Gadow 1990.
Study characteristics | ||
Methods | 6‐week double‐blind, cross‐over trial in which participants received the following in random order:
Furthermore, a single case report from the trial is described |
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Participants | Number of participants screened: not stated Number of participants included: 11 (11 boys, 0 girls) Number of participants followed up: between 9 and 10, depending on ratings Number of withdrawals: 1‐2 Diagnosis of ADHD: DSM‐III (type not stated) Age: mean not reported (range 5.9‐11.9 years) Case report: 10 years of age IQ: > 75 Stimulant‐naive: 6 Ethnicity: not stated Country: USA Setting: outpatient clinic Comorbidity: disruptive behaviour disorder Comedication: not reported Other sociodemographics: children represented a full range of socioeconomic backgrounds Inclusion criteria
Exclusion criteria
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Interventions | Participants were randomly assigned to 1 of 6 possible drug condition orders of LD‐MPH (0.3 mg/kg) and MD‐MPH (0.6 mg/kg) (upper limit 25 mg) and placebo Mean MPH dosage: not stated Administration schedule: twice/d, morning, noon, 3.5 h apart, 7 d/week Duration of each medication condition: 2 weeks Washout before trial initiation: yes Titration period: when MD was not preceded by LD condition, the child was gradually built up to MD. Data from these titration days were excluded from the analyses Treatment compliance: pill count, no further information |
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Outcomes |
ADHD symptoms
Non‐serious AEs
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Notes | Sample calculation: no information Ethics approval: no information Comment from trial authors
Key conclusion of 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: Ciba Pharmaceutical Company supplied MPH placebo Email correspondence with trial authors: July 2013. Emailed first trial author twice to get additional information (funding, ethics approval, etc.) and data from the trial. Trial authors not able to provide us with additional data |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Dose schedules were assigned on a random basis |
Allocation concealment (selection bias) | Low risk | Medication and placebo pills were identical and were dispensed to parents and school nurses in dated, sealed envelopes |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Parents, teachers, observers, treating physicians and children were blinded to dose and order |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Parents, teachers, observers, treating physicians and children were blinded to dose and order |
Incomplete outcome data (attrition bias) All outcomes | Low risk | For classroom analyses, data on 10 boys were analysed, and for lunch room analyses, data on 9 boys were analysed Selection bias (e.g. titration before randomisation → exclusion): no |
Selective reporting (reporting bias) | Unclear risk | No protocol identified. Email sent to first trial author. No answer; therefore not able to get information |