Tannock 1993.
Study characteristics | ||
Methods | Cross‐over trial with 3 interventions:
Phases
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Participants | Number of participants screened: not stated Number of participants included: 22 (and 16 healthy controls) Number of participants followed up: 22 (21 boys, 1 girl) Number of withdrawals: 0 Diagnosis of ADHD: DSM‐III (subtype not stated) Age: mean 9.4 years (range not stated) IQ: mean 105.5 (SD 11.3) MPH‐naive: not clear: "Thus all these children would have received a trial with psychostimulants independently of this study"; "8 children had been receiving stimulant medication prior to this study") Ethnicity: not stated Country: Canada Setting: outpatient clinic Comorbidity: 55%; oppositional disorder (n = 5), CD (n = 3), emotional disorder as well as oppositional or CD (n = 4), major depression (n = 2), avoidant disorder (n = 1), separation anxiety disorder (n = 1) and learning disorder (n = 6) Comedication: not clear Other sociodemographics: none Inclusion criteria
Exclusion criteria
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Interventions | Participants were randomly assigned to 1 of 6 possible drug condition orders of (dose not stated) MPH and placebo Mean MPH dosage: not stated Administration schedule: 6 separate medication administrations: 2 placebo, 2 LD (0.3 mg/kg) and 2 HD (1.0 mg/kg). First 3 test sessions were ordered randomly, then were ordered repeatedly for last 3 sessions: daily for 6 days Duration of each medication condition: 3 h Washout before trial initiation: 48 h Medication‐free period between interventions: not clear Titration period: none Treatment compliance: "Medication was administered by project staff" |
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Outcomes |
Non‐serious AEs
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Notes | Sample calculation: no Ethics approval: not stated Key conclusions of trial authors
Exclusion of MPH non‐responders/children who have previously experienced AEs while taking MPH before randomisation: unclear Withdrawals due to AEs: no Funding source: Canadian Psychiatric Research Foundation and the Medical Research Council of Canada. Email correspondence with trial authors: April 2014. Emailed trial authors twice for supplemental information/data but have received no response |
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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) | Low risk | Double‐blind, placebo‐controlled, within‐participant design was used ...randomly assigned, counterbalanced sequence. Medications were prepared individually for each child and were packaged in coloured gelatin capsules to avoid detection of dose and taste |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Double‐blind, placebo‐controlled, within‐participant design was used ...randomly assigned, counterbalanced sequence. Medications were prepared individually for each child and were packaged in coloured gelatin capsules to avoid detection of dose and taste |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Unclear |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No withdrawals were noted Selection bias (e.g. titration before randomisation → exclusion): no |
Selective reporting (reporting bias) | Low risk | No indication of selective reporting, all outcomes reported |