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 |
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.
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.
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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6141 Sunset Dr # 301
South Miami, Florida 33143
South Miami, Florida 33143
(305) 598-3125
Phone: 305-598-3125
Miami Research Associates Miami Research Associates (MRA) is the largest privately-owned multi-specialty clinical research center...
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811 Juniper St NE
Atlanta, Georgia 30308
Atlanta, Georgia 30308
(404) 881-5800
Phone: 404-881-5800
Atlanta Center for Medical Research Welcome to the Atlanta Center for Medical Research, a leader...
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Baltimore, Maryland 21205
Phone: 443-923-9326
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Cincinnati, Ohio 45219
Phone: 513-558-2989
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1581 Dodd Drive
Columbus, Ohio 43210
Columbus, Ohio 43210
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3133 Lakeland Hills Boulevard
Lakeland, Florida 33805
Lakeland, Florida 33805
Phone: 863-940-2087
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Saint Charles, Missouri 63304
Phone: 636-946-8032
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Tampa, Florida 33613
Phone: 813-974-2832
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Washington, District of Columbia 20310
Phone: 202-476-3042
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