Study on CNS Stimulants for Irritability and Aggression in Children with ADHD
This study is looking at how CNS Stimulants affect irritability and aggression in children with Attention Deficit Hyperactivity Disorder (ADHD). Researchers want to understand why some children improve a lot, some only a little, and a small number might even get worse when taking these medications. The study will first find the best dose of a CNS Stimulant for each child (this part is "open-label," meaning everyone knows what they are taking). Then, for two weeks, children will receive either their optimal dose of CNS Stimulant or a placebo (an inactive substance) to compare the effects. This study aims to enroll 136 children aged 7 to 12 who have ADHD, moderate to severe ADHD-related problems, and high levels of irritability and/or aggression. The study is currently unclear on its recruitment status.
- Study design
- This study is interventional and involves 136 participants. It has two phases: an initial open-label phase to find the best dose of CNS Stimulant, followed by a blinded, within-subjects crossover phase comparing the CNS Stimulant to a placebo.
- What's involved
- Participants will have up to 6 visits over a maximum of 12 weeks during the first phase. The second phase involves 14 days of data collection, comparing one week on medication and one week on placebo.
- Compensation
- Not stated in the trial record.
- Follow-up
- Primary outcomes are measured over 14 days during the second treatment phase, and ADHD symptoms are measured over a maximum of 12 weeks during the first phase.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Predictors of Improvements in Irritability and Aggression in Children With ADHD Treated With CNS Stimulants
At a glance
Conditions
Where it's being run
1 sites across 1 statesWho to contact
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What this trial measures
- RCT phase: Guardian rated Affective reactivity Index (ARI)7 days on med and for 7 days on placebo for 14 days of data collection
Thus study examines response markers for CNS stimulants to improve irritability and to improve aggression. For this second treatment phase comprised of the within subjects crossover of optimal med vs placebo, the primary outcome for irritability is the drug placebo difference in the guardian rated Affective Reactivity Index collected for 7 days over the blinded within subjects crossover phase. ARI has 6 items rated 0-2 for range of - to 14 with higher scores representing greater irritability levels. drug placebo difference on this measure will be correlated with drug placebo difference for RewP, P3b and switch positivity ERP
- Open label dose opt: ADHD RS 5 clinician interview6 visits (over a max duration of 12 weeks)
For the first treatment phase (open label dose optimization) the primary outcome is the change in ADHD symptoms as measured by clinician interview using the ADHD RS 5. it has 18 items rates 0-3 with more symptoms reflecting higher scores. will measure change over time with drug;
- RCT phase abridged Revised modified overt aggression scale (RMOAS)7 days on med and 7 days on placebo for 14 days of data collection
The primary rating for aggression is the drug placebo difference in the guardian rated abridged (6 reduced to 6 items) Retrospective Modified Overt Aggression Scale (RMOAS) collected for 7 days over the blinded within subjects crossover phase. The RMOAS abridged version has 6 items rated 0-3 with higher scores equating to greater levels of aggression ; drug placebo difference on this measure will be correlated with drug placebo difference for RewP, P3b and switch positivity ERP