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New treatment option for ADHD - Attention Deficit Disorder With Hyperactivity
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?
CNS Stimulant is an investigational medicine, given as an once-weekly pill taken by mouth, being studied as a potential treatment for adhd - attention deficit disorder with hyperactivity.
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
- 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.
- 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's taking place
- Hershey, Pennsylvania, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 - 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?
Study sites include Hershey, Pennsylvania, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.