Treatment of Impulsive Aggression (IA) in Adolescent With ADHD in Conjunction With Standard ADHD Treatment
The purpose of this study is to evaluate the effect of SPN-810 for the treatment of impulsive aggression (IA) in adolescents diagnosed with ADHD when taken in conjunction with standard ADHD treatment.
- Attention Deficit Hyperactivity Disorder
- Eligible Ages
- Between 12 Years and 17 Years
- Eligible Genders
- Accepts Healthy Volunteers
- Otherwise, healthy non-smoking, male and females adolescents (12-17 years of age at the time of screening) with a primary diagnosis of ADHD and currently taking an optimized FDA-approved ADHD medication.
- IA will be confirmed at screening using R-MOAS scale and Vitiello Aggression Questionnaire.
- History or current diagnosis of epilepsy, major depressive disorder, bipolar disorder, schizophrenia and other psychotic disorders, personality disorder, Tourette's syndrome or dissociative disorder, autism spectrum disorder, pervasive developmental disorder, obsessive compulsive disorder, post-traumatic stress disorder, or intermittent explosive disorder.
- Currently meeting DSM-5 criteria for pervasive developmental disorder, obsessive compulsive disorder, post-traumatic stress disorder or intermittent explosive disorder.
- Known or suspected intelligence quotient (IQ) <70, active suicidal plan/intent or active suicidal thought, criminal arrest, alcohol or drug use or pregnancy.
- Phase 3
- Study Type
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- Double-blind, randomized, parallel group, two-arm, placebo-controlled study with flexible dosing
- Primary Purpose
- Triple (Participant, Care Provider, Investigator)
Flexible dose of SPN-810
|Subjects will be treated with flexible dose of SPN-810||
|Subjects will be treated with Placebo||
Children's National and nearby locations
- NCT ID
- Supernus Pharmaceuticals, Inc.
Study ContactRonald Marcus, MD
This study is an addition to the ongoing pediatric studies (CHIME 1 and CHIME 2) to assess the efficacy and safety of SPN-810 in the improvement of impulsive aggression (IA) behaviors in adolescents with ADHD.
SPN-810 will be administered in patients diagnosed with ADHD and associated feature of IA, who are currently being treated with an FDA-approved standard ADHD treatment and with persistent IA behaviors. The frequency of impulsive aggressive behaviors will be assessed as a primary outcome.