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Biomarker Validation in Motor System Physiology in Attention Deficit Hyperactivity Disorder

NCT ID: NCT04421248
Registry status: Recruiting
Study type: Interventional
Phase: Phase 4
Sponsor: Donald Gilbert, MD, MS, FAAN, FAAP
Conditions: Attention Deficit Hyperactivity Disorder Combined

Overview

ClinicalTrials.gov lists this study as Recruiting.

Official title: Anomalous Motor System Physiology in Attention Deficit Hyperactivity Disorder: Biomarker Validation and Modeling Domains of Function

Enrollment: 214 participants (Estimated).

What is being studied

Intervention: Acids, Carbocyclic
Intervention: Carboxylic Acids
Intervention: Heterocyclic Compounds
Intervention: Heterocyclic Compounds, 1-Ring
Drug: Methylphenidate
Intervention: Methylphenidate
Intervention: Organic Chemicals
Intervention: Phenylacetates
Intervention: Piperidines
Drug: Placebo

Who may be eligible

Ages: 8 Years to 12 Years
Sex: All
Healthy volunteers accepted: Yes

ClinicalTrials.gov lists the following eligibility criteria.

Inclusion Criteria: * 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 Criteria: * 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).

Study locations

2 study locations are listed.

Recruiting site status is explicitly provided for 2 locations; 2 are listed as Recruiting.

Countries: United States

Maryland, United States: 1
Ohio, United States: 1

Sample of listed locations

Kennedy Krieger Institute — Baltimore, Maryland, 21205, United States — Recruiting
Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, 45229, United States — Recruiting

Study details

Start date: September 1, 2020
Primary completion date: February 9, 2026
Completion date: March 1, 2027
First posted: June 9, 2020
Collaborators: Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

Source and update information

Source: ClinicalTrials.gov
NCT ID: NCT04421248
Registry last updated: September 25, 2026
QualifiedStudies registry data refreshed: September 28, 2026
QualifiedStudies record fetched: September 28, 2026

View NCT04421248 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

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