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

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Attention Deficit Hyperactivity Disorder

In brief

The purpose of this study was 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.

Key facts

Study ID

NCT03597503

Run by

Supernus Pharmaceuticals, Inc.

People needed

41

Starts

2018-07-31

Expected to finish

2020-01-22

Last updated by the study team

2024-04-24

Who can join

Age: 12 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 confirmed at screening using R-MOAS scale and Vitiello Aggression Questionnaire.

You may not qualify if…

• 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.

Where it is running

• ProScience — Culver City, California, United States
• Neuropsychiatric Research Center of Orange County — Orange, 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
• Clinical Neuroscience Solutions, Inc — Jacksonville, Florida, United States
• Meridien Research aka Florida Clinical Research Center, LLC — Lakeland, Florida, United States
• Florida Clinical Research Center, LLC. — Maitland, Florida, United States
• Miami Clinical Research — Miami, 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
• Capstone Clinical Research — Libertyville, Illinois, United States
• AMR Conventions Research — Naperville, Illinois, United States
• Psychiatric Associates — Overland Park, Kansas, United States
• Hugo W Moser Research Institute at Kennedy Krieger — Baltimore, Maryland, United States
• St. Charles Psychiatric Associates Midwest Research Center — Saint Charles, Missouri, United States
• Alivation Research, LLC — Lincoln, Nebraska, United States
• Hassmann Research Institute — Berlin, New Jersey, United States
• Finger Lakes Clinical Research — Rochester, New York, United States
• University of Cincinnati Department of Psychiatry and Behavioral Neuroscience — Cincinnati, Ohio, United States
• Ohio State University Nisonger Center Clinical Trials Program — Columbus, Ohio, United States
• Oklahoma Clinical Research Center — Oklahoma City, Oklahoma, United States
• Paradigm Research Professionals — Oklahoma City, Oklahoma, United States
• CNS Healthcare — Memphis, Tennessee, United States

Full record on ClinicalTrials.gov

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