Treatment of Impulsive Aggression (IA) in Adolescent With ADHD in Conjunction With Standard ADHD Treatment
NCT ID: NCT03597503
Last Updated: 2024-04-24
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
41 participants
INTERVENTIONAL
2018-07-31
2020-01-22
Brief Summary
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Detailed Description
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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.
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Flexible dose of SPN-810
Subjects treated with flexible dose of SPN-810
SPN-810
Flexible dose
Placebo
Subjects treated with Placebo
Placebo
Placebo
Interventions
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SPN-810
Flexible dose
Placebo
Placebo
Eligibility Criteria
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Inclusion Criteria
* IA confirmed at screening using R-MOAS scale and Vitiello Aggression Questionnaire.
Exclusion Criteria
* 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.
12 Years
17 Years
ALL
No
Sponsors
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Supernus Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Locations
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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
Texas Physicians Medical Research Group
Arlington, Texas, United States
BioBehavioral Research of Austin P.C.
Austin, Texas, United States
Gaolin Research, LLC
Beaumont, Texas, United States
Relaro Medical Trials
Dallas, Texas, United States
InSite Clinical Research
DeSoto, Texas, United States
Houston Clinical Trials
Houston, Texas, United States
Dicovery MM Services Inc. Houston
Houston, Texas, United States
FMCScience
Lampasas, Texas, United States
Discovery MM Service, Inc. Missouri
Missouri City, Texas, United States
Clinical Trials of Texas, Inc.
San Antonio, Texas, United States
Family Psychiatry of the Woodlands
The Woodlands, Texas, United States
Ericksen Research & Development
Clinton, Utah, United States
Aspen Clinical Research
Orem, Utah, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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810P503
Identifier Type: -
Identifier Source: org_study_id
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