Wigal 2011.

Methods	A double blind, double‐dummy randomised cross‐over study with osmotic release oral system (OROS) methylphenidate and immediate release methylphenidate given with 5 different breakfast conditions
Participants	Number of participants screened: not stated Number of participants included: 32 Participants were randomly assigned to 1 of 6 possible drug condition orders Number of participants followed up: 30 Number of withdrawals: 1 Diagnosis of ADHD: DSM (subtype: not stated) Age: mean 10.1 (SD 1.5), range 7‐12 years old IQ: not stated Sex: 26 males, 5 females Methylphenidate‐naïve: none Ethnicity: white: 67.7%, African American: 1%, Hispanic: 3%, others: 6% Comorbidity: not stated Comedication: none Sociodemographics: not stated Inclusion criteria Methylphenidate treatment for at least 3 months previously at dose = 5‐20 mg IR methylphenidate twice daily or SR methylphenidate 20 mg‐60 mg daily On a stable methylphenidate dose for ≥ 4 weeks before enrolment Known to be positive responders No treatment for methylphenidate related insomnia, anticonvulsants or any 'investigational' treatments for 4 weeks prior to study No medication affecting CNS of blood pressure in any way, for 7 days before study No changes in methylphenidate medication for 7 days before start of study Exclusion criteria Any clinical condition that would interfere with the conduct of the study Any gastrointestinal conditions, marked anxiety, tension, agitation, depression, psychosis, seizures, Tourette Hypertension (mean of 2 BP measurements > 95th percentile for age, sex or height) Patients in whom the primary focus of treatment ODD, CD, tics or mood disorders
Interventions	Participants were randomly assigned to 1 of 5 possible drug condition orders of equivalent to OROS MPH 18 mg, 36 mg and 54 mg and IR MPH 5 mg, 10 mg and 15 mg based on pre‐study established doses. Group 1 OROS methylphenidate once a day after high‐fat breakfast OROS methylphenidate once a day in fasting state IR methylphenidate 3 times daily in fasting state Group 2 OROS methylphenidate once a day after high‐fat breakfast OROS methylphenidate once a day after normal breakfast OROS methylphenidate 3 times daily, 1st dose after normal breakfast Mean MPH dosage: not stated. Administration schedule: not stated. Duration of each medication condition: not stated. Washout prior to study initiation: not stated. Medication‐free period between intervention: not stated. Titration period: not stated Treatment compliance: not stated
Outcomes	Non‐serious adverse events Vital signs measured pre‐dose, then every 1.5‐2.5 h until 11.5 h postdose
Notes	Sample calculation: not stated Ethics approval: not stated, but UC Irvine Institutional Review Board approved consent procedures Funding/vested interest/authors' affiliations: Sharon Wigal on a number of drug company advisory boards. Suneel Gupta is a full‐time employee of Impax Pharmaceuticals and previously worked for a number of drug companies. Lynne Starr and Erica Everin are employees of a drug company. The study was sponsored by ALZA corporation. Ortho‐McNeil Janssen Scientific Affairs funded an editorial on the study Key conclusions of the study authors: the results of this study demonstrate that in children with ADHD administering OROS methylphenidate with or without food produces similar PK and PD profiles Comments from the review authors: despite lack of information about ADHD diagnostic criteria, the article is included ‐ because it reports data on serious adverse events (n = 0), deaths (n = 0). This means, that only data regarding serious adverse events should be extracted. Wrong NCT‐number reported Exclusion of methylphenidate non‐responders/children who have previously experienced adverse events on methylphenidate: yes Supplemental information received through personal email correspondence with the authors in August 2014. No answer received