Treatment of Impulsive Aggression in Subjects With ADHD in Conjunction With Standard ADHD Treatment (CHIME 2)
Status: | Recruiting |
---|---|
Conditions: | Psychiatric, ADHD |
Therapuetic Areas: | Psychiatry / Psychology, Other |
Healthy: | No |
Age Range: | 6 - 12 |
Updated: | 3/11/2017 |
Start Date: | March 2015 |
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 patients 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 patients 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.
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2417 Marshall Ave.
Imperial, California 92251
Imperial, California 92251
760-355-0176
Phone: 760-545-0123
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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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Cincinnati, Ohio 45219
Phone: 513-558-2989
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10040 Regency Cir
Omaha, Nebraska 68114
Omaha, Nebraska 68114
(402) 934-0044
Phone: 402-934-0044
Quality Clinical Research, Inc. Welcome to Quality Clinical Research. We originated here in Omaha, NE...
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St. 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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