Hoeppner 1997.
Study characteristics | ||
Methods | Double‐blind, cross‐over trial with 2 interventions:
4 orders
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Participants | Number of participants screened: 95 Number of participants included: 50 Number of participants followed up: 50 (39 boys, 11 girls) Number of withdrawals: none Diagnosis of ADHD: DSM‐III‐R Age: mean 9.6 years (range 6‐18.1) IQ: not stated MPH‐naive: not stated Ethnicity: not stated Country: USA 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 different possible orders of HD‐MPH (0.3 mg/kg), LD‐MPH (0.15 mg/kg) and placebo (doses rounded up to the nearest 2.5 mg) Mean MPH dosage: not stated Administration schedule: twice/d, 8:00 am and 12:00 pm Duration of each medication condition: 1 week Washout before trial initiation: "received an appropriate wash‐out period" Medication‐free period between interventions: from lunchtime until next morning, 20 h Titration period: none Treatment compliance: not stated |
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Outcomes |
ADHD symptoms
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Notes | Sample calculation: no Ethics approval: no information Comments 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: not declared Email correspondence with trial authors: March 2014. Emailed trial authors to request additional information but have received no reply |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | No information |
Allocation concealment (selection bias) | Low risk | Pharmacists randomly assigned participants to 1 of 4 trial sequences |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Placebo consisted of an opaque capsule filled with lactose; active drug consisted of the same lactose‐filled capsule, to which MPH was added |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Placebo consisted of an opaque capsule filled with lactose; active drug consisted of the same lactose‐filled capsule, to which MPH was added |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No dropouts Selection bias (e.g. titration after randomisation → exclusion): no |
Selective reporting (reporting bias) | Low risk | No indication of reporting bias |