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Can a common ADHD drug help kids with down syndrome?

NCT ID NCT04219280

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 10, 2026 · Last updated Aug 11, 2026 · Updated 1 time

Summary

This trial investigates whether a long-acting liquid stimulant medication (Quillivant XR) can safely and effectively reduce ADHD symptoms in children with Down syndrome, who are at higher risk for ADHD but often go untreated. The study will compare the medication against a placebo in about 100 children aged 6 to 17. Researchers will measure changes in ADHD symptoms, emotional regulation, and behavior using parent and teacher reports.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Quillivant XR (a long-acting liquid stimulant medication)
What this could lead to
If effective, this could provide evidence that stimulant medication is a safe and useful option for managing ADHD in children with Down syndrome, potentially improving their daily functioning and quality of life.
What could go wrong
This is an early-stage trial in a specific population, and results may not apply to all children. Stimulant medications can have side effects, and the trial's success is not guaranteed.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2020

Expected to finish

Aug 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

6 to 17 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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).

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Boston Children's Hospital

    Boston, Massachusetts, 02115, United States

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio, 45229, United States

  • University of California Davis MIND Institute

    Sacramento, California, 95817, United States

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15203, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.