Faraone 2007a.
Methods | A long term, open‐label, longitudinal study of methylphenidate use for up to 37 months | |
Participants | Number of participants screened: 268 Number of participants included: 191 Number of participants followed up: 127 Number of withdrawals: 64 Diagnosis of ADHD: DSM‐IV (subtype: not stated) Age: range 6‐12 years old IQ: not stated Sex: not stated Methylphenidate‐naïve: not stated Ethnicity: not stated Country: USA Comorbidity: not stated Comedication: not stated Sociodemographics: not stated Inclusion criteria
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Interventions | Methylphenidate type: transdermal system Methylphenidate dosage: 6.25 cm2 (0.5 mg/hour) to 50 cm2 (3.6 mg/hour) Administration schedule: 12 hour wear time Duration of intervention: 37 months Treatment compliance: not stated |
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Outcomes | Non‐serious adverse events: Weight, height and BMI, values were converted to age‐corrected standard scores (z scores) and percentiles using the normative growth charts and transformations provided by the Centers for Disease Control and Prevention | |
Notes | Sample calculation: not stated Ethics approval: the study was approved by each site's local institutional review board or by a central IRB Funding/vested interests: this study was supported in part by a grant from Shire Pharmaceutical Development to SF Authors' affiliations: Dr Faraone receives research support from McNeil Consumer & Specialty Pharmaceuticals, Shire US, and Eli Lilly; is on the speakers' bureaus of Eli Lilly, McNeil Consumer & Specialty Pharmaceuticals, Shire US, and Cephalon; and has had an advisory or consulting relationship with the McNeil Consumer & Specialty Pharmaceuticals, Noven Pharmaceuticals, Shire US, Cephalon, and Eli Lilly. Mr Giefer has no financial relationships to disclose Key conclusions of the study authors: methylphenidate transdermal system treatment is associated with growth deficits in both weight, height, and BMI, but growth deficits attenuate over time. Baseline growth influences the effect of MTS treatment on both height, weight, and BMI, whereas prior stimulant therapy, dose, and total time treated influences only weight and BMI Comments from the study authors: prior stimulant therapy predicted smaller weight and BMI (but not height) deficits during the course of treatment with MTS. Growth velocity analyses showed that the rates of weight and BMI increases were negative in the first year of the study but positive at later time points. These findings suggest that any adverse effects of MTS on weight or BMI occur near the commencement of treatment and show some attenuation over time Exclusion of methylphenidate non‐responders/children who have previously experienced adverse events on methylphenidate: not stated |