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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 4INTERVENTIONAL

Evaluating Treatment of ADHD in Children with Down Syndrome

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

Evaluating Treatment of ADHD in Children with Down Syndrome (NCT04219280) is a Phase 4 interventional studying Down Syndrome and ADHD, sponsored by Children's Hospital Medical Center, Cincinnati. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

What Stage of Research Is This?

Phase 4 studies happen after a treatment has been approved by the FDA. They monitor long-term safety, real-world effectiveness, and any rare side effects that only emerge in larger populations over longer periods. Phase 4 results sometimes lead to label changes, additional warnings, or — rarely — withdrawal of approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 100 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Down Syndrome subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: - 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) Who Should NOT Join This Trial: - 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: 1. QTc on baseline ECG\>470ms or QTC \> 500 in patients with repaired CHD, as determined by ECG 2. Brugada pattern, as determined by ECG 3. Baseline heart rate or systolic blood pressure \> 2 SD above mean for age as determined by medical examination. 4. 2nd or 3rd degree AV block, as determined by ECG 5. History of aborted sudden cardiac death or unexplained syncope as determined by medical history 6. History of a single ventricle as determined by medical history 7. Valvular regurgitation or stenosis \> mild, as determined by ECHO 8. Moderate or greater ventricular dysfunction, as determined by ECHO 9. Pulmonary hypertension, defined as right ventricular pressure \>33% systemic pressure or septal position consistent with \>mild right ventricular hypertension, as determined by ECHO 10. Use of a pacemaker as determined by medical history 11. Wolff Parkinson White/pre-ventricular excitation, as determined by ECG ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * 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) Exclusion Criteria: * 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: 1. QTc on baseline ECG\>470ms or QTC \> 500 in patients with repaired CHD, as determined by ECG 2. Brugada pattern, as determined by ECG 3. Baseline heart rate or systolic blood pressure \> 2 SD above mean for age as determined by medical examination. 4. 2nd or 3rd degree AV block, as determined by ECG 5. History of aborted sudden cardiac death or unexplained syncope as determined by medical history 6. History of a single ventricle as determined by medical history 7. Valvular regurgitation or stenosis \> mild, as determined by ECHO 8. Moderate or greater ventricular dysfunction, as determined by ECHO 9. Pulmonary hypertension, defined as right ventricular pressure \>33% systemic pressure or septal position consistent with \>mild right ventricular hypertension, as determined by ECHO 10. Use of a pacemaker as determined by medical history 11. Wolff Parkinson White/pre-ventricular excitation, as determined by ECG 12. Atrial, junctional, or ventricular tachyarrhythmia, as determined by ECG 13. Frequent premature ventricular contractions (PVCs) or premature atrial contractions (PACs), as determined by ECG 14. 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 15. Moderate or larger atrial septal defect, as determined by ECHO 16. Ventricular septal defect \> small by ECHO 17. Valvar stenosis \> mild by ECHO 18. 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: 1. Right ventricular enlargement/right axis deviation, as determined by ECG 2. Intraventricular conduction delay \>120ms in child \>12 years old or \>100ms in child \<8 years old, as determined by ECG 3. Right or left bundle branch block, as determined by ECG * Treatment with a monoamine oxidase inhibitor (MAOI) or use of an MAOI within 14 days. * Active titration of non-ADHD, non-MAO psychotropic medication. Stable use of non-ADHD, non-MAO psychotropic medication, defined by no dose changes for \>/= 4 weeks before starting the study medication trial, will be allowed. * Known hypersensitivity or allergic reactions to methylphenidate or product components such as banana (due to bananas serving as flavoring in the formulation of the project's study interventions - Quillivant XR and the placebo). * Severe Obstructive Sleep Apnea (OSA) as rated by McGill index of 4 * Pregnancy. (Since there is limited information regarding the safety of Quillivant XR during pregnancy, a pregnancy test will be conducted at the medical screen for female participants who have commenced the menstrual cycle. If pregnancy is indicated, the participant will be excluded from the study as a precautionary measure).

Treatments Being Tested

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)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

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

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT04219280), the sponsor (Children's Hospital Medical Center, Cincinnati), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT04219280 clinical trial studying?

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 evidenc… The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT04219280?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT04219280?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT04219280. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT04219280. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.