Evaluating Treatment of ADHD in Children with Down Syndrome
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. 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.
Timeline
- Start
- 2020-10-02
- Primary completion
- 2025-09-30
- Completion
- 2025-09-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Methylphenidate | Small molecule | 7.5 mg | — |
| Comparator | Methylphenidate | Small molecule | 10 mg | — |
| Comparator | Methylphenidate | Small molecule | 15 mg | — |
| Comparator | Methylphenidate | Small molecule | 20 mg | — |
| Comparator | Methylphenidate | Small molecule | 22 mg | — |
| Comparator | Methylphenidate | Small molecule | 22.5 mg | — |
| Comparator | Methylphenidate | Small molecule | 30 mg | — |
| Comparator | Methylphenidate | Small molecule | 34 mg | — |
| Comparator | Methylphenidate | Small molecule | 40 mg | — |
| Comparator | Methylphenidate | Small molecule | 46 mg | — |