Treatment of Impulsive Aggression in Subjects With ADHD in Conjunction With Standard ADHD Treatment (CHIME 2)
NCT ID: NCT02618434
Last Updated: 2024-03-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
297 participants
INTERVENTIONAL
2016-02-16
2020-02-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Low dose SPN-810 (18 mg)
Oral
SPN-810 (18 mg)
Subjects were randomized to receive SPN-810 9 mg twice each day with food, in addition to the stable dose of the optimized ADHD medication determined from the lead-in period. If initiating treatment before noon, patients should start with the morning dose; if afternoon, the evening dose.
High dose SPN-810 (36 mg)
Oral
SPN-810 (36 mg)
Subjects were randomized to receive SPN-810 18 mg twice each day with food, in addition to the stable dose of the optimized ADHD medication determined from the lead-in period. If initiating treatment before noon, patients should start with the morning dose; if afternoon, the evening dose.
Placebo
Oral
Placebo
Subjects were randomized to receive Placebo twice each day with food, in the morning and in the evening, in addition to the stable dose of the optimized ADHD medication determined from the lead-in period. If initiating treatment before noon, patients should start with the morning dose; if afternoon, the evening dose.
Interventions
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SPN-810 (18 mg)
Subjects were randomized to receive SPN-810 9 mg twice each day with food, in addition to the stable dose of the optimized ADHD medication determined from the lead-in period. If initiating treatment before noon, patients should start with the morning dose; if afternoon, the evening dose.
SPN-810 (36 mg)
Subjects were randomized to receive SPN-810 18 mg twice each day with food, in addition to the stable dose of the optimized ADHD medication determined from the lead-in period. If initiating treatment before noon, patients should start with the morning dose; if afternoon, the evening dose.
Placebo
Subjects were randomized to receive Placebo twice each day with food, in the morning and in the evening, in addition to the stable dose of the optimized ADHD medication determined from the lead-in period. If initiating treatment before noon, patients should start with the morning dose; if afternoon, the evening dose.
Eligibility Criteria
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Inclusion Criteria
* Impulsive aggression will be confirmed at screening using R-MOAS and Vitiello Aggression Scale.
Exclusion Criteria
* 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.
6 Years
12 Years
ALL
No
Sponsors
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Supernus Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Locations
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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
Icahn School of Medicine at Mount Sinai
New York, New York, United States
University of Cincinnati Department of Psychiatry and Behavioral Neuroscience
Cincinnati, Ohio, United States
BioBehavioral Research of Austin P.C.
Austin, Texas, United States
InSite Clinical Research
DeSoto, Texas, United States
Houston Clinical Trials
Houston, Texas, United States
Ericksen Research & Development
Clinton, Utah, United States
Pacific Institute of Medical Sciences
Bothell, Washington, 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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810P302
Identifier Type: -
Identifier Source: org_study_id
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