Identification of Neural Markers of Aggression and Irritability and Their Capacity to Predict Treatment Response to CNS Stimulant Medication in Youth With ADHD

What this Trial Is About

Researchers are studying children with ADHD who also have high levels of impulsive aggression and chronic irritability (IACI), which are common reasons for behavioral health care. This study aims to understand how brain responses measured by event-related potentials (ERPs) relate to changes in IACI when children take central nervous system (CNS) stimulant medications. The goal is to predict which children will improve with these medications by examining brain activity during reward and attention tasks. The study involves 136 children aged 8 to 12 with ADHD and elevated IACI. It starts with a six-week open-label phase where each child's dose of an FDA-approved CNS stimulant is carefully adjusted for optimal effect. After this, there is a two-week double-blind crossover phase where each child receives their optimized stimulant dose for one week and a placebo for one week, in random order. During the crossover phase, brain activity is recorded using EEG while children complete tasks related to learning and attention. Participants and their guardians will take part in multiple assessments throughout the study including daily ratings of symptoms at home, weekly clinical interviews, and teacher reports. Brain activity will be measured twice during the crossover phase. The study collects data on irritability, aggression, ADHD symptoms, medication effects, side effects, and functional impairment. The total participation lasts up to about 12 weeks, including dose optimization and the crossover trial, with ongoing monitoring to understand treatment responses and safety.

Predictors of Improvements in Irritability and Aggression in Children With ADHD Treated With CNS Stimulants