Steele 2006.

Methods	An open‐label, 8‐week, multicentre, randomised, parallel trial with 2 arms: Osmotic release oral system (OROS) methylphenidate Usual care with immediate release (IR) methylphenidate
Participants	Number of participants screened: 187 Number of participants included: 147 Number randomised to OROS‐methylphenidate: 73 and IR‐methylphenidate: 74 Number of participants followed up: OROS‐methylphenidate: 61; IR‐methylphenidate: 62 Number of withdrawals: OROS‐methylphenidate: 12; IR‐methylphenidate: 12 Diagnosis of ADHD: DSM‐IV (subtype: combined (79.3%), hyperactive‐impulsive (2.1%), inattentive (18.6%) Age: mean: not stated (range: 6‐12) IQ: above 70 Sex: 121 males, 24 females Methylphenidate‐naïve: not stated Ethnicity: white: 86.9%, African American: 3.4%, Asian: 0.7%, others: 9.0% Country: Canada Comorbidity: oppositional defiant disorder (40.7%), conduct disorder (0.7%), anxiety (4.1%) Comedication: not stated Sociodemographics: not stated Inclusion criteria: Physically healthy Aged 6‐12 years inclusive ADHD diagnosis according to DSM‐IV Medication naïve or currently on ADHD medication therapy A baseline Clinical Global Impression‐Severity (CGI‐S) score of 4 or greater (at least 'moderate' severity) Had to demonstrate significant after‐school/evening behavioural difficulties as assessed by the clinician via parent/child interviews To approximate clinical practice settings, psychotropic medications to treat non‐ADHD disorders and psychological interventions were permitted as long as the treatment/intervention had been stable for a minimum of 4 weeks prior to entry and did not change nor newly commence during the trial Exclusion criteria: Known methylphenidate non‐responders, hypersensitivity, or adversely affected by methylphenidate Concomitant use of contraindicated medication likely to interfere with the safe administration of study medication Marked anxiety, tension, aggression/agitation Glaucoma Ongoing seizure disorder Psychotic disorder Diagnosis or family history of Tourette disorder Bipolar disorder Suspected mental retardation or significant learning disorder Medication/alcohol abuse/dependence by either the child or parent History of, or current eating disorder Severe gastrointestinal narrowing Inability to swallow study medications And any serious/unstable medical illness
Interventions	Methylphenidate type: osmotic release oral system and immediate release methylphenidate (patients were randomly assigned) Mean daily dose of OROS‐methylphenidate: 37.8 (SD 11.9) mg (1.17 (SD 0.52) mg/kg; range 18‐54 mg) Mean daily dose of IR‐methylphenidate: 33.3 (SD 13.2) mg (1.03 (SD 0.46) mg/kg; range 10‐70 mg) Administration schedule: OROS‐methylphenidate once daily in the morning and IR‐methylphenidate 2‐3 times daily Duration of intervention: 8 weeks Titration period: 4 weeks initiated after randomisation Washout: at study entry, patients on stimulant or non‐stimulant medication to treat ADHD underwent a minimum 3‐day washout Treatment compliance: the percentage of participants who missed any dose during the trial: IR‐methylphenidate (84%) and OROS‐methylphenidate (56%)
Outcomes	Non‐serious adverse events: Adverse events, physical examination, vital signs, and body weight, height
Notes	Sample calculation: yes (130 participants) Ethics approval: yes Funding/vested interest: this research was supported by Janssen‐Ortho Inc., Canada Authors' affiliations: no affiliations to pharmaceutical companies stated Key conclusions of the study authors: once‐daily OROS‐methylphenidate is significantly more effective than usual care with IR‐methylphenidate based on multiple outcome measures including remission rate Exclusion of methylphenidate non‐responders: yes, known non‐responders excluded (see exclusion criteria 1) Supplemental information requested through email correspondence with the authors in September 2013. No reply