Taylor 1993.
Study characteristics | ||
Methods | 4‐week, double‐blind, cross‐over trial with 3 interventions:
Each medication dose/placebo was given for 1 week |
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Participants | Number of participants screened: 57 Number of participants included: 57 (27 boys, 5 girls) Number of participants followed up: all 57 completed the trial but only 32 were included in the final analysis Number of withdrawals: 0, but 25 were not reported (due to non‐response and not enough data) Diagnosis of ADHD: DSM‐III‐R Age: mean 10.26 years (range 7.0‐12.9) IQ: mean 107 (SD 16.2; range 78‐139) MPH‐naive: 12 (37.5%) Ethnicity: not stated Country: Canada Setting: outpatient clinic Comorbidity: not stated Comedication: not stated Other sociodemographics: none Inclusion criteria
Exclusion criteria
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Interventions | Participants were randomly assigned to possible drug condition orders of, respectively, mean 6.72 mg (5 mg‐10 mg) and mean 11.88 mg (10 mg‐15 mg) MPH and placebo Administration schedule: morning and noon Duration of each medication condition: 1 week Washout before trial initiation: none Titration period: none Treatment compliance: no information |
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Outcomes |
Non‐serious AEs
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Notes | Sample calculation: no information Ethics approval: no information Key conclusion of trial authors
Inclusion of MPH responders only/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: not declared Email correspondence with trial authors: January 2014. No supplemental information was received. We therefore have no more information on numbers of participants with non‐serious AEs. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Randomised. All medication and placebo testing was conducted under double‐blind conditions with randomly assigned testing order |
Allocation concealment (selection bias) | Unclear risk | No information |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Active medication and placebo substances were placed in identical red and white capsules in powder form. Matched on both taste and appearance |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | All medication and placebo testing was conducted under double‐blind conditions with randomly assigned testing order, but how blinding was done was not described |
Incomplete outcome data (attrition bias) All outcomes | High risk | Selection bias (e.g. titration after randomisation → exclusion): this series of 32 children with ADHD does not include an additional group of 12 children with ADHD, who after drug trials were deemed "non‐responders" as well as 13 participants on whom adequate Event‐Related Potentials data were not obtained |
Selective reporting (reporting bias) | High risk | Did not report AE data |