Rapport 1985.
Study characteristics | ||
Methods | Triple‐blind, randomised, cross‐over trial with 4 interventions:
Phases
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Participants | Number of participants screened: 22 Number of participants included: 14 (12 boys, 2 girls) Number of participants followed up: 11 Number of withdrawals: 1 Number of participants excluded during the trial: 2 Diagnosis of ADHD: DSM‐III (subtype not stated) Age: 8.3/7.75 years (range 6‐10) IQ: > 100 MPH‐naive: not stated Ethnicity: white (86%), not stated (14%) Country: USA Setting: outpatient clinic Comorbidity: not stated Comedication: no Other sociodemographics: low to middle socioeconomic status Inclusion criteria
Exclusion criteria
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Interventions | Participants were randomly assigned to 1 of 24 possible drug condition orders of fixed doses of MPH (5 mg, 10 mg, 15 mg) and placebo. As a result of the small sample size, not all drug orders were used. Post hoc comparison showed that doses were distributed approximately equally across different positions in the sequence Administration schedule: once daily, in the morning Duration of each medication condition: 7 days Washout before trial initiation: none, but all weekly dosage changes occurred on Saturdays to control for potential rebound effects Titration period: none Treatment compliance: both used and unused envelopes with capsules were returned to control for medication compliance. No results regarding compliance were reported |
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Outcomes |
ADHD symptoms
No useable data |
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Notes | Sample calculation: not stated Ethics approval: not stated Key conclusion of trial authors
Comment from review 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: July 2013. Trial authors informed us that original records were shredded after 20 years, and that they could not provide the requested data (Ramstad 2013c [pers comm]) |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Order of drug administration was determined by randomly assigning each child to 1 of 24 possible drug disorders |
Allocation concealment (selection bias) | Low risk | MPH was packaged by the pharmacist in coloured gelatin capsules to avoid detection of dose and taste. Capsules were placed in individually dated envelopes to ensure accurate dose administration |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Triple‐blind design (children, teachers and observers were blinded) |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Teachers and observers were blind to when medication was administered and what specific doses were given |
Incomplete outcome data (attrition bias) All outcomes | High risk | Selection bias (e.g. titration after randomisation → exclusion of MPH non‐responders or placebo responders): yes, data from 2 of 12 children in the present investigation were not included in the statistical analyses because they were classified as non‐responders according to results of the Paired Associates Learning test |
Selective reporting (reporting bias) | Unclear risk | Not possible to receive a copy of the protocol |