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Evaluating Treatment of ADHD in Children with Down Syndrome

NCT04219280 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-01-15

No results posted yet for this study

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.

Conditions

  • Down Syndrome
  • ADHD

Interventions

DRUG

Quillivant XR

Long-lasting liquid solution of Quillivant XR.

DRUG

Placebo

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

Sponsors & Collaborators

  • University of California, Davis

    collaborator OTHER

  • University of Pittsburgh Medical Center

    collaborator OTHER

  • Boston Children's Hospital, Boston, MA, USA

    collaborator OTHER

  • Children's Hospital Medical Center, Cincinnati

    lead OTHER

Principal Investigators

  • Anna Esbensen, PhD · Children's Hospital Medical Center, Cincinnati

  • Tanya Froehlich, MD · Children's Hospital Medical Center, Cincinnati

  • Kathleen Angkustsiri, MD · University of California Davis MIND Institute

  • Benjamin Handen, MD · University of Pittsburgh Medical Center

  • Sabrina Sargado, MD · Boston Children's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
FACTORIAL

Eligibility

Min Age
6 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-10-02
Primary Completion
2025-09-30
Completion
2025-09-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04219280 on ClinicalTrials.gov