Moshe 2012.
Study characteristics | ||
Methods | 2‐week, randomised, double‐blind, cross‐over trial with 2 interventions:
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Participants | Number of participants screened: 78 Number of participants included: 57 (all boys) Number of participants followed up: 57 Number of withdrawals: 0 Diagnosis of ADHD: DSM‐IV (combined and hyperactive‐impulsive (53%), inattentive (47%)) Age: mean 9.5 years (range 7‐12) IQ: normal MPH‐naive: 100% Ethnicity: not stated Country: Israel Setting: outpatient clinic Comorbidity: no Comedication: no Other sociodemographics: representing all socioeconomic strata Inclusion criteria
Exclusion criteria
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Interventions | Participants were randomly assigned to 1 of 2 possible drug condition orders of 0.3 mg/kg IR‐MPH and placebo MPH dose range: 6 mg‐12 mg Administration schedule: once daily Duration of each medication condition: 1 week Washout before trial initiation: no (drug‐naive) Titration period: no Treatment compliance: not stated |
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Outcomes |
ADHD symptoms
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Notes | Sample calculation: yes Ethics approval: yes Comments from 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: none Email correspondence with trial authors: April‐October 2013. We received supplemental data from trial authors |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomly assigned with a table of random numbers |
Allocation concealment (selection bias) | Low risk | Placebo (prepared as look‐alike capsules by the hospital pharmacy) |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Double‐blind |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Double‐blind |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No withdrawals Selection bias (e.g. titration after randomisation → exclusion): no |
Selective reporting (reporting bias) | Low risk | No indication of selective reporting. According to trial authors, all planned outcomes were assessed and analysed |