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NCT06871488 · ClinicalTrials.gov registry record · Phase 4
Predictors of Improvements in Irritability and Aggression in Children With ADHD Treated With CNS Stimulants
A Phase 4 study of ADHD - Attention Deficit Disorder With Hyperactivity and Irritability, sponsored by Milton S. Hershey Medical Center.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 136
- Enrollment target
- 1
- Study location
NCT06871488 is a Phase 4 study of ADHD - Attention Deficit Disorder With Hyperactivity and Irritability that is actively recruiting participants, run by Milton S. Hershey Medical Center. The registered enrollment target is 136 participants, above the 105-participant average among 3 other ADHD - Attention Deficit Disorder With Hyperactivity trials with a reported enrollment target (30% higher). The trial reports 1 study location across 1 state.
The verdict
NCT06871488, a Phase 4 study of ADHD - Attention Deficit Disorder With Hyperactivity and Irritability, is actively recruiting participants, sponsored by Milton S. Hershey Medical Center.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 136 participants
- Enrollment target
- 1
- Study location
Study Summary
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 predictors. Youth with ADHD and IACI struggle with multiple aspects reinforcement learning (RL), defined as learning from interactions with the environment to reach a goal. Successful RL efforts tap multiple cognitive functions. In controlled laboratory tasks, youth with IACI and various BH disorders exhibit excessive behavioral and neural response to receiving reward (reward responsiveness), difficulty processing environmental cues to adapt behavior to meet a goal (set shifting/goal updating) and impaired ability to flexibly attend to relevant stimuli when blocked from a goal (frustrative nonreward). Event related potentials (ERP) are small electrical responses in the brain in response to specific events or stimuli measured by electroencephalogram (EEG) testing. ERPs exist that can serve as established neural measures of each of these cognitive functions offering a child friendly means to assess their contribution to observable levels of IACI. CNS stimulants improve functioning in these specific realms and impact associated ERPs to the degree that differences between ADHD and non-ADH
Conditions Studied
Interventions
- DRUG Placebo
- DRUG CNS Stimulant
- OTHER CNS Stimulant open label first phase
Study Locations (1)
Pennsylvania
- Penn State Health Dept of Psychiatry - Hershey
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 136 participants |
| Start Date | 2026-03-05 |
| Est. Completion | 2030-06-30 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06871488
The ClinicalTrials.gov registry entry for NCT06871488 describes a study currently listed as recruiting, categorized as Phase 4. The registered enrollment target is 136 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 105-participant average among 3 other ADHD - Attention Deficit Disorder With Hyperactivity trials with a reported enrollment target (30% higher). The listed sponsor is Milton S. Hershey Medical Center, which has 396 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with ADHD - Attention Deficit Disorder With Hyperactivity appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT06871488 reports 1 study location spanning 1 distinct geographic area - top geographies include Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT06871488 about?
NCT06871488 is a clinical study titled "Predictors of Improvements in Irritability and Aggression in Children With ADHD Treated With CNS Stimulants". 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 ...
What is the current status of trial NCT06871488?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 136 participants. The study started on 2026-03-05. Estimated completion is 2030-06-30.
What conditions does trial NCT06871488 study?
This clinical trial studies the following conditions: ADHD - Attention Deficit Disorder With Hyperactivity, Irritability, Aggression Childhood.
What interventions are being tested in trial NCT06871488?
The interventions under investigation include: Placebo (DRUG), CNS Stimulant (DRUG), CNS Stimulant open label first phase (OTHER).
Who is sponsoring clinical trial NCT06871488?
This trial is sponsored by Milton S. Hershey Medical Center, which has 396 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06871488 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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