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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Attention Deficit Hyperactivity Disorder (ADHD), Impulsive Aggression

In brief

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.

Key facts

Study ID

NCT03638466

Run by

Supernus Pharmaceuticals, Inc.

People needed

7

Starts

2019-05-30

Expected to finish

2019-11-07

Last updated by the study team

2025-05-02

Who can join

Age: 8 and older, up to 12. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

• Meridien Research aka Florida Clinical Research Center, LLC — Lakeland, Florida, United States
• Florida Clinical Research Center, LLC. — Maitland, Florida, United States
• University of South Florida- Dept. of Psychiatry and Neurosciences — Tampa, Florida, United States

Full record on ClinicalTrials.gov

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