Status:
RECRUITING
Biomarker Validation in Motor System Physiology in Attention Deficit Hyperactivity Disorder
Lead Sponsor:
Donald Gilbert, MD, MS, FAAN, FAAP
Collaborating Sponsors:
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Conditions:
Attention Deficit Hyperactivity Disorder Combined
Eligibility:
All Genders
8-12 years
Phase:
PHASE4
Brief Summary
Attention-Deficit/Hyperactivity Disorder (ADHD) is the most commonly diagnosed neurobehavioral disorder in childhood. Children with ADHD struggle in school due to problems with attention and high leve...
Detailed Description
4.2. NARRATIVE STUDY DESCRIPTION Summary This is a randomized, blinded, placebo-controlled, single-dose crossover study. The objective is to estimate, in a rigorous, unbiased manner, the effect of 10...
Eligibility Criteria
Inclusion
- Either gender, any race, ethnicity or socioeconomic status
- Currently between 8 years 0 months and 12 years, 11 months, 30 days
- Willing to answer questions about ADHD and related diagnoses
- For children with ADHD prescribed stimulant medications, willing to suspend taking medications as specified in the study procedures
- For children with ADHD, willing to participate in the single dose, randomized crossover study to probe acute effects of methylphenidate on biomarkers
- Right hand dominant (predominately right-handed)
- Able to participate in and sign an informed consent
- ADHD inclusion: The diagnosis of ADHD will be based on Diagnostic and Statistical Manual version 5 (DSM-5) criteria using standard rating scales and a structured diagnostic interview. Oppositional Defiant Disorder is permitted; Conduct disorder is excluded.
- Typically Developing (healthy control) inclusion: Free of ADHD or other developmental or psychiatric disorders based on DSM-5 criteria using standard rating scales and a structured diagnostic interview.
Exclusion
- Known diagnosis of mental retardation, cerebral palsy, Autism Spectrum Disorder, traumatic brain injury, brain tumor, epilepsy, or other serious neurological disorder.
- Major Depression, Bipolar Disorder, Conduct Disorder, Adjustment Disorder, other Anxiety Disorders, or other developmental psychiatric diagnoses.
- For females, onset of menses, pregnancy.
- Current use of antidepressants, non-stimulant ADHD medications, dopamine blocking agents, mood stabilizers.
- Implanted brain stimulator, vagal nerve stimulator, ventriculo-peritoneal shunt, cardiac pacemaker, or implanted medication port.
- Diagnosis of a speech/language disorder or a Reading Disability (RD).
Key Trial Info
Start Date :
September 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2026
Estimated Enrollment :
214 Patients enrolled
Trial Details
Trial ID
NCT04421248
Start Date
September 1 2020
End Date
April 1 2026
Last Update
June 19 2025
Active Locations (2)
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1
Kennedy Krieger Institute
Baltimore, Maryland, United States, 21205
2
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229