Evaluating Treatment of ADHD in Children with Down Syndrome
This study is looking at how well Quillivant XR, a liquid medication, works to treat Attention Deficit Hyperactivity Disorder (ADHD) in children with Down Syndrome. Researchers will compare Quillivant XR to a placebo (a liquid that looks and tastes the same but has no medicine). The study aims to see if Quillivant XR can improve ADHD symptoms and emotion regulation, as reported by parents and teachers. They also want to check the safety of the medication, especially for the heart. Children aged 6 to 17 years old with Down Syndrome and ADHD who can take liquid medicine and whose primary language is English may be able to join. The study plans to enroll 100 participants.
- Study design
- This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 100 children.
- What's involved
- Participants will have 13 different assessment visits, including a baseline visit and visits during medication titration. Diagnostic and health assessments will be conducted bi-weekly during the initial medication phase.
- Compensation
- Not stated in the trial record.
- Follow-up
- ADHD symptoms and emotion regulation will be measured at various points up to Week 30.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Evaluating Treatment of ADHD in Children With Down Syndrome
At a glance
Conditions
Where it's being run
4 sites across 4 statesStudy leadership
- Anna Esbensen, PhD · PRINCIPAL_INVESTIGATOR · Children's Hospital Medical Center, Cincinnati
- Tanya Froehlich, MD · PRINCIPAL_INVESTIGATOR · Children's Hospital Medical Center, Cincinnati
- Kathleen Angkustsiri, MD · PRINCIPAL_INVESTIGATOR · University of California Davis MIND Institute
- Benjamin Handen, MD · PRINCIPAL_INVESTIGATOR · University of Pittsburgh Medical Center
- Sabrina Sargado, MD · PRINCIPAL_INVESTIGATOR · Boston Children's Hospital
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
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Inclusion
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What this trial measures
- Mean magnitude of change in ADHD Symptoms as measured by parent and teacher report on the Vanderbilt ADHD Parent and Teacher Rating Scales, compared to placebo, during the optimal MPH dosage period. [ Time Frame: Phase 2, Phase 3 ]Baseline, Weeks 2-14, Weeks 18, 22, 26, and 30
A 49-item parent-report measure used to assess parent and teacher perceptions of youth's school and social functioning. The first 47 items assess symptoms of inattention, hyperactivity, combined inattention and hyperactivity, oppositional-defiant disorder, conduct disorder, and anxiety/depression. These items are scored on a 0-3 scale (0 = Never; 1 = Occasionally; 2 = Often; 3 = Very Often). The next two items measure impairment in performance and are scored on a 1-5 scale (1 = Above Average; 3 = Average; 5 = Problematic). For both sub-scales, lower scores mean better outcomes. Data will be entered into SPSS and used as a diagnostic outcome measure.
- Mean magnitude of change in Emotion Regulation as measured by parent and teacher report on the BRIEF2, compared to placebo, during the optimal MPH dosage period. [ Time Frame: Phase 2, Phase 3 ]Baseline, Week 12, Week 14, and Week 30
A 63-item parent and teacher rating scale used to assess everyday skills measuring executive functioning, including inhibition, shifting attention, emotional control, initiating tasks, problem solving, working memory, and monitoring activities. All 63-items are scored on a 3-item scale (N = never, S = Sometimes, O = Often). Scoring is performed through a software which generates T-scores for 13 sub-scales, with borderline and clinical ranges identified. Lower scores on this measure indicate better outcomes. Data will be entered into SPSS and used as a behavioral outcome measure.