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



Status:Recruiting
Conditions:Neurology, Psychiatric, Psychiatric
Therapuetic Areas:Neurology, Psychiatry / Psychology
Healthy:No
Age Range:12 - 17
Updated:3/6/2019
Start Date:July 31, 2018
End Date:December 20, 2019
Contact:Ronald Marcus, MD
Email:rmarcus@supernus.com
Phone:301-838-2569

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Assessment of Efficacy and Safety of SPN-810 for the Treatment of Impulsive Aggression (IA) in Adolescent Subjects With Attention Deficit/Hyperactivity Disorder (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.

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.

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.
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