Trial · NCT03638466
Exploratory fMRI Study on the Treatment for Impulsive Aggression in Children With ADHD
NCT03638466, Phase 2, Terminated, Supernus Pharmaceuticals, Inc.; results first posted 2025-05-02
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Exploratory fMRI Study on the Treatment for Impulsive Aggression in Children With ADHD. Trials, record NCT03638466. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03638466
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Exploratory fMRI Study on the Treatment for Impulsive Aggression in Children With ADHD
- NCT number
- NCT03638466
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 7 participants, actual
- Lead sponsor
- Supernus Pharmaceuticals, Inc.
- Conditions
- Attention Deficit Hyperactivity Disorder (ADHD), Impulsive Aggression
- Interventions
- Functional Magnetic Resonance Imaging (fMRI), Magnetic Resonance Spectroscopy (MRS), Point Subtraction Aggression Paradigm (PSAP) Task, SPN-810, Placebo
- First posted
- 2018-08-20
- Last updated
- 2025-05-02
- Results first posted
- 2025-05-02
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Aggression-related Change in the Whole Brain in BOLD (Blood Oxygenation Level-dependent) Signal fMRI Contrast in Response to the PSAP Task | 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. |
| Primary | Provocation Event - Related Change in the Whole Brain in BOLD Signal fMRI Contrast in Response to the PSAP Task | 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. |
| Primary | Effect of SPN-810 on the Aggressions Score | 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. |
| Secondary | Effect of SPN-810 on GABA and Glutamate Levels Using Magnetic Resonance Spectroscopy (MRS) | Baseline/Visit 2 (Day -5) to Visit 5 (Day 28) for a total of 4 weeks. | 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. |
| Other | Effect of SPN-810 on Impulsive Aggression Measured by the Clinical Global Impression-Severity (CGI-S) Scale | From Visit 1 (Day -30) to two time points: Visit 4 (Day 21) and Visit 6 (Day 35). | The Clinical Global Impression - Severity of Illness (CGI-S) is a single item clinician rating of clinician's assessment of the severity of IA behaviors. CGI-S was evaluated by the Investigator on a 7- point scale with 1=Normal, 2=Borderline ill, 3=Mildly ill, 4=Moderately ill, 5=Markedly ill, 6=Severely ill, and 7=Extremely ill. Data represent the change between Baseline (Visit 1/Day -30) and two time points: Visit 4 (Day 21) and Visit 6 (Day 35). |
| Other | Effect of SPN-810 on Impulsive Aggression Measured by the Clinical Global Impression-Improvement (CGI-I) Scale | Visit 4 (Day 21) and Visit 6 (Day 35), for a total of 2 weeks. | The Clinical Global Impression - Improvement Scale (CGI-I) is an assessment of how much the patient's illness has improved or worsened relative to a baseline state at the beginning of treatment. CGI-I was evaluated by the Investigator on a 7-point scale with 1=very much improved, 2= much improved, 3= minimally improved, 4= no change, 5= minimally worse, 6= much worse, 7= very much worse. |
| Other | Effect of SPN-810 on the Retrospective-Modified Overt Aggression Scale (R-MOAS) Score | Visit 1 (Day -30) to Visit 4 (Day 21) and Visit 6 (Day 35). | R-MOAS scale gauges the severity of aggressive behavior: the frequency of the 16 behaviors is rated over the past week in 4 areas (a-d). For each open question in each area, the parent rates the aggressive behaviors on a scale from 0 to 5 or more times. To each area corresponds a weighted category: 1(a), 4(b), 2(c) and 3(d). Therefore, the sum of each area yields a maximum weighted score of 20 (a), 120 (b), 60 (c) and 90 (c). The total score is the sum of the four area scores or 0-290, the higher the score, the more severe the aggressive behavior is. Data represent the change from baseline at each visit. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Aggression-related Change in the Whole Brain in BOLD (Blood Oxygenation Level-dependent) Signal fMRI Contrast in Response to the PSAP Task | Baseline/Visit 2 (Day -5) to Visit 5 (Day 28) for a total of 4 weeks. | Completed population included all subjects randomized, who had a Baseline imaging scan (including the anatomical scan) and post-treatment imaging scans. | Voxels | MEAN |
| PRIMARY | Provocation Event - Related Change in the Whole Brain in BOLD Signal fMRI Contrast in Response to the PSAP Task | Baseline/Visit 2 (Day -5) to Visit 5 (Day 28) for a total of 4 weeks. | Completed population included all subjects randomized, who had a Baseline imaging scan (including the anatomical scan) and post-treatment imaging scans. | Voxels | MEAN |
| PRIMARY | Effect of SPN-810 on the Aggressions Score | Baseline/Visit 2 (Day -5) to Visit 5 (Day 28) for a total of 4 weeks. | Completed population included all subjects randomized, who had a Baseline imaging scan (including the anatomical scan) and post-treatment imaging scans. | score on a scale | MEAN |
| SECONDARY | Effect of SPN-810 on GABA and Glutamate Levels Using Magnetic Resonance Spectroscopy (MRS) | Baseline/Visit 2 (Day -5) to Visit 5 (Day 28) for a total of 4 weeks. | Completed population included all subjects randomized, who had a Baseline imaging scan (including the anatomical scan) and post-treatment imaging scans | mM | MEAN |
| OTHER_PRE_SPECIFIED | Effect of SPN-810 on Impulsive Aggression Measured by the Clinical Global Impression-Severity (CGI-S) Scale | From Visit 1 (Day -30) to two time points: Visit 4 (Day 21) and Visit 6 (Day 35). | Completed population included all subjects randomized, who had a Baseline imaging scan (including the anatomical scan) and post-treatment imaging scans. | score on a scale | MEAN |
| OTHER_PRE_SPECIFIED | Effect of SPN-810 on Impulsive Aggression Measured by the Clinical Global Impression-Improvement (CGI-I) Scale | Visit 4 (Day 21) and Visit 6 (Day 35), for a total of 2 weeks. | Completed population included all subjects randomized, who had a Baseline imaging scan (including the anatomical scan) and post-treatment imaging scans. | score on a scale | MEAN |
| OTHER_PRE_SPECIFIED | Effect of SPN-810 on the Retrospective-Modified Overt Aggression Scale (R-MOAS) Score | Visit 1 (Day -30) to Visit 4 (Day 21) and Visit 6 (Day 35). | Completed population included all subjects randomized, who had a Baseline imaging scan (including the anatomical scan) and post-treatment imaging scans. | score on a scale | MEAN |
Source ClinicalTrials.gov
Results by group56
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Aggression-related Change in the Whole Brain in BOLD (Blood Oxygenation Level-dependent) Signal fMRI Contrast in Response to the PSAP Task | SPN-810 (36 mg) > Placebo | Inferior Occipital Gyrus/Cerebellum: Montreal Neurological Institute coordinates -29.5, 62.5, -4.5 | 353 | 95% Confidence Interval 310.6 to 395.4 | Voxels |
| Aggression-related Change in the Whole Brain in BOLD (Blood Oxygenation Level-dependent) Signal fMRI Contrast in Response to the PSAP Task | Placebo > SPN-810 (36 mg) | Inferior Occipital Gyrus/Cerebellum: Montreal Neurological Institute coordinates -29.5, 62.5, -4.5 | 0 | 95% Confidence Interval 0 to 0 | Voxels |
| Aggression-related Change in the Whole Brain in BOLD (Blood Oxygenation Level-dependent) Signal fMRI Contrast in Response to the PSAP Task | SPN-810 (36 mg) > Placebo | Right Fusiform Gyrus/Inferior Occipital Cortex: Montreal Neurological Institute 32.5, 52.5, 23.5 | 258 | 95% Confidence Interval 223.1 to 292.9 | Voxels |
| Aggression-related Change in the Whole Brain in BOLD (Blood Oxygenation Level-dependent) Signal fMRI Contrast in Response to the PSAP Task | Placebo > SPN-810 (36 mg) | Right Fusiform Gyrus/Inferior Occipital Cortex: Montreal Neurological Institute 32.5, 52.5, 23.5 | 0 | 95% Confidence Interval 0 to 0 | Voxels |
| Aggression-related Change in the Whole Brain in BOLD (Blood Oxygenation Level-dependent) Signal fMRI Contrast in Response to the PSAP Task | SPN-810 (36 mg) > Placebo | Left Angular Gyrus (WM): Montreal Neurological Institute coordinates 4.5, 84.5, 35.5 | 173 | 95% Confidence Interval 145.2 to 200.8 | Voxels |
| Aggression-related Change in the Whole Brain in BOLD (Blood Oxygenation Level-dependent) Signal fMRI Contrast in Response to the PSAP Task | Placebo > SPN-810 (36 mg) | Left Angular Gyrus (WM): Montreal Neurological Institute coordinates 4.5, 84.5, 35.5 | 0 | 95% Confidence Interval 0 to 0 | Voxels |
| Aggression-related Change in the Whole Brain in BOLD (Blood Oxygenation Level-dependent) Signal fMRI Contrast in Response to the PSAP Task | SPN-810 (36 mg) > Placebo | Left Cuneus: Montreal Neurological Institute coordinates -23.5, 96.5, 5.5 | 145 | 95% Confidence Interval 124.6 to 165.4 | Voxels |
| Aggression-related Change in the Whole Brain in BOLD (Blood Oxygenation Level-dependent) Signal fMRI Contrast in Response to the PSAP Task | Placebo > SPN-810 (36 mg) | Left Cuneus: Montreal Neurological Institute coordinates -23.5, 96.5, 5.5 | 0 | 95% Confidence Interval 0 to 0 | Voxels |
| Aggression-related Change in the Whole Brain in BOLD (Blood Oxygenation Level-dependent) Signal fMRI Contrast in Response to the PSAP Task | SPN-810 (36 mg) > Placebo | Right Middle Occipital Gyrus: Montreal Neurological Institute coordinates -1.5, 64.5, 57.5 | 133 | 95% Confidence Interval 114.2 to 151.8 | Voxels |
| Aggression-related Change in the Whole Brain in BOLD (Blood Oxygenation Level-dependent) Signal fMRI Contrast in Response to the PSAP Task | Placebo > SPN-810 (36 mg) | Right Middle Occipital Gyrus: Montreal Neurological Institute coordinates -1.5, 64.5, 57.5 | 0 | 95% Confidence Interval 0 to 0 | Voxels |
1 to 10 of 56Source ClinicalTrials.gov
See all 56 results by groupParticipant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 4 | |
| Overall Study | STARTED | High Dose SPN-810 (36 mg) | 3 | |
| Overall Study | Randomized Population | Placebo | 4 | |
| Overall Study | Randomized Population | High Dose SPN-810 (36 mg) | 3 | |
| Overall Study | Completed Population | Placebo | 4 | |
| Overall Study | Completed Population | High Dose SPN-810 (36 mg) | 2 | |
| Overall Study | COMPLETED | Placebo | 4 | |
| Overall Study | COMPLETED | High Dose SPN-810 (36 mg) | 2 | |
| Overall Study | NOT COMPLETED | Placebo | 0 | |
| Overall Study | NOT COMPLETED | High Dose SPN-810 (36 mg) | 1 |
Source ClinicalTrials.gov
Adverse events6
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Fatigue | General disorders | Placebo | 1 | 4 | |
| other | Fatigue | General disorders | High Dose SPN-810 | 0 | 3 | |
| other | Decrease appetite | Metabolism and nutrition disorders | Placebo | 2 | 4 | |
| other | Decrease appetite | Metabolism and nutrition disorders | High Dose SPN-810 | 0 | 3 | |
| other | Blood Prolactin Increased | Investigations | Placebo | 0 | 4 | |
| other | Blood Prolactin Increased | Investigations | High Dose SPN-810 | 1 | 3 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 4 |
| Total, all-cause mortality | High Dose SPN-810 | 0 | 3 |
| Total, other adverse events | Placebo | 2 | 4 |
| Total, other adverse events | High Dose SPN-810 | 1 | 3 |
| Total, serious adverse events | Placebo | 0 | 4 |
| Total, serious adverse events | High Dose SPN-810 | 0 | 3 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| High Dose SPN-810 vs Placebo: deaths from any cause | Trial comparisons |
| High Dose SPN-810 vs Placebo: serious adverse events | Trial comparisons |
Tests1
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as |
|---|---|
| Point Subtraction Aggression Task | Primary outcome |
Source ConductCognition
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03638466
GET https://conductscience.org/api/trials/v1/NCT03638466/results?page=2