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Active, not recruiting Phase 4 Interventional Accepts healthy volunteers

Evaluating Treatment of ADHD in Children With Down Syndrome

ClinicalTrials.gov ID: NCT04219280

Public ClinicalTrials.gov record NCT04219280. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 7, 2026, 3:17 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Evaluating Assessment and Medication Treatment of ADHD in Children With Down Syndrome

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT04219280
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Phase 4
Enrollment
100 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
6 Years to 17 Years
Sex
All
Healthy volunteers
Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Oct 1, 2020
Primary completion
Aug 30, 2026
Completion
Aug 30, 2026
Last update posted
Aug 9, 2026

2020 – 2026

United States locations

U.S. sites
4
U.S. states
4
U.S. cities
4
Facility City State ZIP Site status
University of California Davis MIND Institute Sacramento California 95817
Boston Children's Hospital Boston Massachusetts 02115
Cincinnati Children's Hospital Medical Center Cincinnati Ohio 45229
University of Pittsburgh Medical Center Pittsburgh Pennsylvania 15203

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04219280, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Aug 9, 2026 · Synced Sep 7, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT04219280 live on ClinicalTrials.gov.

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