McInnes 2007.
Study characteristics | ||
Methods | Cross‐over trial with 2 interventions:
Phases: 4 |
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Participants | Number of participants screened: 17 Number of participants included: 16 (12 boys, 4 girls) Number of participants followed up: 16 Number of withdrawals: 0 Diagnosis of ADHD: DSM‐IV‐TR (combined (63%), hyperactive‐impulsive (6%), inattentive (31%)) Age: mean 9.2 years (range 7‐12) IQ: mean 107.7 (range not reported) MPH‐naive: ~ 80% Ethnicity: not stated Country: Canada Setting: outpatient clinic Comorbidity: ODD (19%), CD (25%), generalised anxiety disorder (31%) Comedication: not stated Other sociodemographics: none Inclusion criteria
Exclusion criteria
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Interventions | Participants were randomly assigned to 1 of 12 possible drug condition orders of low, medium and high MPH and placebo Mean MPH dosage: LD (mean 0.21 mg/kg to 0.33 mg/kg, SD 0.07 to 0.02); MD (mean 0.31 mg/kg to 0.43 mg/kg, SD 0.09 to 0.03); and HD (mean 0.42 mg/kg to 0.65 mg/kg, SD 0.13 to 0.15) MPH Administration schedule: 1/d at 9:00 am Duration of each medication condition: 1 day Washout before trial initiation: 48 h before trial Titration period: none Treatment compliance: not stated |
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Outcomes |
ADHD symptoms
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Notes | Sample calculation: no Ethics approval: yes Comments from trial authors
Key conclusions of trial authors
Exclusion of MPH non‐responders/children who have previously experienced AEs while taking MPH before randomisation: no Any withdrawals due to AEs: no Funding source: The Psychiatric Endowment Fund |
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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 | "Multiple blind procedures", capsules identically packaged by pharmacists |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | "Examiner, who was kept blind to child’s medication status" |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No LTFU Selection bias (e.g. titration after randomisation → exclusion): no |
Selective reporting (reporting bias) | High risk | Symptom data not reported |