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

Last updated: April 18, 2024
Sponsor: Supernus Pharmaceuticals, Inc.
Overall Status: Terminated

Phase

3

Condition

Anger

Williams Syndrome

Autism Spectrum Disorder (Asd)

Treatment

SPN-810

Placebo

Clinical Study ID

NCT03597503
810P503
  • Ages 12-17
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Otherwise, healthy non-smoking, male and females adolescents (12-17 years of age atthe time of screening) with a primary diagnosis of ADHD and currently taking anoptimized FDA-approved ADHD medication.
  • IA confirmed at screening using R-MOAS scale and Vitiello Aggression Questionnaire.

Exclusion

Exclusion Criteria:

  • History or current diagnosis of epilepsy, major depressive disorder, bipolar disorder,schizophrenia and other psychotic disorders, personality disorder, Tourette's syndromeor dissociative disorder, autism spectrum disorder, pervasive developmental disorder,obsessive compulsive disorder, post-traumatic stress disorder, or intermittentexplosive disorder.
  • Currently meeting DSM-5 criteria for pervasive developmental disorder, obsessivecompulsive disorder, post-traumatic stress disorder or intermittent explosivedisorder.
  • Known or suspected intelligence quotient (IQ) <70, active suicidal plan/intent oractive suicidal thought, criminal arrest, alcohol or drug use or pregnancy.

Study Design

Total Participants: 41
Treatment Group(s): 2
Primary Treatment: SPN-810
Phase: 3
Study Start date:
July 31, 2018
Estimated Completion Date:
January 22, 2020

Study Description

This study was an addition to the 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 was administered in patients diagnosed with ADHD and associated features of IA, who were currently treated with an FDA-approved standard ADHD treatment and displayed persistent IA behaviors. The frequency of impulsive aggressive behaviors was assessed as a primary outcome.

.

Connect with a study center

  • ProScience

    Culver City, California 90230
    United States

    Site Not Available

  • Neuropsychiatric Research Center of Orange County

    Orange, California 92868
    United States

    Site Not Available

  • MCB Clinical Research Centers, LLC

    Colorado Springs, Colorado 80910
    United States

    Site Not Available

  • Children's National Medical Center/Children's Research Institute

    Washington, District of Columbia 20310
    United States

    Site Not Available

  • Clinical Neuroscience Solutions, Inc

    Jacksonville, Florida 32217
    United States

    Site Not Available

  • Meridien Research aka Florida Clinical Research Center, LLC

    Lakeland, Florida 33805
    United States

    Site Not Available

  • Florida Clinical Research Center, LLC.

    Maitland, Florida 32751
    United States

    Site Not Available

  • Miami Clinical Research

    Miami, Florida 33155
    United States

    Site Not Available

  • Miami Research Associates

    South Miami, Florida 33143
    United States

    Site Not Available

  • University of South Florida- Dept. of Psychiatry and Neurosciences

    Tampa, Florida 33613
    United States

    Site Not Available

  • Atlanta Center for Medical Research

    Atlanta, Georgia 30331
    United States

    Site Not Available

  • iResearch Atlanta

    Decatur, Georgia 30030
    United States

    Site Not Available

  • Capstone Clinical Research

    Libertyville, Illinois 60048
    United States

    Site Not Available

  • AMR Conventions Research

    Naperville, Illinois 60563
    United States

    Site Not Available

  • Psychiatric Associates

    Overland Park, Kansas 66211
    United States

    Site Not Available

  • Hugo W Moser Research Institute at Kennedy Krieger

    Baltimore, Maryland 21205
    United States

    Site Not Available

  • St. Charles Psychiatric Associates Midwest Research Center

    Saint Charles, Missouri 63304
    United States

    Site Not Available

  • Alivation Research, LLC

    Lincoln, Nebraska 68526
    United States

    Site Not Available

  • Hassmann Research Institute

    Berlin, New Jersey 08009
    United States

    Site Not Available

  • Finger Lakes Clinical Research

    Rochester, New York 14618
    United States

    Site Not Available

  • University of Cincinnati Department of Psychiatry and Behavioral Neuroscience

    Cincinnati, Ohio 45219
    United States

    Site Not Available

  • Ohio State University Nisonger Center Clinical Trials Program

    Columbus, Ohio 43210
    United States

    Site Not Available

  • Oklahoma Clinical Research Center

    Oklahoma City, Oklahoma 73112
    United States

    Site Not Available

  • Paradigm Research Professionals

    Oklahoma City, Oklahoma 73118
    United States

    Site Not Available

  • CNS Healthcare

    Memphis, Tennessee 38119
    United States

    Site Not Available

  • Texas Physicians Medical Research Group

    Arlington, Texas 76014
    United States

    Site Not Available

  • BioBehavioral Research of Austin P.C.

    Austin, Texas 78759
    United States

    Site Not Available

  • Gaolin Research, LLC

    Beaumont, Texas 77702
    United States

    Site Not Available

  • Relaro Medical Trials

    Dallas, Texas 75243
    United States

    Site Not Available

  • InSite Clinical Research

    DeSoto, Texas 75115
    United States

    Site Not Available

  • Dicovery MM Services Inc. Houston

    Houston, Texas 77061
    United States

    Site Not Available

  • Houston Clinical Trials

    Houston, Texas 08009
    United States

    Site Not Available

  • FMCScience

    Lampasas, Texas 76550
    United States

    Site Not Available

  • Discovery MM Service, Inc. Missouri

    Missouri City, Texas 77459
    United States

    Site Not Available

  • Clinical Trials of Texas, Inc.

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Family Psychiatry of the Woodlands

    The Woodlands, Texas 77381
    United States

    Site Not Available

  • Ericksen Research & Development

    Clinton, Utah 84015
    United States

    Site Not Available

  • Aspen Clinical Research

    Orem, Utah 84058
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.