Silva 2004.

Methods	Open‐label cohort study to determine efficacy of a single daily dose of dexmethylphenidate (d‐MPH) in 22 children with ADHD
Participants	Number of participants screened: not stated Number of participants included: 22 Number of participants followed up: 20 Number of withdrawals: not stated Diagnosis of ADHD: DSM‐IV (subtype: not stated) Age: mean 8.7 years old (range 6‐12) IQ: not stated Sex: 17 males, 5 females Methylphenidate‐naïve: n = 18 Ethnicity: white 54%, African American 23%, Hispanic 23% Country: USA Comorbidity: not stated Comedication: not stated Sociodemographics: not stated Inclusion criteria: Children and adolescents aged 6‐18 years with a DSM‐IV diagnosis of ADHD and a CGI severity score which was at least moderate and in otherwise good health Sexually active females were negative for pregnancy screens and using accepted method of contraception Exclusion criteria Contraindication to methylphenidate Allergy Anxiety or agitation Hypertension Glaucoma A seizure or psychiatric disorder Diagnosis or family history of Tourette syndrome Tics Current or past substance abuse Pregnant or lactating females Using MAOIs within previous 30 days Use of other stimulants Any cardiovascular Renal, enterohepatic Respiratory, or immunological disorder Could not communicate with investigator or were unlikely to cooperate with study
Interventions	Methylphenidate type: dexmethylphenidate (d‐MPH) Mean methylphenidate dosage: the starting dose was 2.5 mg/day and titrated to up to a maximum 30 mg/day based on clinical effect and tolerability over 8 weeks. The mean daily dose was 16.0 mg/day Administration schedule: once daily in the morning Duration of treatment: not stated Treatment compliance: was confirmed by tablet and bottle counts
Outcomes	Non‐serious adverse events Participants were seen at least weekly and monitored for adverse events. Apart from nightmares, data were only recorded for adverse events when reported by ≥ 2 participants
Notes	Sample calculation: not stated Ethics approval: approved by Institutional Review Board Funding/vested interest: supported by Celgene Corporation and the NIH Authors' affiliations: New York University, 4 Rivers Clinical Research and Celgene Corporation (4/8 authors) Key conclusions of the study authors: a single daily dose of d‐MPH is safe and effective in controlling ADHD symptoms alleviating the need for midday dosing. Patients who failed prior therapy including dl‐MPH may respond to d‐MPH. A controlled study to confirm these data are warranted Comments from the study authors: in controlled clinical trials, d‐MPH was at least as efficacious and safe as dl‐MPH, at half the dose. In contrast to dl‐MPH it was effective on objective measures 6 hours post‐dose Comments from the review authors: although the only outcome which was measured into the extension period after the 8‐week trial was adverse events, only data up to the end of the 8‐week trial are reported. This study examines the efficacy of d‐MPH, which is not identical to standard methylphenidate (i.e. d‐ and l‐ isomers) Exclusion of methylphenidate non‐responders/children who have previously experienced adverse events on methylphenidate: yes, see exclusion criteria 1 Supplemental information regarding data requested from the authors in April 2014. No reply received