Ignite Creation Date:
2025-12-24 @ 4:19 PM
Ignite Modification Date:
2026-02-26 @ 6:28 AM
Study NCT ID:
NCT03638466
Status:
TERMINATED
Last Update Posted:
2025-05-02
First Post:
2018-08-16
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Exploratory fMRI Study on the Treatment for Impulsive Aggression in Children With ADHD
Sponsor:
Supernus Pharmaceuticals, Inc.
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2025-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Financial decision
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: