Overview

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

Status:
Completed
Trial end date:
2019-09-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to demonstrate the efficacy, safety and tolerability of SPN-810 in the treatment of impulsive aggression in subjects with Attention Deficit/Hyperactivity Disorder (ADHD) in conjunction with standard ADHD treatment. Approximately 291 subjects aged 6 to 12 years with ADHD and comorbid impulsive aggression will be recruited in this study. The frequency of impulsive aggression behaviors will be assessed as a primary outcome. Additionally, the severity and improvement in impulsive aggression, and quality of life measures for the subject and caregiver will be assessed using validated scales.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Supernus Pharmaceuticals, Inc.
Criteria
Inclusion Criteria:

- Otherwise healthy male or female subjects, age 6 to 12 years at the time of screening
with a primary diagnosis of ADHD and currently receiving monotherapy treatment with an
optimized FDA-approved ADHD medication.

- Impulsive aggression will be confirmed at screening using R-MOAS and 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, or psychosis not otherwise specified.

- Currently meeting DSM criteria for autism spectrum disorder, pervasive developmental
disorder, obsessive compulsive disorder, post-traumatic stress disorder, or any other
anxiety disorder as primary diagnosis.

- Known or suspected intelligence quotient (IQ) < 70, suicidality, pregnancy, or
substance or alcohol abuse.