Sunohara 1999.
Study characteristics | ||
Methods | Cross‐over trial with 3 arms:
Phases: 3 |
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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
Exclusion criteria
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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 |
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Outcomes |
Non‐serious AEs
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Notes | Sample calculation: not stated Ethics approval: no information Key conclusion of trial authors
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 |
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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 |