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. 2023 Mar 27;2023(3):CD009885. doi: 10.1002/14651858.CD009885.pub3

Sunohara 1999.

Study characteristics
Methods Cross‐over trial with 3 arms:
  • LD‐MPH

  • HD‐MPH

  • placebo


Phases: 3
Participants Number of participants screened: not stated
Number of participants included: 20 (16 boys, 4 girls)
Number of participants followed up: 20
Number of withdrawals: 0
Diagnosis of ADHD: DSM‐III‐R (subtype not stated)
Age: mean 10.5 years (range 10‐12)
IQ: < 80
MPH‐naive: none
Ethnicity: not stated
Country: Canada
Setting: outpatient clinic
Comorbidity: ODD (n = 4), learning disability (n = 8)
Comedication: not stated
Other sociodemographics: none
Inclusion criteria
  • Children 10‐12 years of age meeting DSM‐II‐R criteria for ADHD recruited from Child Development Centre at Hospital for Sick Children, Canada


Exclusion criteria
  • CD, externalising disorder, anxiety

  • IQ < 80

Interventions Participants were randomly assigned to LD‐MPH (mean 0.28 mg/kg) and HD‐MPH (mean 0.56 mg/kg) and placebo in the morning and afternoon
Duration of each medication condition: 2 days
Washout before trial initiation: no
Titration period: no
Treatment compliance: not stated
Outcomes Non‐serious AEs
  • Reported as adverse effects. There were 0 adverse effects at the higher dose for all children

Notes Sample calculation: not stated
Ethics approval: no information
Key conclusion of trial authors
  • No adverse effects of the higher dose were reported for any children


Exclusion of MPH non‐responders/children who have previously experienced AEs while taking MPH before randomisation: unclear
Any withdrawals due to AEs: no
Funding source: RESTRACOM graduate studentship for The Hospital for Sick Children Research Institute and Novartis Pharmaceuticals
Email correspondence with trial authors: April 2014. Wrote to trial authors to ask for additional data but have not received a reply
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Not stated
Allocation concealment (selection bias) Unclear risk Not stated
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Not stated
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk Not stated
Incomplete outcome data (attrition bias)
All outcomes Low risk All participants were followed up
Selection bias (e.g. titration after randomisation → exclusion of MPH non‐responders or placebo responders): no
Selective reporting (reporting bias) Unclear risk No protocol identified