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
Trial Information
Current as of April 23, 2025
Not yet recruiting
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
About Milton S. Hershey Medical Center
Milton S. Hershey Medical Center, a leading academic medical institution affiliated with Penn State University, is dedicated to advancing healthcare through innovative research and clinical trials. With a strong emphasis on patient-centered care, the center leverages its expertise in various medical fields to conduct rigorous clinical studies aimed at improving treatment outcomes and enhancing the understanding of complex health conditions. The facility is committed to ethical research practices and fostering collaboration among multidisciplinary teams, ensuring that participants receive the highest standard of care while contributing to the advancement of medical knowledge.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Hershey, Pennsylvania, United States
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported