Winsberg 1982.
Methods | A non‐randomised, double‐blind cross‐over trial with fixed doses of methylphenidate given twice a day for a week each in the following schedule:
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Participants | Number of participants screened: not stated Number of participants included: 25 Participants were administered successive 5 1‐week treatment conditions of fixed oral dose given twice daily Number of participants followed up: 20 Number of withdrawals: 5 Diagnosis of ADHD: DSM‐III (subtype: not stated) Age: mean 9.27, range 6.7‐12.1 IQ: mean 98.2 (14.2) Sex: 25 males Methylphenidate‐naïve: not stated Ethnicity: not stated Country: USA Comorbidity: not stated Comedication: not stated Sociodemographics: not stated Inclusion criteria
Exclusion criteria
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Interventions | Participants were administered successive 5 1‐week treatment conditions of fixed oral doses given twice daily according to the following order: placebo 1; 0.25 mg/kg; 0.50 mg/kg; 1.00 mg/kg; placebo 2 Methylphenidate type: not stated Duration of intervention: 5 weeks Washout: not stated Titration period: none Treatment compliance: not stated |
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Outcomes |
Non‐serious adverse events: Treatment‐emergent side effects, weight, blood pressure measured at the end of each treatment period (after 1 week intervention). Blood pressures were obtained 2 hours following the administration of the oral dose |
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Notes | Sample calculation: not stated Ethics approval: not stated Funding/vested interests/authors' affiliations: not stated Key conclusions from study authors: teacher and parents ratings showed increased improvement in social behaviour as a function of methylphenidate dose. No drug effects were obtained on cognitive performance. Methylpenidate plasma concentrations were significantly associated with oral dose and with measures of social behaviour. No relationship was found with cognitive behaviour. Side effects at the largest dose were severe enough to require discontinuation of treatment for 5 children, but were relatively mild for the rest of the children Supplemental information requested through personal email correspondence with authors in September 2013. Not able to get supplemental information regarding data on side effects, and therefore we cannot use the data in the meta‐analyses but only report them as part of a weighted mean (Hungund 2013 [pers comm]) |