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

Launched by MILTON S. HERSHEY MEDICAL CENTER · Mar 7, 2025

Keywords

ClinConnect Summary

This clinical trial is studying how certain brain responses can help predict changes in irritability and aggression in children with Attention Deficit Hyperactivity Disorder (ADHD) who are treated with stimulant medications. Many children with ADHD also struggle with impulsive aggression and irritability, which can lead to them needing more intensive treatments. The researchers want to see if measuring specific brain activity, using a method called event-related potentials (ERPs), can help identify which children are likely to benefit from stimulant medications the most.

To be eligible for this study, children must be between 6 and 12 years old, have a diagnosis of ADHD, and show moderate or higher levels of irritability and aggression. They also need to be fluent in English, and their guardians must agree to their participation in taking stimulant medication. Over a six-week period, participants will have their medication dosage adjusted, followed by a two-week period where they will alternate between taking the medication and a placebo (a pill without the active drug). Throughout the study, parents will provide feedback several times a day about their child’s behavior to help capture how well the medication is working. This trial is not yet recruiting participants, but it aims to improve treatment strategies for children with ADHD and behavioral challenges.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Meet criteria for any presentation of ADHD
• • 2. Moderate or worse impairment related to ADHD
• • 3. Elevated levels of irritability and/or aggression on guardian ratings of Affective
• • 4. Reactivity Index and Retrospective Modified Overt Aggression Scale
• • 5. fluent in English for child and guardian
• • 6. Guardian and child are willing to have child take CNS stimulant medication for ADHD
• Exclusion Criteria:
• • 1. Medical contraindications to use of CNS stimulants
• • 2. Autism Spectrum Disorder,
• • 3. Bipolar Disorder,
• • 4. Intellectual/Developmental Delay
• • 5. current use of antipsychotic, mood stabilizing
• • 6. Use of other medications that impact EEG data collection (e.g. benzodiazepenes)
• • 7. hearing or visual deficits that impede ability to do computer tasks
• • 8. Current Major Depressive Episode
• • 9. Current suicidal ideation
• • 10. child has failed two fully optimized trials of methylphenidate products AND amphetamine products