacy of pimavanserin, a selective inverse agonist and antagonist of the serotonin 5-HT-2a receptor. As such, it is an early "proof of concept" study before, and without the expense of, conducting a clinical treatment trial.
Hypotheses of the study.
- Pre-treatment with pimavanserin, but not placebo, will reduce aggressive responding in the Taylor Aggression Paradigm (TAP) in human subjects. Reduced aggressive responding in the TAP would be reflected by the subjects selecting fewer numbers of "high" and "very high" electric shock levels in response to provocation to pre-programmed shock levels in the context of the TAP.
- Pre-treatment with Pimavanserin, but not placebo, will reduce hostile social cognition in aggressive individuals. Reduced hostile social cognition is reflected by an increase in the encoding of socially relevant information, a reduction in hostile attribution, and a reduction in negative emotional response while viewing brief (~ 10 seconds) video clips of socially ambiguous interactions between two people. The task involved is the Video-Social-Emotional Information Processing (V-SEIP) Task.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pimavanserin | Experimental | Drug: Pimavanserin 34 mgOne single dose of pimavanserin (34 mg oral) |
| Placebo | Placebo comparator | Drug: PlaceboOne single dose of matching placebo |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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:
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pimavanserin 34 mgAlso: Nuplazid5HT-2a receptor antagonist | Drug | Pimavanserin |
| PlaceboInactive Comparator | Drug | Placebo |
Primary outcome
Aggressive Responding on the Taylor Aggression Paradigm (TAP)
Time frame: The TAP will be done about five (5) hours after administration of pimavanserin and after placebo.
In the TAP, the subject competes against a fictitious opponent in a reaction time game during which the investigator manipulates provocation by having the "opponent" select increasing (mild) electric shock levels (i.e., a physically aggressive threat) which then elicits aggressive responding to the "confederate" when he/she loses a reaction-time task. Subjects can select shock from level 1 to level 9, and to select a "high" (10 level) or a "very high" (20 level) shock. The total number of "High" / "Very High" (10/20) shocks selected for the opponent is the outcome for heightened aggression in this study.
1 secondary outcome
Social-Emotional Information Processing (Video-SEIP)
Time frame: The V-SEIP will be done about five (5) hours after administration of pimavanserin and after placebo.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2025.
- Background: PubMed 971028Asberg M, Traskman L, Thoren P. 5-HIAA in the cerebrospinal fluid. A biochemical suicide predictor? Arch Gen Psychiatry. 1976 Oct;33(10):1193-7. doi: 10.1001/archpsyc.1976.01770100055005.
- Background: PubMed 19422623Berman ME, McCloskey MS, Fanning JR, Schumacher JA, Coccaro EF. Serotonin augmentation reduces response to attack in aggressive individuals. Psychol Sci. 2009 Jun;20(6):714-20. doi: 10.1111/j.1467-9280.2009.02355.x. Epub 2009 May 5.
- Background: PubMed 6177256Brown GL, Ebert MH, Goyer PF, Jimerson DC, Klein WJ, Bunney WE, Goodwin FK. Aggression, suicide, and serotonin: relationships to CSF amine metabolites. Am J Psychiatry. 1982 Jun;139(6):741-6. doi: 10.1176/ajp.139.6.741.
- Background: PubMed 22535310Coccaro EF. Intermittent explosive disorder as a disorder of impulsive aggression for DSM-5. Am J Psychiatry. 2012 Jun;169(6):577-88. doi: 10.1176/appi.ajp.2012.11081259.
- Background: PubMed 32220154Coccaro EF, Lee RJ. Disordered Aggression and Violence in the United States. J Clin Psychiatry. 2020 Mar 17;81(2):19m12937. doi: 10.4088/JCP.19m12937.
- Background: PubMed 28012305Coccaro EF, Fanning JR, Fisher E, Couture L, Lee RJ. Social emotional information processing in adults: Development and psychometrics of a computerized video assessment in healthy controls and aggressive individuals. Psychiatry Res. 2017 Feb;248:40-47. doi: 10.1016/j.psychres.2016.11.004. Epub 2016 Nov 8.
- Background: PubMed 27621104Coccaro EF, Fanning JR, Keedy SK, Lee RJ. Social cognition in Intermittent Explosive Disorder and aggression. J Psychiatr Res. 2016 Dec;83:140-150. doi: 10.1016/j.jpsychires.2016.07.010. Epub 2016 Jul 16.
- Background: PubMed 9138437Coccaro EF, Kavoussi RJ, Sheline YI, Berman ME, Csernansky JG. Impulsive aggression in personality disorder correlates with platelet 5-HT2A receptor binding. Neuropsychopharmacology. 1997 Mar;16(3):211-6. doi: 10.1016/S0893-133X(96)00194-7.
- Background: PubMed 19776731Coccaro EF, Lee R, Kavoussi RJ. Aggression, suicidality, and intermittent explosive disorder: serotonergic correlates in personality disorder and healthy control subjects. Neuropsychopharmacology. 2010 Jan;35(2):435-44. doi: 10.1038/npp.2009.148.
- Background: PubMed 19389333Coccaro EF, Lee RJ, Kavoussi RJ. A double-blind, randomized, placebo-controlled trial of fluoxetine in patients with intermittent explosive disorder. J Clin Psychiatry. 2009 Apr 21;70(5):653-62. doi: 10.4088/JCP.08m04150.
- Background: PubMed 19345371Coccaro EF, Noblett KL, McCloskey MS. Attributional and emotional responses to socially ambiguous cues: validation of a new assessment of social/emotional information processing in healthy adults and impulsive aggressive patients. J Psychiatr Res. 2009 Jul;43(10):915-25. doi: 10.1016/j.jpsychires.2009.01.012. Epub 2009 Apr 3.
- Background: PubMed 2735812Coccaro EF, Siever LJ, Klar HM, Maurer G, Cochrane K, Cooper TB, Mohs RC, Davis KL. Serotonergic studies in patients with affective and personality disorders. Correlates with suicidal and impulsive aggressive behavior. Arch Gen Psychiatry. 1989 Jul;46(7):587-99. doi: 10.1001/archpsyc.1989.01810070013002.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Emil F. Coccaro principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pimavanserin 34 mg in people with Intermittent Explosive Disorder, run by Ohio State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Matthew A. Timmins, PhD (614-257-2119, matthew.timmins@osumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aggressive Responding on the Taylor Aggression Paradigm (TAP) (time frame: The TAP will be done about five (5) hours after administration of pimavanserin and after placebo.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05895513, which also lists 20 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2025.