Evaluating Assessment and Medication Treatment of ADHD in Children with Down Syndrome using Methylphenidate (Quillivant XR)

What this Trial Is About

Children with Down syndrome (DS) are more likely to have Attention Deficit Hyperactivity Disorder (ADHD) compared to typically developing children, but they are less often treated with stimulant medications despite guidelines recommending their use. This study is the first randomized clinical trial to evaluate stimulant medication treatment in children with DS and ADHD, aiming to determine the benefits and safety of methylphenidate (MPH), especially focusing on cardiac safety. The trial involves 100 children aged 6 to 17 years and addresses behavioral, cognitive, academic, and functional impairments associated with ADHD in this population. Participants will start with a pre-medication assessment to evaluate their baseline cognitive and behavioral status. The trial includes a phase of gradually increasing doses of MPH to find the optimal dose for each child, followed by randomized phases where children receive either the optimal MPH dose or a placebo, then switch to the other treatment. Children who respond well to MPH will enter an open-label phase lasting four months to continue on their optimal dose. Throughout, participants will be closely monitored with regular assessments and safety checks. During the study, children will complete various assessments at multiple visits including intelligence tests, diagnostic evaluations, health exams, and parent and teacher questionnaires. Researchers will monitor ADHD symptoms and emotion regulation changes using standardized rating scales. Safety will be tracked through frequent health assessments, and the final evaluation will review changes in behavior, cognition, and health after 30 weeks. This comprehensive approach aims to understand both the effects and safety of stimulant treatment in children with DS and ADHD.

Evaluating Treatment of ADHD in Children with Down Syndrome