Swanson 2002a.

Study characteristics
Methods	Randomised, double‐blind, cross‐over design: IR‐MPH 3 times/d or MPH experimental administration placebo
Participants	Number of participants screened: not stated Number of participants included: 32 (28 boys, 4 girls) Number of participants followed up: 30 Number of withdrawals: 2, due to personal commitments Diagnosis of ADHD: DSM‐IV (combined (93.8%), hyperactive‐impulsive (6.2%), inattentive (0%)) Age: mean 9.9 years (range 7‐13) IQ: not stated MPH‐naive: 0%, all children in the trial were undergoing treatment with MPH when they were enrolled Ethnicity: not stated Country: USA Setting: outpatient clinic (laboratory classroom) Comorbidity: 0% Comedication: not stated Other sociodemographics: none Inclusion criteria ADHD Normal BP Not physically ill Able to understand that they could withdraw from the trial at any time Exclusion criteria ODD CD Mood disorders Anxiety disorders
Interventions	Participants were randomly assigned to 1 of 3 possible drug condition orders of 5 mg, 10 mg or 15 mg, 3 times/d or 18 mg/d, 36 mg/d or 54 mg/d administered in bolus at 7:30 am and once every 30 min for 8 h of MPH and placebo Mean MPH dosage: not stated Administration schedule: 3 time points Duration of each medication condition: 1 day Washout before trial initiation: not stated Medication‐free period between interventions: none Titration period: none Treatment compliance: not stated
Outcomes	ADHD symptoms SKAMP General behaviour ActiGraph activity measurements Non‐serious AEs Proof of Concept Study (n = 32) Teachers: appetite loss (3 times/d, n = 6; ascending, n = 7) Parent reports of somatic complaints (primarily headache or stomachache): 3 times/d MPH (n = 9), ascending (n = 5) Sleep onset was delayed slightly in the medication conditions (ascending, 0.65 h; 3 times/d, 0.55 h)
Notes	Sample calculation: not stated Ethics approval: yes Comments from trial authors (limitations) Lack of normal control participants Use of subjective rating measures Use of different ActiGraph modes of operation Lack of a systematic evaluation of whether baseline levels of behaviour were predictive of medication effects Key conclusions of trial authors Combination of an initial bolus of MPH and an ascending pattern of small doses significantly decreased hyperactivity and reduced inappropriate behaviour Studies showed acute tolerance to clinical doses of MPH and application of this: creation of an ascending drug delivery pattern (OROS) of rapid onset and with long duration of effect Exclusion of MPH non‐responders/children who have previously experienced AEs while taking MPH before randomisation: yes, all children in the trial were undergoing treatment with MPH when they were enrolled Any withdrawals due to AEs: no Funding source: funding: ALZA Corporation Email correspondence with trial authors: trial authors were contacted twice by email and were asked for much supplemental information regarding data, but we have received no data; therefore, most of the data from this trial cannot be used in this review.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	"Randomized, 3‐way, crossover trial in which a double‐blind, double‐dummy procedure was used"
Allocation concealment (selection bias)	Unclear risk	Not enough information
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Not enough information
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Not enough information
Incomplete outcome data (attrition bias) All outcomes	Low risk	Only 2 withdrawals, due to personal commitments Selection bias (e.g. titration after randomisation → exclusion of MPH non‐responders or placebo responders): no
Selective reporting (reporting bias)	Low risk	"Two additional items developed (from SKAMP) for the NIMH Collaborative Multisite Multimodal Treatment Study of Children With ADHD (MTA) (Greenhill et al., 2001) were included in the classroom ratings but were not included in the analyses of this study"