The Effects of ADHD Medication (TEAM) Study
Condition: ADHD
MeSH terms: Attention Deficit Disorder with Hyperactivity
Intervention: OROS-Methylphenidate (MPH)
Intervention description: OROS-methylphenidate will be taken orally once daily at doses that have been approved for the study age group by the U.S. FDA.
Intervention MeSH terms: Methylphenidate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 204.0
Sex: All
Minimum age: 7 Years
Maximum age: 11 Years
Healthy volunteers: No
Keywords: ADHD; inattention; hyperactivity; methylphenidate

Summary:

      This study evaluates the effects of receiving and then discontinuing methylphenidate (MPH) in
      children with ADHD. After receiving MPH for 8 weeks, participants will be randomized to
      either discontinue MPH (and receive placebo) OR remain on MPH for 4 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          1. ADHD Diagnostic Status: Meets DSM-V criteria for ADHD, with Clinical Global Impression
             (CGI) rating corresponding to at least "moderately ill."

          2. Cognitive and Academic Functioning: Intelligence Quotient (IQ) of >80 as estimated by
             Vocabulary and Block Design subtests of the Wechsler Intelligence Scale for
             Children-4th Edition and scaled scores >80 on the Wechsler Individual Achievement
             Test-2nd edition Reading and Math subtests

          3. Physical Health: Physical exam and ECG findings are judged to be normal for age and
             sex by study physician and/or medical consultant, and there is no co-existing
             condition for which MPH is contraindicated 4. School: Enrolled in a school setting
             rather than a home-school program. This ensures that we can obtain parent and teacher
             ratings from separate individuals for diagnosis and outcome assessment

        Exclusion Criteria:

          1. Psychiatric Medications: Current or prior use of any medication for
             psychological/psychiatric problems

          2. Behavioral Interventions: Current active participation in ADHD-related behavioral
             interventions, given that improvements due to these interventions may confound our
             group comparisons

          3. Psychiatric or Neurobehavioral Conditions: Children with mania/hypomania,
             schizophrenia, or severe depressive disorder, as determined by the K-SADS, will be
             excluded since ADHD medications may not be an appropriate first line of treatment for
             children with these comorbid disorders

          4. Organic Brain Injury: History of head trauma, neurological disorder (including
             epilepsy), or other disorder affecting brain function due to potential differences in
             neurophysiology of ADHD phenotype

          5. Cardiovascular Risk Factors: Children with a personal history or family history of
             cardiovascular risk factors will be excluded, or given the option of participating in
             the study after obtaining an EKG and verification from a pediatric cardiologist
             regarding the safety of their participation in a trial of methylphenidate. In this
             case, families will be responsible for the costs of EKG and any necessary cardiologist
             evaluation

          6. Pregnancy: The safety of MPH use during pregnancy has not been established