Pliszka 2000.

Study characteristics
Methods	3‐week, randomised, double‐blind, placebo‐controlled, parallel trial with 3 arms: MAS (Adderall) MPH placebo
Participants	Number of participants screened: 73 Number of participants included: 58 Number randomly assigned: MPH 20, placebo 18 Number followed up: MPH 19, placebo 16 Number of withdrawals: MPH 1, placebo 2 Diagnosis of ADHD: DSM‐IV. DISC diagnosis of ADHD (subtype not stated) Age: mean 9 years (range not reported) IQ: > 75 MPH‐naive: MPH 5 (25%), placebo 1 (6%) Ethnicity: not stated Country: USA Setting: outpatient clinic Comorbidity: ODD (MPH 14%, placebo 10%), CD (MPH 1%, placebo 2%), anxiety disorder (MPH 20%, placebo 5%) Comedication: not stated Other sociodemographics: no significant difference in baseline demographics were noted between the 2 groups Inclusion criteria Children in grades 1‐5 ADHD according to DISC IQ > 75 ≥ 1.5 SD above the mean for his/her age and sex on the IOWA CTRS, Inattention/Overactivity factor Exclusion criteria Other medical illness Meeting DISC criteria for major depression episode, manic episode or tic disorder History of psychosis or signs of psychosis or significantly depressed mood on the mental status examination Current treatment consists of non‐stimulant psychotropic medication
Interventions	Participants were randomly assigned to IR‐MPH or placebo Mean MPH dosage: total dose 25.2 mg/d Administration schedule: 17 (85%) received ≥ 2 doses Time points: 1‐3 times/d: morning, after school and additional noon if needed Duration of intervention: 3 weeks Titration period: none Treatment compliance: not stated. Dosage was adjusted at the end of weeks 1 and 2 via an algorithm based on teacher and parent ratings
Outcomes	ADHD symptoms IOWA CTRS: rated twice daily (morning and afternoon) Mondays through Thursdays General behaviour CGI: parent‐rated Non‐serious AEs Multi‐Modality Treatment of ADHD (MTA) side effects scale: parent‐rated weekly (Thursday evenings)
Notes	Sample calculation: no Ethics approval: no Comment from trial authors Mean mg/kg dose for MPH non‐responders was 0.43, which is less than the 0.3 mg/kg to 0.8 mg/kg dose known to be required for adequate response in some children with ADHD Key conclusion of trial authors Both medications were superior to placebo for reducing inattentive and oppositional symptoms in the classroom and on the CGI Exclusion of MPH non‐responders/children who have previously experienced AEs while taking MPH before randomisation: no Any withdrawals due to AEs: yes, 3 Funding source: Shire Richwood Incorporated Email correspondence with trial authors: January 2014. Supplemental information received from trial authors
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Randomly assigned: "We used a random number generator to determine which of the 3 groups the child was assigned to"
Allocation concealment (selection bias)	Unclear risk	No information
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Parents, children, teachers and treating physicians were blind to medication status. Medication was crushed, mixed with a blue food powder and placed in opaque capsules
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Placebo participants were randomly assigned to follow MPH or MAS treatment algorithm. The blinded psychiatrist could not determine the child’s medication status simply by knowing which algorithm was being followed. Principal Investigator knew the medication status of participants
Incomplete outcome data (attrition bias) All outcomes	High risk	Morning and afternoon IOWA scores were averaged at the end of the week Selection bias (e.g. titration after randomisation → exclusion): no
Selective reporting (reporting bias)	Low risk	All planned outcomes were reported