DuPaul 1996.
Study characteristics | ||
Methods | 4‐week, double‐blind, placebo‐controlled, cross‐over trial in which participants were randomly assigned to 3 doses of MPH:
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Participants | Number of participants screened: not stated Number of participants included: 24 (19 boys, 5 girls) Number of participants followed up: 24 Number of withdrawals: 0 Diagnosis of ADHD: DSM‐III‐R (subtype not stated) Age: mean 11.09 years (range 9‐15) IQ: > 70 MPH‐naive: not stated Ethnicity: white (100%) Country: USA Setting: outpatient clinic Comorbidity: ODD (21%), CD (% not reported) Comedication: not stated Other sociodemographics: children were primarily from lower‐middle class and middle class families Inclusion criteria
Exclusion criteria
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Interventions | Participants were randomly assigned to 1 of 6 possible drug condition orders of low‐ (0.16 mg/kg; SD 0.08), moderate‐ (0.29 mg/kg; SD 0.11 kg) and high‐dose (0.42 mg/kg; SD 0.14) MPH and placebo Administration schedule: twice/d, morning, noon Duration of each medication condition: 1 week Washout before trial initiation: not stated Titration period: none Treatment compliance: no participant was removed from the investigation for non‐compliance (e.g. > 1 day of failure to administer medication as scheduled) |
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Outcomes |
ADHD symptoms
Non‐serious AEs
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Notes | Sample calculation: no information Ethics approval: Human Subjects Research Board at the University of Massachusetts Medical Center 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: not stated Email correspondence with trial authors: January 2013‐August 2013. Emailed first trial author regarding additional information. Not able to get all data requested, as trial author no longer has these data |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Children were randomly assigned to 1 of 6 possible orders of MPH dosage |
Allocation concealment (selection bias) | Low risk | Medication was prepared by the hospital pharmacy in increments of 5 mg and packaged within opaque gelatin capsules |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Participants, their parents and teachers and the research assistant in charge of collecting data were blinded to the order of medication |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Participants, their parents and teachers and the research assistant in charge of collecting data were blinded to the order of medication |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No Selection bias (e.g. titration after randomisation → exclusion): no |
Selective reporting (reporting bias) | Low risk | No indication of reporting bias. Analyses on all dependent measures in the trial are reported in the article |