ADHD
Conditions
Keywords
ADHD, side effects, sleep, dopamine, pharmacogenetics
Brief summary
Children between 6-17 are evaluated for ADHD and and a blood sample is obtained for DNA extraction. If eligible, they participate in a 4 week, double blind, placebo controlled trial with weekly switches. In randomized order, children receive 18, 36, 54 mg. OROS methylphenidate and placebo. Each week, parent report measures, clinical interviews, and safety assessments are conducted. Hypothesis: Efficacy and adverse events will be dose dependent. Dopamine Transporter Genotype will predict response
Interventions
18, 36, 54 mg
Sponsors
National Institute of Mental Health (NIMH)
University of Illinois at Chicago
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* 6-17 DSM IV criteria for ADHD Parents willing to complete measures
Exclusion criteria
* Mental retardation psychoses seizure disorder
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ADHD RS | weekly |
Secondary
| Measure | Time frame |
|---|---|
| CGI-S | weekly |
| VItal Signs | weekly |
| Sleep Questionnaire | weekly |
| Side Effects rating Scale | weekly |
Countries
United States
Outcome results
None listed