Study of Genetic Differences in Carboxylesterase 1 and How They Affect Methylphenidate Treatment in Children and Teens with ADHD

What this Trial Is About

Researchers are studying the relationship between genetic differences in the enzyme Carboxylesterase 1 CES1 and how the drug methylphenidate MPH works for children and adolescents with Attention Deficit Hyperactivity Disorder ADHD. MPH is a commonly prescribed stimulant for ADHD, but many patients experience different effects and side effects that are not well understood. This study aims to identify how specific CES1 gene variants affect the way MPH is processed in the body and its therapeutic outcomes. Participants in this study will receive a single dose of methylphenidate, with the exact dose determined by the study team. The focus is on understanding how CES1 genetic variants influence the metabolism of MPH by measuring drug concentrations in the blood over an 8-hour period after dosing. This includes assessing the highest plasma concentration and other pharmacokinetic measures. During the study, participants will undergo blood sampling to monitor methylphenidate levels and related pharmacokinetic outcomes. Researchers will evaluate the maximum plasma concentration of MPH, as well as the time to reach this concentration and the overall drug exposure over time. The study involves youth aged 6 to 17 years diagnosed primarily with ADHD and includes safety monitoring to ensure participant well-being throughout the trial period, which started in 2018 and is expected to finish in 2025.

Carboxylesterase 1 Genetic Variation and Methylphenidate in ADHD