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โ† Trials
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Predictors of Improvements in Irritability and Aggression in Children With ADHD Treated With CNS Stimulants

RecruitingPhase 4Ages 7 Years - 12 YearsAllMilton S. Hershey Medical Center
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In plain words

What the trial is, and whether it could suit you

Impulsive Aggression and chronic irritability (IACI) often occur together and are one of the most common reasons children present for behavioral health (BH) care. ADHD frequently associated with IACI as upwards of 50% of youth with ADHD manifest impairing IACI levels. IACI is the most common reason that children with ADHD are prescribed antipsychotics and admitted to inpatient BH units. Systematic dose optimization of CNS stimulants improves levels of IACI, reducing the need for these more intensive and burdensome treatments. However, response varies, with over half of children with ADHD showing meaningful improvement, upwards of 40% receiving minimal benefit and 3 to 10% exhibiting increased IACI levels. Symptom levels of ADHD or IACI and other demographic variables are of limited utility for predicting response, suggesting the need to move beyond symptoms in the search for treatment pr

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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
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What it tests

  • CNS Stimulant
  • Placebo
  • CNS Stimulant open label first phase
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Where

1 site
Penn State Health Dept of Psychiatry
Hershey, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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