Tannock 1989.
Study characteristics | ||
Methods | Within‐participant, cross‐over trial with 3 interventions:
2 different drug conditions each day |
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Participants | Number of participants screened: 16 Number of participants included: 12 Number of participants followed up: 12 (10 boys, 2 girls) Number of withdrawals: none Diagnosis of ADHD: DSM‐III ADD‐H (equivalent to 'combined' in later classifications) Age: mean 8.4 years (range 6‐11) IQ: mean 105 MPH‐naive: 5 received MPH previously. 3 were taking MPH at the time of referral and had a 48‐h pre‐trial washout Ethnicity: not stated Country: Canada Setting: outpatient clinic Comorbidity: ODD (n = 4), learning difficulties (n = 8; according to school record and defined as < 25th percentile on ≥ 1 subtests within the Wide Range Achievement Test (WRAT‐R)) Comedication: not stated Other sociodemographics: none Inclusion criteria
Exclusion criteria
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Interventions | Participants were randomly assigned to 1 of 3 possible drug condition orders of 0.3 mg/kg or 1.0 mg/kg MPH and placebo Mean MPH dosage: not stated. Administration schedule: interval of 4 h separated morning and afternoon doses Duration of each medication condition: not stated Washout before trial initiation: 4 h Titration period: none Treatment compliance: not stated |
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Outcomes |
Non‐serious AEs
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Notes | Sample calculation: not stated Ethics approval: not stated Key conclusions of trial authors
Comment from review 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: Jointly funded by Ontario Mental Health Foundation (Grant Number 963‐86/88) and Health and Welfare Canada (Grant Number 6606‐3166‐42) Email correspondence with trial authors: sent email to trial authors to ask for additional information but have not received a reply. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "The order of medication condition was randomized with the restrictions that each child receive two different medication conditions each day (e.g. high, low) occur with equal frequency in the morning and afternoon" "The order of these six combinations was randomized for each child" |
Allocation concealment (selection bias) | Unclear risk | Not stated |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | "The methylphenidate and placebo were packaged in coloured gelatin capsules by the hospital pharmacist to avoid detection of dose and taste, packaged in individual envelopes and dispensed by project staff 1 hour before testing" |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not stated |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No dropouts Selection bias (e.g. titration after randomisation → exclusion): no |
Selective reporting (reporting bias) | Unclear risk | No protocol identified |