Evaluating Treatment of ADHD in Children With Down Syndrome

• Status: Recruiting
• Trial end date: 2022-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

Therefore, the investigators propose a pilot clinical trial to support the first randomized clinical trial of stimulant medication in children with DS+ADHD. The purpose of this study is to inform sample size estimates for the larger clinical trial. 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. Further, children will take part in the pilot methylphenidate clinical trial to inform measures retained and desired sample size for the future clinical trial.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Children's Hospital Medical Center, Cincinnati
• Collaborator: University of California, Davis
• Treatments: Methylphenidate

Criteria

Inclusion Criteria:

• Documented diagnosis of DS through genetic testing

• Ages 6.00-17.99 years

• English is primary language

• Meet criteria for ADHD on the KSADS

• Meet criteria for ADHD on Vanderbilt (historically or currently)

Exclusion Criteria:

• 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; (4) Complete 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) moderate or greater AV valve regurgitation as determined by ECHO; (8) moderate or greater ventricular dysfunction as determined by ECHO; (9) Pulmonary hypertension, defined as a mean pulmonary arterial pressure or right ventricular pressure without right ventricular outflow tract obstruction >25mmHg by ECHO; (10) Use of a pacemaker (11); Wolff Parkinson White/preventricular excitation, as determined by ECG; (12) Right ventricular enlargement/right axis deviation, as determined by ECG; (13) Intraventricular conduction delay >120ms in child >12 years old or >100ms in child < 8 years old, as determined by ECG in individuals with no prior history of cardiac surgery; (14) Right or left bundle branch block as determined by ECG; (15) Atrial, junctional, or ventricular tachyarrhythmia as determined by ECG; (16) Frequent premature ventricular contractions or premature atrial contractions as determined by ECG; (17) 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; . This can be verified in the participant's EPIC EMR.

• Children with psychoses or bipolar disorder based on diagnostic interview with the parent.

• Nonverbal mental age less than 36 months (3 years) per parent report.

• 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.

• Treatment with a monoamine oxidase inhibitor (MAOI) or use of an MAOI within 14 days.

• Known hypersensitivity or allergic reactions to methylphenidate or product components such as bananas (due to bananas serving as an active ingredient in the formulation of the project's study intervention - Quillivant XR).

• 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's parent/guardian will be notified, and the participants will be excluded from the study as a precautionary measure.

• Moderate or severe obstructive sleep apnea (OSA) as rated by McGill index of 3 or higher.

• Current use of ADHD stimulant or non-stimulant medications.