Evaluating Treatment of ADHD in Children With Down Syndrome

Running, not enrolling · Phase 4 · Has a placebo group

Conditions studied: Down Syndrome, ADHD

In brief

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.

Key facts

Study ID

NCT04219280

Run by

Children's Hospital Medical Center, Cincinnati

People needed

100

Starts

2020-10-02

Expected to finish

2026-08-31

Last updated by the study team

2026-08-10

Who can join

Age: 6 and older, up to 17. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Stated willingness to comply with all study procedures and availability for the duration of the study.
• Male or female, between the ages of 6.00-17.99 years at the time of consent.
• Able to take oral (liquid) medication.
• English is primary language.
• Meets criteria for ADHD (hyperactivity, inattention, or combined) on the KSADS
• Meets criteria for ADHD (hyperactivity, inattention, or combined) on the Vanderbilt (historically or currently, as indicated by a teacher/professional)

You may not qualify if…

• Current use of ADHD stimulant or non-stimulant medication and unwilling to discontinue for >/= 3 days prior to starting the study.
• Children with psychoses or bipolar disorder based on diagnostic interview with the parent.
• Organic Brain Injury: Children must not have a history of head trauma with loss of consciousness, epilepsy, or any other organic disorder that could possibly affect brain function.
• Specific heart conditions including the following:
• QTc on baseline ECG>470ms or QTC > 500 in patients with repaired CHD, as determined by ECG
• Brugada pattern, as determined by ECG
• Baseline heart rate or systolic blood pressure > 2 SD above mean for age as determined by medical examination.
• 2nd or 3rd degree AV block, as determined by ECG
• History of aborted sudden cardiac death or unexplained syncope as determined by medical history
• History of a single ventricle as determined by medical history
• Valvular regurgitation or stenosis > mild, as determined by ECHO
• Moderate or greater ventricular dysfunction, as determined by ECHO
• Pulmonary hypertension, defined as right ventricular pressure >33% systemic pressure or septal position consistent with >mild right ventricular hypertension, as determined by ECHO
• Use of a pacemaker as determined by medical history
• Wolff Parkinson White/pre-ventricular excitation, as determined by ECG
• Atrial, junctional, or ventricular tachyarrhythmia, as determined by ECG
• Frequent premature ventricular contractions (PVCs) or premature atrial contractions (PACs), as determined by ECG
• Abnormal T waves with inversion in V5 and/or V6, bizarre T wave morphology, notched biphasic T waves, or ST segment depression suggesting ischemia or inflammation, as determined by ECG
• Moderate or larger atrial septal defect, as determined by ECHO
• Ventricular septal defect > small by ECHO
• Valvar stenosis > mild by ECHO
• Aortic root dilation > 2SD above mean by ECHO.
• If participants meet any of the following heart conditions, they must be evaluated for the study by a cardiologist before beginning:
• Right ventricular enlargement/right axis deviation, as determined by ECG
• Intraventricular conduction delay >120ms in child >12 years old or >100ms in child <8 years old, as determined by ECG

Where it is running

• 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

Full record on ClinicalTrials.gov

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