Pelham 1999.
Study characteristics | ||
Methods | 6‐week, within‐participant, double‐blind, placebo‐controlled, cross‐over design with 5 arms:
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Participants | Number of participants screened: 26 Number of participants included: 25 (21 boys, 4 girls) Number of participants followed up: 23 Number of withdrawals: 2 Diagnosis of ADHD: DSM‐IV (subtype not stated) Age: mean 9.6 years (range 5.8‐12.7) IQ: average intelligence MPH‐naive: not stated Ethnicity: white (88%) Country: USA Setting: outpatient clinic Comorbidity: ODD (n = 13), CD (n = 8) Comedication: not stated Other sociodemographics: "Median family income was US $40 000, with incomes ranging widely (from US $10 000 per year to US $100 000 per year)" Inclusion criteria
Exclusion criteria
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Interventions | Participants were randomly assigned to receive 5 different interventions changing on a daily basis. The 5 interventions were 10 mg and 17.5 mg of IR‐MPH (Ritalin), 7.5 and 12.5 mg of MAS (Adderall) and placebo Administration schedule: 2 time points Duration of each medication condition: 5‐day period Washout before trial initiation: not stated Medication‐free period between interventions: no Titration period: none initiated before/after randomisation Treatment compliance: not stated |
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Outcomes |
ADHD symptoms
Non‐serious AEs
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Notes | Sample calculation: not stated Ethics approval: not stated Key conclusions 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: yes; 1 (exacerbation of tic disorder) Funding source: grants from the Shire Richwood Pharmaceutical Company and NIMH (Grants MH53554, MH45576 and MH50467) Email correspondence with trial authors: April 2014. We requested additional information from trial authors but have not received a reply |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "Randomized" |
Allocation concealment (selection bias) | Unclear risk | No information |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | "The clinical team was not blind to medication condition when making their recommendations. Therefore, as a reliability check of the clinical team’s recommendations, one of the authors (J.W.) who was not involved in the clinical team meetings made independent recommendations based on the same data given to the clinical team. This rater was blind to drug condition except placebo" |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | "The clinical team was not blind to medication condition when making their recommendations. Therefore, as a reliability check of the clinical team’s recommendations, one of the authors (J.W.) who was not involved in the clinical team meetings made independent recommendations based on the same data given to the clinical team. This rater was blind to drug condition except placebo" |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | No information Selection bias (e.g. titration after randomisation → exclusion): Unclear, not stated |
Selective reporting (reporting bias) | Unclear risk | No protocol identified |