Attention Deficit Hyperactivity Disorder (ADHD)Phase 2NCT03638466

Exploratory fMRI Study on the Treatment for Impulsive Aggression in Children With ADHD

A Phase 2 study testing Functional Magnetic Resonance Imaging (fMRI), Magnetic Resonance Spectroscopy (MRS) and Point Subtraction Aggression Paradigm (PSAP) Task in people with Attention Deficit Hyperactivity Disorder (ADHD) and Impulsive Aggression, run by Supernus Pharmaceuticals, Inc. at 3 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 8 to 12 years
Conditions the study is for: Attention Deficit Hyperactivity Disorder (ADHD), Impulsive Aggression
What is being tested?: Functional Magnetic Resonance Imaging (fMRI), Magnetic Resonance Spectroscopy (MRS) and Point Subtraction Aggression Paradigm (PSAP) Task
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 7 participants
Where: 3 sitesUnited States
Study dates: 30 May 2019to 7 Nov 2019
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 8 to 12 years
All sexes
No healthy volunteers
Child

Who may be able to join

Otherwise healthy male or female subjects, aged 8-12 years, inclusive, at the time of screening with primary diagnosis of ADHD and currently receiving monotherapy treatment with an optimized US Food and Drug Administration (FDA)-approved ADHD medication.
Impulsive aggression (IA) confirmed at screening using the R-MOAS and the Vitiello Aggression Scale.

Who cannot join

Current or lifetime diagnosis of epilepsy, major depressive disorder, bipolar disorder, schizophrenia or related disorder, personality disorder, Tourette's disorder, fetal alcohol syndrome, or psychosis not otherwise specified.
Currently meeting DSM criteria for autism spectrum disorder, pervasive developmental disorder, obsessive-compulsive disorder, post-traumatic stress disorder.
Known or suspected IQ <70, pregnancy, substance or alcohol abuse.
Known history of implanted brain stimulator, vagal nerve stimulator, ventriculoperitoneal shunt, cardiac pacemaker, orthodontic braces, or implanted medication port. Visual and hearing (≥25 dB) impairment.
Pre-existing medical or psychological conditions that preclude being in the MRI scanner (e.g., claustrophobia, morbid obesity, or marked anxiety about the procedure).

Trial locations and contacts

3 sites in 1 country.

United States3 sites

Meridien Research aka Florida Clinical Research Center, LLC
Lakeland, Florida, 33805
Florida Clinical Research Center, LLC.
Maitland, Florida, 32751
University of South Florida- Dept. of Psychiatry and Neurosciences
Tampa, Florida, 33613

Other trials in United States

About this study

Official title: Exploratory Neuroimaging Study to Evaluate the Effect on Brain Activity of SPN-810 for Impulsive Aggression (IA) in Patients With Attention-Deficit/Hyperactivity Disorder (ADHD) in Conjunction With Standard ADHD Treatment

The purpose of this study was to evaluate the effect of 4-week SPN-810 treatment on brain functioning in patients aged 8-12 years with ADHD and associated feature of impulsive aggression (IA). This was achieved using functional magnetic resonance imaging (fMRI) in conjunction with the point subtraction aggression paradigm (PSAP) Task, a behavioral aggression paradigm in which subjects are provoked by having money indirectly taken from them by a fictitious opponent, simulating an aggression response.

Read the detailed description

Approximately 30 subjects aged 8-12 diagnosed with ADHD and associated feature of IA were recruited in this study. The PSAP is a behavioral aggression test used to evaluate behavioral response related to impulsive aggression. The task was combined with functional MRI to evaluate the change in brain activity measured as BOLD signal (blood oxygenation level-dependent) from baseline to the end of the treatment with SPN-810.

The level of neurotransmitters Glutamate and GABA were also measured using magnetic resonance spectroscopy (MRS).

Additionally, the improvement and severity in impulsive aggression behaviors were assessed using validated scales.

Conditions: Attention Deficit Hyperactivity Disorder (ADHD), Impulsive Aggression
Being tested: Functional Magnetic Resonance Imaging (fMRI), Magnetic Resonance Spectroscopy (MRS), Point Subtraction Aggression Paradigm (PSAP) Task, SPN-810, Placebo
Medical subject headings: Attention Deficit Disorder with Hyperactivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Functional Magnetic Resonance Imaging (fMRI)Diagnostic test
Neural brain activity measured by fMRI
Magnetic Resonance Spectroscopy (MRS)Diagnostic test
Glutamate and GABA levels measured by MRS
Point Subtraction Aggression Paradigm (PSAP) TaskBehavioural
Aggression score measured by the PSAP task
SPN-810Drug
Treatment of SPN-810 (36 mg) on neuronal brain activity, GABA and Glutamate levels and on the aggression score
PlaceboDrug
Treatment of placebo on neuronal brain activity, GABA and Glutamate levels and on the aggression score

Study groups in NCT03638466
Study group	Role	What they receive
High dose SPN-810 (36 mg)	Active comparator	Subjects were randomized to receive SPN-810 18 mg twice a day twice each day with and without food, in addition to the stable dose of the optimized ADHD medication. Receives: Diagnostic Test: Functional Magnetic Resonance Imaging (fMRI); Diagnostic Test: Magnetic Resonance Spectroscopy (MRS); Behavioral: Point Subtraction Aggression Paradigm (PSAP) Task; Drug: SPN-810
Placebo	Placebo comparator	Subjects were randomized to receive Placebo twice a day twice each day with and without food, in addition to the stable dose of the optimized ADHD medication. Receives: Diagnostic Test: Functional Magnetic Resonance Imaging (fMRI); Diagnostic Test: Magnetic Resonance Spectroscopy (MRS); Behavioral: Point Subtraction Aggression Paradigm (PSAP) Task; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Aggression-related Change in the Whole Brain in BOLD (Blood Oxygenation Level-dependent) Signal fMRI Contrast in Response to the PSAP Task
The primary endpoint was the aggression-related change in the whole brain in BOLD signal fMRI contrast in response to the PSAP task. BOLD fMRI contrast (neural activation) investigates brain activity by measuring the change in blood oxygenation. Change in brain activity was measured by a change in BOLD response in brain regions during the aggressive response relative to the monetary response, where the aggression was defined as the number of Option 2 presses (aggressive response) divided by the total number of button presses and the number of provocations. Change of aggression-related MRI signal was acquired at baseline and 4 weeks after SPN-810 treatment. A positive number represents an increase in activity. Region of interest is described by the location of the peak value and described by Montreal Neurological Institute (MNI) X, Y, Z coordinates. Data represent the post-treatment minus baseline change in BOLD contrast Aggressive Response> Monetary Response.
Measured: Baseline/Visit 2 (Day -5) to Visit 5 (Day 28) for a total of 4 weeks.
Provocation Event - Related Change in the Whole Brain in BOLD Signal fMRI Contrast in Response to the PSAP Task
BOLD (blood oxygenation level-dependent) fMRI contrast (neural activation) investigates brain activity by measuring the change in blood oxygenation. It was collected during the PSAP behavioral task while playing the game: the participants play a computer game in which they can steal points (simulating an aggressive behavior) or have points stolen by the opponent (provocation event) by pressing Option 1, 2 or 3 on a keypad a set number of times to achieve a specific outcome. A positive number represents an increase in activity. The region of interest is described by the location of the peak value within that cluster and described by Montreal Neurological Institute (MNI) X, Y, and Z coordinates. Data represent the post-treatment minus baseline change in BOLD contrast Provocation Event >Monetary Response.
Measured: Baseline/Visit 2 (Day -5) to Visit 5 (Day 28) for a total of 4 weeks.
Effect of SPN-810 on the Aggressions Score
The Point Subtraction Aggression Paradigm (PSAP) is a behavioral aggression paradigm consisting of a computer game in which each participant plays against a computer to earn points. The subject can steal points (i.e., aggressive behavior) or have points stolen by the opponent (i.e., provocation). The subject can press 1 of 3 buttons on a keypad a set number of times. By pressing the button for Option 1, 100 times, the subject will earn a point; pressing the button for Option 2, 20 consecutive times is the "aggression" action that results in stealing a point from the opponent; pressing Option 3, 20 times protects the subject from the opponent's attempt to steal points (i.e., money). The aggression score is averaged across two sessions and calculated as the number of Option 2 button presses divided by the sum of total button presses and the number of provocation events received, with a range minimum = 1, maximum = 143. The higher scores reflect increased aggression.
Measured: Baseline/Visit 2 (Day -5) to Visit 5 (Day 28) for a total of 4 weeks.

Secondary outcomes (1)

Effect of SPN-810 on GABA and Glutamate Levels Using Magnetic Resonance Spectroscopy (MRS)
GABA and Glutamate concentrations (mM) were measured in the anterior cingulate cortex using magnetic resonance spectroscopy (MRS). Data represent the change from Baseline (Visit 2) to Visit 5.
Measured: Baseline/Visit 2 (Day -5) to Visit 5 (Day 28) for a total of 4 weeks.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 May 20197 Nov 2019

First posted20 Aug 2018
Study start30 May 2019
Primary completion7 Nov 2019
Study completion7 Nov 2019

Why it stopped: Financial decision

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Attention Deficit Hyperactivity Disorder (ADHD)Studies of the same condition, open and under way.
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
Model description: A multi-center, double-blind, randomized (1:1), placebo-controlled, parallel-group, 2-arm study
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 7 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03638466
Sponsor's protocol ID: 810P204
Status last verified: Feb 2025
First submitted: 16 Aug 2018
Last updated: 2 May 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

Cherek DR, Moeller FG, Schnapp W, Dougherty DM. Studies of violent and nonviolent male parolees: I. Laboratory and psychometric measurements of aggression. Biol Psychiatry. 1997 Mar 1;41(5):514-22. doi: 10.1016/s0006-3223(96)00059-5.
PubMed 9046983
Bubenzer-Busch S, Herpertz-Dahlmann B, Kuzmanovic B, Gaber TJ, Helmbold K, Ullisch MG, Baurmann D, Eickhoff SB, Fink GR, Zepf FD. Neural correlates of reactive aggression in children with attention-deficit/hyperactivity disorder and comorbid disruptive behaviour disorders. Acta Psychiatr Scand. 2016 Apr;133(4):310-23. doi: 10.1111/acps.12475. Epub 2015 Aug 21.
PubMed 26292852

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 2 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Exploratory Neuroimaging Study to Evaluate the Effect on Brain Activity of SPN-810 for Impulsive Aggression (IA) in Patients With Attention-Deficit/Hyperactivity Disorder (ADHD) in Conjunction With Standard ADHD Treatment
ClinicalTrials.gov ID: NCT03638466
Acronym / sponsor ID: 810P204
Conditions: Attention Deficit Hyperactivity Disorder (ADHD), Impulsive Aggression
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Financial decision
Enrolment: 7 participants (actual)
Lead sponsor: Supernus Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
Study start: 30 May 2019 (actual)
Primary completion: 7 Nov 2019 (actual)
Study completion: 7 Nov 2019 (actual)
First posted: 20 Aug 2018 (actual)
Results: Posted 2 May 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

The level of neurotransmitters Glutamate and GABA were also measured using magnetic resonance spectroscopy (MRS).

Additionally, the improvement and severity in impulsive aggression behaviors were assessed using validated scales.

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
Model description: A multi-center, double-blind, randomized (1:1), placebo-controlled, parallel-group, 2-arm study

Arm	Type	Receives
High dose SPN-810 (36 mg)	Active comparator	Diagnostic Test: Functional Magnetic Resonance Imaging (fMRI), Diagnostic Test: Magnetic Resonance Spectroscopy (MRS), Behavioral: Point Subtraction Aggression Paradigm (PSAP) Task, Drug: SPN-810Subjects were randomized to receive SPN-810 18 mg twice a day twice each day with and without food, in addition to the stable dose of the optimized ADHD medication.
Placebo	Placebo comparator	Diagnostic Test: Functional Magnetic Resonance Imaging (fMRI), Diagnostic Test: Magnetic Resonance Spectroscopy (MRS), Behavioral: Point Subtraction Aggression Paradigm (PSAP) Task, Drug: PlaceboSubjects were randomized to receive Placebo twice a day twice each day with and without food, in addition to the stable dose of the optimized ADHD medication.

Who may qualify

Ages: 8 to 12 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (2 listed)

Otherwise healthy male or female subjects, aged 8-12 years, inclusive, at the time of screening with primary diagnosis of ADHD and currently receiving monotherapy treatment with an optimized US Food and Drug Administration (FDA)-approved ADHD medication.
Impulsive aggression (IA) confirmed at screening using the R-MOAS and the Vitiello Aggression Scale.

Key exclusion criteria (5 listed)

Current or lifetime diagnosis of epilepsy, major depressive disorder, bipolar disorder, schizophrenia or related disorder, personality disorder, Tourette's disorder, fetal alcohol syndrome, or psychosis not otherwise specified.
Currently meeting DSM criteria for autism spectrum disorder, pervasive developmental disorder, obsessive-compulsive disorder, post-traumatic stress disorder.
Known or suspected IQ <70, pregnancy, substance or alcohol abuse.
Known history of implanted brain stimulator, vagal nerve stimulator, ventriculoperitoneal shunt, cardiac pacemaker, orthodontic braces, or implanted medication port. Visual and hearing (≥25 dB) impairment.
Pre-existing medical or psychological conditions that preclude being in the MRI scanner (e.g., claustrophobia, morbid obesity, or marked anxiety about the procedure).

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
Functional Magnetic Resonance Imaging (fMRI)Neural brain activity measured by fMRI	Diagnostic test	High dose SPN-810 (36 mg), Placebo
Magnetic Resonance Spectroscopy (MRS)Glutamate and GABA levels measured by MRS	Diagnostic test	High dose SPN-810 (36 mg), Placebo
Point Subtraction Aggression Paradigm (PSAP) TaskAggression score measured by the PSAP task	Behavioural	High dose SPN-810 (36 mg), Placebo
SPN-810Treatment of SPN-810 (36 mg) on neuronal brain activity, GABA and Glutamate levels and on the aggression score	Drug	High dose SPN-810 (36 mg)
PlaceboTreatment of placebo on neuronal brain activity, GABA and Glutamate levels and on the aggression score	Drug	Placebo

Primary outcome

Aggression-related Change in the Whole Brain in BOLD (Blood Oxygenation Level-dependent) Signal fMRI Contrast in Response to the PSAP Task
Time frame: Baseline/Visit 2 (Day -5) to Visit 5 (Day 28) for a total of 4 weeks.
The primary endpoint was the aggression-related change in the whole brain in BOLD signal fMRI contrast in response to the PSAP task. BOLD fMRI contrast (neural activation) investigates brain activity by measuring the change in blood oxygenation. Change in brain activity was measured by a change in BOLD response in brain regions during the aggressive response relative to the monetary response, where the aggression was defined as the number of Option 2 presses (aggressive response) divided by the total number of button presses and the number of provocations. Change of aggression-related MRI signal was acquired at baseline and 4 weeks after SPN-810 treatment. A positive number represents an increase in activity. Region of interest is described by the location of the peak value and described by Montreal Neurological Institute (MNI) X, Y, Z coordinates. Data represent the post-treatment minus baseline change in BOLD contrast Aggressive Response> Monetary Response.
Provocation Event - Related Change in the Whole Brain in BOLD Signal fMRI Contrast in Response to the PSAP Task
Time frame: Baseline/Visit 2 (Day -5) to Visit 5 (Day 28) for a total of 4 weeks.
BOLD (blood oxygenation level-dependent) fMRI contrast (neural activation) investigates brain activity by measuring the change in blood oxygenation. It was collected during the PSAP behavioral task while playing the game: the participants play a computer game in which they can steal points (simulating an aggressive behavior) or have points stolen by the opponent (provocation event) by pressing Option 1, 2 or 3 on a keypad a set number of times to achieve a specific outcome. A positive number represents an increase in activity. The region of interest is described by the location of the peak value within that cluster and described by Montreal Neurological Institute (MNI) X, Y, and Z coordinates. Data represent the post-treatment minus baseline change in BOLD contrast Provocation Event >Monetary Response.
Effect of SPN-810 on the Aggressions Score
Time frame: Baseline/Visit 2 (Day -5) to Visit 5 (Day 28) for a total of 4 weeks.
The Point Subtraction Aggression Paradigm (PSAP) is a behavioral aggression paradigm consisting of a computer game in which each participant plays against a computer to earn points. The subject can steal points (i.e., aggressive behavior) or have points stolen by the opponent (i.e., provocation). The subject can press 1 of 3 buttons on a keypad a set number of times. By pressing the button for Option 1, 100 times, the subject will earn a point; pressing the button for Option 2, 20 consecutive times is the "aggression" action that results in stealing a point from the opponent; pressing Option 3, 20 times protects the subject from the opponent's attempt to steal points (i.e., money). The aggression score is averaged across two sessions and calculated as the number of Option 2 button presses divided by the sum of total button presses and the number of provocation events received, with a range minimum = 1, maximum = 143. The higher scores reflect increased aggression.

1 secondary outcome

Effect of SPN-810 on GABA and Glutamate Levels Using Magnetic Resonance Spectroscopy (MRS)
Time frame: Baseline/Visit 2 (Day -5) to Visit 5 (Day 28) for a total of 4 weeks.

Results and safety

Results posted to the registry on 2 May 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	4	4
High Dose SPN-810 (36 mg)	3	2

Primary outcome: Aggression-related Change in the Whole Brain in BOLD (Blood Oxygenation Level-dependent) Signal fMRI Contrast in Response to the PSAP Task

Time frame: Baseline/Visit 2 (Day -5) to Visit 5 (Day 28) for a total of 4 weeks.. Mean (95% Confidence Interval). Unit: Voxels

Measure	SPN-810 (36 mg) > Placebo n = 2	Placebo > SPN-810 (36 mg) n = 4
Inferior Occipital Gyrus/Cerebellum: Montreal Neurological Institute coordinates -29.5, 62.5, -4.5	353 (310.6 to 395.4)	0 (0 to 0)
Right Fusiform Gyrus/Inferior Occipital Cortex: Montreal Neurological Institute 32.5, 52.5, 23.5	258 (223.1 to 292.9)	0 (0 to 0)
Left Angular Gyrus (WM): Montreal Neurological Institute coordinates 4.5, 84.5, 35.5	173 (145.2 to 200.8)	0 (0 to 0)
Left Cuneus: Montreal Neurological Institute coordinates -23.5, 96.5, 5.5	145 (124.6 to 165.4)	0 (0 to 0)
Right Middle Occipital Gyrus: Montreal Neurological Institute coordinates -1.5, 64.5, 57.5	133 (114.2 to 151.8)	0 (0 to 0)
Medial Precuneus: Montreal Neurological Institute coordinates -33.5, 34.5, 47.5	128 (111.3 to 144.7)	0 (0 to 0)
Right Postcentral Gyrus: Montreal Neurological Institute coordinates -29.5, 62.5, -4.5	110 (95.1 to 124.9)	0 (0 to 0)
Superior Medial Frontal Gyrus: Montreal Neurological Institute coordinates 2.5, -47.5, 39.5	0 (0 to 0)	329 (288.6 to 369.4)

Population analysed: Completed population included all subjects randomized, who had a Baseline imaging scan (including the anatomical scan) and post-treatment imaging scans.

Primary outcome: Provocation Event - Related Change in the Whole Brain in BOLD Signal fMRI Contrast in Response to the PSAP Task

Time frame: Baseline/Visit 2 (Day -5) to Visit 5 (Day 28) for a total of 4 weeks.. Mean (95% Confidence Interval). Unit: Voxels

Measure	SPN-810 (36 mg) > Placebo n = 2	Placebo > SPN-810 (36 mg) n = 4
Right Postcentral Gyrus: Montreal Neurological Institute coordinates: -31.5, 30.5, 43.5	318 (276.3 to 359.7)	0 (0 to 0)
Left Middle/Inferior Temporal Gyrus: Montreal Neurological Institute coordinates 52.5, 16.5, -24.5	137 (117.5 to 156.5)	0 (0 to 0)
Medial Cerebellum: Montreal Neurological Institute coordinates: 12.5, 50.5 -32.5	0 (0 to 0)	123 (104.1 to 141.9)
Left Inferior Frontal Gyrus: Montreal Neurological Institute coordinates: 42.5, -15.5, 19.5	0 (0 to 0)	122 (105.0 to 139.0)
Right Cerebellum: Montreal Neurological Institute coordinates: -23.5, 70.5, -24.5	0 (0 to 0)	109 (94.4 to 123.6)

Population analysed: Completed population included all subjects randomized, who had a Baseline imaging scan (including the anatomical scan) and post-treatment imaging scans.

Primary outcome: Effect of SPN-810 on the Aggressions Score

Time frame: Baseline/Visit 2 (Day -5) to Visit 5 (Day 28) for a total of 4 weeks.. Mean (Standard Deviation). Unit: score on a scale

Measure	Placebo n = 4	High Dose SPN-810 (36 mg) n = 2
Baseline/Visit 2	8.43 (9.22)	10.23 (6.21)
Visit 5	9.26 (5.50)	4.02 (2.60)

Population analysed: Completed population included all subjects randomized, who had a Baseline imaging scan (including the anatomical scan) and post-treatment imaging scans.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Visit 3 (Day 1) to Visit 6 (Week5)-End of Study, a total of 5 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 4 (0%)	2 of 4 (50%)	0 of 4
High Dose SPN-810	0 of 3 (0%)	1 of 3 (33.3%)	0 of 3

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 9046983Cherek DR, Moeller FG, Schnapp W, Dougherty DM. Studies of violent and nonviolent male parolees: I. Laboratory and psychometric measurements of aggression. Biol Psychiatry. 1997 Mar 1;41(5):514-22. doi: 10.1016/s0006-3223(96)00059-5.
Background: PubMed 26292852Bubenzer-Busch S, Herpertz-Dahlmann B, Kuzmanovic B, Gaber TJ, Helmbold K, Ullisch MG, Baurmann D, Eickhoff SB, Fink GR, Zepf FD. Neural correlates of reactive aggression in children with attention-deficit/hyperactivity disorder and comorbid disruptive behaviour disorders. Acta Psychiatr Scand. 2016 Apr;133(4):310-23. doi: 10.1111/acps.12475. Epub 2015 Aug 21.

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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. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 2 inclusion and 5 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: stopped early, as of the sponsor's last update on 2 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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?

Yes. Results are posted in the registry (first posted 2 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Aggression-related Change in the Whole Brain in BOLD (Blood Oxygenation Level-dependent) Signal fMRI Contrast in Response to the PSAP Task (time frame: Baseline/Visit 2 (Day -5) to Visit 5 (Day 28) for a total of 4 weeks.). The study lists 3 primary outcomes in all. 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 NCT03638466, which also lists 2 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 2 May 2025.