Pelham 2001a.

Study characteristics
Methods	Cross‐over trial with 3 interventions: ER‐MPH (Concerta) IR‐MPH placebo Phases: 3
Participants	Number of participants screened: 70 Number of participants included: 68. (89% boys, 11% girls) Number of participants followed up: 68 (66 for ADHD symptoms) Number of withdrawals: 2 Diagnosis of ADHD: DSM‐IV (subtype not stated) Age: mean 9.1 years (range 6‐12) IQ: mean 104.8 MPH‐naive: 0% Ethnicity: white (94%), other (6%) Country: USA Setting: outpatient clinic (Summer Treatment Program) Comorbidity: ODD (43%), CD (37%) Comedication: no Other sociodemographics: none Inclusion criteria Children 6‐12 years of age with ADHD were recruited via several sources, including advertisement; physician, agency and school referral; and parent referral All participants were required to be medicated with MPH and to receive a stable dose for ≥ 4 weeks before the start of the trial Exclusion criteria Medical condition that would contraindicate the use of stimulants Physical condition or severe learning difficulty that would interfere with participation in trial, including IQ < 80 Receiving additional medication for ADHD Any medication with CNS effects, anticonvulsants or investigational medications Reached menarche BP ≥ 95th age and height percentile
Interventions	Participants were randomly assigned to different possible drug condition orders of IR‐MPH 3 times/d, Concerta MPH once/d, and placebo Mean MPH dosage: 0.75 mg/kg (SD 0.34) (3 dosing levels were used: 5 mg IR‐MPH 3 times/d or 18 mg ER‐MPH (Concerta) daily 10 mg IR‐MPH 3 times/d or 36 mg ER‐MPH (Concerta) once/d 15 mg IR‐MPH 3 times/d or 54 mg ER‐MPH (Concerta) once/d The dose level used for each child was based on that child’s MPH dosing before the start of the trial Administration schedule: IR‐MPH 3 times/d or ER‐MPH (Concerta) once daily Duration of each medication condition: 7 days Washout before trial initiation: not described Titration period: none Treatment compliance: "virtually 100%"
Outcomes	ADHD symptoms Teachers and parents completed weekly symptom ratings using the IOWA CRS Teachers and parents rated oppositional defiant behaviour weekly using the Abbreviated CRS Teacher ratings on the SKAMP, daily Non‐serious AEs Reports of AEs were collected via spontaneous reports over the course of the trial. Additionally, each week, parents provided responses to questions on AEs, sleep quality, appetite and tics
Notes	Sample calculation: no Ethics approval: yes Comment from trial authors All participants also received a behavioural intervention Key conclusion of trial authors "This investigation clearly supports the efficacy of the Concerta long‐acting formulation of MPH for parents who wish to have medication benefits for their child throughout the day and early evening" Exclusion of MPH non‐responders/children who have previously experienced AEs while taking MPH before randomisation: yes; all participants were required to be medicated with MPH and were receiving a stable dose for ≥ 4 weeks before the start of the trial Any withdrawals due to AEs: no Funding source: ALZA Corporation, the manufacturers of Concerta Email correspondence with trial author: June 2014. Emailed trial author to ask for additional information but have not received a reply
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Not described
Allocation concealment (selection bias)	Unclear risk	Not described
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Referred to as double‐blind; capsules were identical
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Referred to as double‐blind; capsules were identical
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Data reported for 66/70 for ADHD and behaviour Selection bias (e.g. titration after randomisation → exclusion): no
Selective reporting (reporting bias)	Unclear risk	No protocol available