The Effects of ADHD Medication (TEAM) Study (NCT02293655) | Clinical Trial Compass
CompletedPhase 4
The Effects of ADHD Medication (TEAM) Study
United States204 participantsStarted 2015-01-12
Plain-language 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.
Who can participate
Age range7 Years – 11 Years
SexALL
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Inclusion criteria
✓. ADHD Diagnostic Status: Meets DSM-V criteria for ADHD, with Clinical Global Impression (CGI) rating corresponding to at least "moderately ill."
✓. 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
✓. 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
✕. Psychiatric Medications: Current or prior use of any medication for psychological/psychiatric problems
✕. Behavioral Interventions: Current active participation in ADHD-related behavioral interventions, given that improvements due to these interventions may confound our group comparisons
✕. 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
✕. 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
✕. 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
What they're measuring
1
Parent ADHD Total Symptom Scores
Timeframe: baseline, study weeks 8, 9, 10, 12
2
Inhibitory Control Reaction Time Variability (SD of the Reaction Time)
Timeframe: baseline, study weeks 8, 9, 10 & 12
3
Math Computation - Number of Problems Completed Correctly
Timeframe: baseline, study weeks 8, 9, 10 & 12
4
% Time on Task
Timeframe: baseline, study weeks 8, 9, 10, 12
Trial details
NCT IDNCT02293655
SponsorChildren's Hospital Medical Center, Cincinnati