NCT03638466

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

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Supernus Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 8 Years – 12 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2019-05-30
• Primary completion: 2019-11-07
• Completion: 2019-11-07
• First posted: 2018-08-20
• Last updated: 2025-05-02
• Results posted: 2025-05-02

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study