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AWARE: Management of ADHD in Autism Spectrum Disorder
Sponsor: Daniel Coury
Summary
This study is a pragmatic clinical trial examining the comparative effectiveness of two stimulant medications (methylphenidate and amphetamine) in the treatment of ADHD in children and adolescents with autism. Using a sequential, multiple assignment randomization trial (SMART) design the study will not only assess these two medications but also the role of an increasingly popular class of ADHD medication, the alpha-2 agonists. Findings from this study will help improve clinicians' approach to medication selection and reduce the repeated trials of multiple medications that are current standard care.
Official title: Comparative Effectiveness of Pharmacologic Management of ADHD in Children and Youth With Autism Spectrum Disorder
Key Details
Gender
All
Age Range
4 Years - 17 Years
Study Type
INTERVENTIONAL
Enrollment
500
Start Date
2023-10-01
Completion Date
2027-12-30
Last Updated
2025-10-29
Healthy Volunteers
No
Conditions
Interventions
Randomization to either Amphetamine (AMP) class of stimulant medication or Methylphenidate (MPH) class of stimulant medication
Amphetamine (AMP) medication names: Adderall, Adderall XR, Adzenys ER, Adzenys XR-ODT, Dayanavel XR, Dexedrine (spansule), Dexedrine (tablet), Mydayis, Procentra liquid Methylphenidate (MPH) medication names: Adhansia XR, Aptensio XR, Azstarys, Concerta, Cotempla XR-ODT, Daytrana, Focalin, Focalin XR, Jornay PM. Metadate CD, Methylin (liquid), Ritalin, Ritalin LA, Quillichew ER, Quillivant XR (liquid)
Randomization to either Alpha 2 agonist class of medication or alternate class of stimulant.
If first line stimulant therapy (Amphetamine/Methylphenidate) is deemed not effective or tolerable, re-randomization to the alternate stimulant or alpha-2 agonist will occur. If participant is satisfied with first line stimulant treatment, first-line stimulant therapy will continue. Catapres, Clonidine, Guanfacine, Intuniv, Kapvay, Tenex
Locations (12)
University of California, Irvine
Irvine, California, United States
Children's Hospital Los Angeles
Los Angeles, California, United States
Maine Medical Center
Portland, Maine, United States
Massachusetts General Hospital Lurie Center for Autism
Boston, Massachusetts, United States
University of Rochester
Rochester, New York, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Nationwide Children's Hospital
Columbus, Ohio, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
University of Virginia
Charlottesville, Virginia, United States
University of Alberta, Glenrose Rehabilitation Hospital
Edmonton, Canada
Holland Bloorview Kids Rehabilitation Hospital
Toronto, Canada