Actively Recruiting
Evaluating Treatment of ADHD in Children with Down Syndrome
Led by Children's Hospital Medical Center, Cincinnati · Updated on 2025-01-15
100
Participants Needed
4
Research Sites
260 weeks
Total Duration
On this page
Sponsors
C
Children's Hospital Medical Center, Cincinnati
Lead Sponsor
U
University of California, Davis
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Evaluating Treatment of ADHD in Children with Down Syndrome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willingness to comply with all study procedures and available for the entire study duration
- Male or female between 6.00 and 17.99 years old at consent
- Able to take oral (liquid) medication
- English is the primary language
- Meets ADHD criteria on the KSADS
- Meets ADHD criteria on the Vanderbilt scale (historically or currently) based on teacher/professional report
You will not qualify if you...
- Current use of ADHD stimulant or non-stimulant medication and unwilling to stop for at least 3 days before the study
- Diagnosis of psychoses or bipolar disorder
- History of head trauma with loss of consciousness, epilepsy, or other organic brain disorders
- Specific heart conditions including abnormal ECG or echocardiogram findings such as prolonged QTc, Brugada pattern, high heart rate or blood pressure, AV block, significant valvular disease, ventricular dysfunction, pulmonary hypertension, pacemaker use, arrhythmias, or congenital heart defects
- Certain heart conditions requiring cardiologist evaluation before starting
- Use of monoamine oxidase inhibitors (MAOI) currently or within 14 days
- Active changes in non-ADHD psychotropic medication doses within 4 weeks before the trial
- Allergic reactions to methylphenidate or formulation components like banana flavoring
- Severe obstructive sleep apnea
- Pregnancy confirmed by test for females who have started menstruation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
University of California Davis MIND Institute
Sacramento, California, United States, 95817
Completed
2
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
3
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Actively Recruiting
4
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15203
Actively Recruiting
Research Team
E
Emily K Hoffman, MEd
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
FACTORIAL
Primary Purpose
TREATMENT
Number of Arms
2
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