ADHD - Attention Deficit Disorder With Hyperactivity study: CNS Stimulant
Official title Predictors of Improvements in Irritability and Aggression in Children With ADHD Treated With CNS Stimulants
ClinicalTrials.gov ID: NCT06871488
What this study is testing
What is CNS Stimulant?
An investigational drug being studied for ADHD with hyperactivity and impulsive aggression.
Also referred to as CNS Simulant RCT phase (second phase).
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study wants to find out if certain brain responses measured with EEG can tell which kids will get better irritability and aggression when their stimulant dose is optimized.
- Who it's for
- Children with ADHD who also have high levels of irritability and aggression.
- What's involved
- Participants will have their stimulant dose adjusted over six weeks, then take part in a two‑week period where they receive either the optimal dose or a placebo in a blinded crossover. During each week they will have EEG tests, do simple tasks, and parents will record the child’s irritability three times a day.
- Time commitment
- The study lasts about eight weeks in total: six weeks for dose adjustment and two weeks for the crossover trial, with several clinic visits and daily parent reports.
- Phase 4: studies an already-approved treatment
- Time commitment: about 6 weeks
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 7 to 12
You may be able to join if
- Meet criteria for any presentation of ADHD
- Moderate or worse impairment related to ADHD
- Elevated levels of irritability and/or aggression on guardian ratings of Affective Reactivity Index and Retrospective Modified Overt Aggression Scale
- fluent in English for child and guardian
- Guardian and child are willing to have child take CNS stimulant medication for ADHD
You likely can't join if
- Medical contraindications to use of CNS stimulants
- Autism Spectrum Disorder,
- Bipolar Disorder,
- Intellectual/Developmental Delay
- current use of antipsychotic, mood stabilizing
- Use of other medications that impact EEG data collection (e.g. benzodiazepenes)
See the full eligibility criteria
- Meet criteria for any presentation of ADHD
- Moderate or worse impairment related to ADHD
- Elevated levels of irritability and/or aggression on guardian ratings of Affective Reactivity Index and Retrospective Modified Overt Aggression Scale
- fluent in English for child and guardian
- Guardian and child are willing to have child take CNS stimulant medication for ADHD
- Medical contraindications to use of CNS stimulants
- Autism Spectrum Disorder,
- Bipolar Disorder,
- Intellectual/Developmental Delay
- current use of antipsychotic, mood stabilizing
- Use of other medications that impact EEG data collection (e.g. benzodiazepenes)
- hearing or visual deficits that impede ability to do computer tasks
- Current Major Depressive Episode
- Current suicidal ideation
- child has failed two fully optimized trials of methylphenidate products AND two for amphetamine products
The study team makes the final eligibility decision.
Where it is enrolling
- Hershey, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The study runs about 6 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 7 years to 12 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Hershey, Pennsylvania, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.