Treatment of Impulsive Aggression in Subjects With ADHD in Conjunction With Standard ADHD Treatment (CHIME 2)

Completed · Phase 3 · Has a placebo group

Conditions studied: Attention Deficit Hyperactivity Disorder (ADHD)

In brief

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 297 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.

Key facts

Study ID

NCT02618434

Run by

Supernus Pharmaceuticals, Inc.

People needed

297

Starts

2016-02-16

Expected to finish

2020-02-14

Last updated by the study team

2024-03-18

Who can join

Age: 6 and older, up to 12. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Current or lifetime diagnosis of epilepsy, major depressive disorder, bipolar disorder, schizophrenia or a 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 the primary diagnosis.
• Known or suspected intelligence quotient (IQ) < 70, suicidality, pregnancy, or substance or alcohol abuse.

Where it is running

• Metropolitan Neuro Behavioral Institute — Chandler, Arizona, United States
• Woodland International Research Group — Little Rock, Arkansas, United States
• Sun Valley Research Center — Imperial, California, United States
• Alliance for Wellness dba Alliance for Research — Long Beach, California, United States
• ASCLEPES Research Center — Panorama City, California, United States
• MCB Clinical Research Centers, LLC — Colorado Springs, Colorado, United States
• Children's National Medical Center/Children's Research Institute — Washington D.C., District of Columbia, United States
• Gulfcoast Clinical Research Center — Fort Myers, Florida, United States
• Indago Research & Health Center, Inc. — Hialeah, Florida, United States
• Innovative Clinical Research, Inc — Lauderhill, Florida, United States
• Laszlo J. Mate, M.D., P.A. — North Palm Beach, Florida, United States
• APG Research, LLC — Orlando, Florida, United States
• Miami Research Associates — South Miami, Florida, United States
• University of South Florida- Dept. of Psychiatry and Neurosciences — Tampa, Florida, United States
• Atlanta Center for Medical Research — Atlanta, Georgia, United States
• iResearch Atlanta — Decatur, Georgia, United States
• Advanced Clinical Research — Meridian, Idaho, United States
• AMR Conventions Research — Naperville, Illinois, United States
• Pedia Research — Evansville, Indiana, United States
• Pedia Research — Owensboro, Kentucky, United States
• Louisiana State University Health Sciences Center — Shreveport, Louisiana, United States
• St. Charles Psychiatric Associates Midwest Research Center — Saint Charles, Missouri, United States
• Alivation Research, LLC — Lincoln, Nebraska, United States
• Quality Clinical Research — Omaha, Nebraska, United States
• Hassmann Research Institute — Berlin, New Jersey, United States

Full record on ClinicalTrials.gov

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