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 is clinical trial of CNS stimulants will enroll 136 youth with ADHD and elevated levels of impulsive aggression and chronic irritability (IACI). It employs a 6 week open label dose optimization trial followed by a 2 week within subjects crossover phase of optimal dose versus placebo. In our preliminary work, the study team observed that about 50 to 60% of children will show moderate or greater improvements in IACI with CNS Stimulants dose optimization. This response appears independent of ADHD symptom change. Across studies, 5 to 10% of youth with ADHD experience increased IACI, but th...

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