Large-scale Brain Organization During Cognitive Control in ADHD
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Attention Deficit Disorder with Hyperactivity
Intervention: Methylphenidate; Placebo
Intervention description: A single, low dose of methylphenidate (0.3 mg/kg) will be administered on the drug day.; A matching placebo pill will be administered on the placebo day.
Intervention MeSH terms: Methylphenidate
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Randomized, double-blind, placebo-controlled, crossover design. Each subject with ADHD participates in two sessions, one on drug and one on placebo (order randomized ). Both subjects and experimenters are blind to the order.
Masking: Double (Participant, Investigator)
Masking description: The pharmacy that provides the drug/placebo works from a randomized subject order defining whether each subject received drug first or placebo first. Only the pharmacists know this order, and the drug and placebo look identical to the participants and the investigators.
Enrollment: 37.0
Sex: All
Minimum age: 8 Years
Maximum age: 12 Years
Healthy volunteers: No
Keywords: methylphenidate; functional connectivity; graph theory; cognitive control

Summary:

      The purpose of this study is to test whether children with attention-deficit/hyperactivity
      disorder (ADHD) are impaired in the ability to flexibly adapt brain network organization in
      response to shifting cognitive demands during the exertion of cognitive control, by assessing
      changes in network dynamics resulting from stimulant administration in children with ADHD,
      and how those changes relate to behavioral and symptom improvements. Subjects will be
      children with ADHD aged 8-12. Subjects will participate in multiple testing sessions that
      include: diagnosis and eligibility screening, neuropsychological and behavioral testing, and,
      if eligible, MRI scans and a medication challenge. Children with ADHD who are enrolled in the
      medication challenge will undergo one MRI scan on placebo and one MRI scan on stimulant
      medication, counterbalanced and double-blind. Functional connectivity will be measured using
      functional MRI and innovative graph theoretical analytic tools will be implemented. Network
      metrics will be related to symptomatology and behavioral testing measures. It is hypothesized
      that stimulant administration in children with ADHD will increase flexibility in network
      reconfiguration in response to changing cognitive control demands as compared to when they
      are on placebo. It is further hypothesized that the degree to which brain network
      organization is changed will be related to the degree of improvement in cognitive control
      performance.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Between 8-12 years old

          -  Diagnosis of ADHD (for ADHD group); ADHD group only can have comorbid Diagnostic and
             Statistical Manual of Mental Disorders (DSM-IV) diagnoses of oppositional defiant
             disorder, conduct disorder, depressive disorders, or anxiety disorders

          -  ADHD subjects must never have been treated with medication for their ADHD

        Exclusion Criteria:

          -  Wechsler Intelligence Scale for Children-Fifth Edition Full-Scale Intelligence
             Quotient (IQ) < 80

          -  Wechsler Individual Achievement Test-Third Edition Word Reading < 85

          -  Any neurologic or developmental disabilities

          -  Any reading or learning disabilities

          -  Visual impairment that cannot be corrected-to-normal

          -  Color blindness

          -  Documented hearing impairment greater than 25 decibels (dB) loss in either year

          -  Have already gone through puberty (Tanner Stage II or higher)

          -  Medical contraindication to MRI

          -  Any psychoactive medication