Treatment of Impulsive Aggression in Subjects With ADHD in Conjunction With Standard ADHD Treatment (CHIME 1)
| Status: | Recruiting |
|---|---|
| Conditions: | Psychiatric, ADHD |
| Therapuetic Areas: | Psychiatry / Psychology, Other |
| Healthy: | No |
| Age Range: | 6 - 12 |
| Updated: | 4/6/2019 |
| Start Date: | January 2016 |
| End Date: | April 2020 |
| Contact: | Stefan Schwabe, MD, PhD |
| Email: | sschwabe@supernus.com |
| Phone: | 301-838-2527 |
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.
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.
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.
We found this trial at
28
sites
8043 Cooper Creek Boulevard
Bradenton, Florida 34201
Bradenton, Florida 34201
Phone: 941-747-7900
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Baltimore, Maryland 21205
Phone: 443-923-9326
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1581 Dodd Drive
Columbus, Ohio 43210
Columbus, Ohio 43210
Phone: 614-685-7373
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