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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-30

Study Completion Date

2019-11-07

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Treatment of Impulsive Aggression (IA) in Adolescent With ADHD in Conjunction With Standard ADHD Treatment

NCT03597503

Attention Deficit Hyperactivity Disorder

TERMINATED PHASE3

A Study to Evaluate the Efficacy and Safety of SPN-810 as Adjunctive Therapy in Children With Impulsive Aggression Comorbid With Attention-Deficit/Hyperactivity Disorder (ADHD)

NCT01364662

Impulsive Aggression Comorbid With ADHD

COMPLETED PHASE2

Treatment of Impulsive Aggression in Subjects With ADHD in Conjunction With Standard ADHD Treatment (CHIME 1)

NCT02618408

Attention Deficit Hyperactivity Disorder (ADHD)

COMPLETED PHASE3

The Characteristics of Prepulse Inhibition in Children and Adolescents Suffering From Attention Deficit Disorder

NCT02344784

Attention Deficit Disorder

UNKNOWN

Treatment of Impulsive Aggression in Subjects With ADHD in Conjunction With Standard ADHD Treatment (CHIME 2)

NCT02618434

Attention Deficit Hyperactivity Disorder (ADHD)

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Attention Deficit Hyperactivity Disorder (ADHD) Impulsive Aggression

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

High dose SPN-810 (36 mg)

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.

Group Type ACTIVE_COMPARATOR

Functional Magnetic Resonance Imaging (fMRI)

Intervention Type DIAGNOSTIC_TEST

Neural brain activity measured by fMRI

Magnetic Resonance Spectroscopy (MRS)

Intervention Type DIAGNOSTIC_TEST

Glutamate and GABA levels measured by MRS

Point Subtraction Aggression Paradigm (PSAP) Task

Intervention Type BEHAVIORAL

Aggression score measured by the PSAP task

SPN-810

Intervention Type DRUG

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

Placebo

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.

Group Type PLACEBO_COMPARATOR

Functional Magnetic Resonance Imaging (fMRI)

Intervention Type DIAGNOSTIC_TEST

Neural brain activity measured by fMRI

Magnetic Resonance Spectroscopy (MRS)

Intervention Type DIAGNOSTIC_TEST

Glutamate and GABA levels measured by MRS

Point Subtraction Aggression Paradigm (PSAP) Task

Intervention Type BEHAVIORAL

Aggression score measured by the PSAP task

Placebo

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Functional Magnetic Resonance Imaging (fMRI)

Neural brain activity measured by fMRI

Intervention Type DIAGNOSTIC_TEST

Magnetic Resonance Spectroscopy (MRS)

Glutamate and GABA levels measured by MRS

Intervention Type DIAGNOSTIC_TEST

Point Subtraction Aggression Paradigm (PSAP) Task

Aggression score measured by the PSAP task

Intervention Type BEHAVIORAL

SPN-810

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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.

Exclusion Criteria

* 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).

Minimum Eligible Age

8 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No