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RECRUITING
NCT04219280
PHASE4

Evaluating Treatment of ADHD in Children with Down Syndrome

Sponsor: Children's Hospital Medical Center, Cincinnati

View on ClinicalTrials.gov

Summary

Children with Down syndrome (DS) have a 3-5 time greater prevalence of Attention Deficit Hyperactivity Disorder (ADHD) than typically developing (TD) children. Despite this higher risk of ADHD, rates of stimulant medication treatment are disproportionately low in children with DS+ADHD, even though stimulants are the most efficacious ADHD treatment and are recommended by consensus guidelines for use in children with intellectual disability and ADHD. The investigators propose the first randomized clinical trial (RCT) of stimulant medication in children with DS+ADHD. This RCT may provide evidence regarding the short- and long-term safety and efficacy of stimulant use in children with DS+ADHD, both with and without CHD. All children enrolled in the study will complete a comprehensive assessment battery evaluating ADHD diagnostic criteria, as well as behavioral, cognitive, academic, and functional impairments.

Official title: Evaluating Assessment and Medication Treatment of ADHD in Children with Down Syndrome

Key Details

Gender

All

Age Range

6 Years - 17 Years

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2020-10-02

Completion Date

2025-09-30

Last Updated

2025-01-15

Healthy Volunteers

Yes

Interventions

DRUG

Quillivant XR

Long-lasting liquid solution of Quillivant XR.

DRUG

Placebo

Liquid solution to mimic the color and taste of Quillivant XR.

Locations (4)

University of California Davis MIND Institute

Sacramento, California, United States

Boston Children's Hospital

Boston, Massachusetts, United States

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States