PubMed · 15997863
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Craig Newnes. 2005. Polluting their minds.. https://pubmed.ncbi.nlm.nih.gov/15997863/
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OBJECTIVE: To compare the efficacy and safety of two methylphenidate (MPH) formulations--once-daily modified-release MPH (EqXL, Equasym XL) and twice-daily immediate-release methylphenidate (MPH-IR, Ritalin)--and placebo in children with Attention Deficit/Hyperactivity Disorder (ADHD). METHODS: Children aged 6-12 years on a stable dose of MPH were randomized into a double-blind, three-arm, parallel-group, multi-center study and received 3 weeks of EqXL (20, 40, or 60 mg qd), MPH-IR (10, 20, or 30 mg bid) or placebo. Non-inferiority of EqXL to MPH-IR was assessed by the difference in the inattention/overactivity component of the overall teacher's IOWA Conners' Rating Scale on the last week of treatment (per protocol population). Safety was monitored by adverse events, laboratory parameters, vital signs, physical exam, and a Side Effect Rating Scale. RESULTS: The lower 97.5% confidence interval bound of the difference between MPH groups fell above the non-inferiority margin (-1.5 points) not only during the last week of treatment but during all three treatment weeks. Both MPH-treatment groups experienced superior benefit when compared to placebo during all treatment weeks (P < 0.001). All treatments were well tolerated. CONCLUSIONS: EqXL given once-daily was non-inferior to MPH-IR given twice-daily. Both treatments were superior to placebo in reducing ADHD symptoms.
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One in five U.S. youngsters has a mental disorder, but we know little about the effects of these disorders on child outcomes. We examine U.S. and Canadian children with symptoms of Attention Deficit Hyperactivity Disorder (ADHD), the most common child mental health problem. Our innovations include the use of nationally representative samples of children, the use of questions administered to all children rather than focusing only on diagnosed cases, and the use of sibling fixed effects to control for omitted variables. We find large negative effects on test scores and schooling attainment suggesting that mental health conditions are a more important determinant of average outcomes than physical health conditions.