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

NCT03638466 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2025-05-02

Study results available
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Summary

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.

Conditions

  • Attention Deficit Hyperactivity Disorder (ADHD)
  • Impulsive Aggression

Interventions

DIAGNOSTIC_TEST

Functional Magnetic Resonance Imaging (fMRI)

Neural brain activity measured by fMRI

DIAGNOSTIC_TEST

Magnetic Resonance Spectroscopy (MRS)

Glutamate and GABA levels measured by MRS

BEHAVIORAL

Point Subtraction Aggression Paradigm (PSAP) Task

Aggression score measured by the PSAP task

DRUG

SPN-810

Treatment of SPN-810 (36 mg) on neuronal brain activity, GABA and Glutamate levels and on the aggression score

DRUG

Placebo

Treatment of placebo on neuronal brain activity, GABA and Glutamate levels and on the aggression score

Sponsors & Collaborators

  • Supernus Pharmaceuticals, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
8 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-30
Primary Completion
2019-11-07
Completion
2019-11-07
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03638466 on ClinicalTrials.gov