What predicts improvement in irritability and aggression in children with ADHD on stimulant medication
Official title: Identification of Neural Markers of Aggression and Irritability and Their Capacity to Predict Treatment Response to CNS Stimulant Medication in Youth With ADHD
Run by Milton S. Hershey Medical Center · NCT06871488 · Data updated 2026-11-12
This study sees if optimizing stimulant medication helps children with ADHD who have high irritability and aggression and whether brain and learning tests can predict who improves.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 7 Years to 12 Years |
| Sex | All |
| Enrollment | 136 (estimated) |
| Sponsor | Milton S. Hershey Medical Center Academic / other |
| Locations | 1 site (Hershey, Pennsylvania) |
| Status | Recruiting |
| Started | March 5, 2026 |
| Main results expected | February 28, 2030 |
| Study ends | June 30, 2030 |
| Registry record updated | April 20, 2026 |
| Trial ID | NCT06871488 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Children with any presentation of ADHD who have moderate or worse impairment and elevated irritability or aggression, who speak English with their guardian, and whose guardian is willing to try stimulant medication are ideal candidates.
✕Probably not a fit
Children with autism spectrum disorder, bipolar disorder, intellectual/developmental delay, current major depressive episode or suicidal ideation, medical contraindications to stimulants, current antipsychotic or mood stabilizer use, or those who have failed fully optimized trials of both methylphenidate and amphetamine products are unlikely to benefit or be eligible.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This trial will enroll 136 children with ADHD and elevated irritability or aggression and use a 6-week open-label dose-optimization phase of CNS stimulants followed by a 2-week within-subject crossover comparing each child’s optimal dose with placebo. Participants complete behavioral reinforcement-learning tasks and EEG recordings (event-related potentials) to measure brain responses related to reward feedback, attention under frustration, and set shifting. Investigators will relate changes in irritability and aggression to these neural and behavioral markers to identify predictors of improvement or risk of worsening. Prior work suggests about 50–60% of children improve with stimulant dose optimization while 5–10% may experience increased irritability or aggression.
Why it matters
Potential benefit: If successful, the results could help clinicians predict which children will benefit from stimulants, reduce unnecessary antipsychotic use, and tailor treatment to avoid worsening symptoms.
How similar studies have gone: Previous research shows dose optimization of stimulants improves irritability in roughly half of affected youth and stimulants alter the same EEG markers, but using EEG and reinforcement-learning measures to predict individual response is a relatively novel approach.
Who can join: the full rules
Show full inclusion / exclusion 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 Reactivity Index and Retrospective Modified Overt Aggression Scale 4. fluent in English for child and guardian 5. 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 two for amphetamine products
Where it's running
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Penn State Health Dept of Psychiatry
Hershey, Pennsylvania, United States Recruiting
Study contacts
- Study coordinator: James G Waxmonsky, MD
- Email: jwaxmonsky@pennstatehealth.psu.edu
- Phone: 1-800-243-1455
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.