Treatment of ADHD in children with Down syndrome

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

This study tests if a medication called methylphenidate can help children with Down syndrome and ADHD feel better and improve their focus.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 6 Years to 17 Years
• Sex: All
• Sponsor: Children's Hospital Medical Center, Cincinnati (other)
• Locations: 4 sites (Sacramento, California and 3 other locations)
• Trial ID: NCT04219280 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the efficacy and safety of stimulant medication, specifically methylphenidate, in children diagnosed with both Down syndrome and ADHD. The study will involve 100 participants aged 6 to 17 years, who will undergo a series of assessments to determine their eligibility and monitor their progress throughout the treatment. Participants will receive either the medication or a placebo, with careful titration of the dosage based on their individual needs and health assessments conducted biweekly. The trial aims to provide critical data on the short- and long-term effects of stimulant treatment in this unique population.

Who should consider this trial

Good fit: Ideal candidates are children aged 6 to 17 years with a diagnosis of both Down syndrome and ADHD.

Not a fit: Patients currently using ADHD medications or those with specific heart conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this trial could significantly improve behavioral and cognitive outcomes for children with Down syndrome and ADHD.

How similar studies have performed: While stimulant use in ADHD is well-established, this specific approach for children with Down syndrome is novel and has not been extensively tested.

Eligibility criteria

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).

Where this trial is running

Sacramento, California and 3 other locations

• University of California Davis MIND Institute — Sacramento, California, United States (COMPLETED)
• Boston Children's Hospital — Boston, Massachusetts, United States (RECRUITING)
• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States (RECRUITING)
• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States (RECRUITING)

Study contacts

• Principal investigator: Anna Esbensen, PhD — Children's Hospital Medical Center, Cincinnati
• Study coordinator: Emily K Hoffman, MEd

Conditions: Down Syndrome, ADHD