Shiels 2009.
Study characteristics | ||
Methods | 3‐day, double‐blind, placebo‐controlled cross‐over trial with 3 arms:
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Participants | Number of participants screened: not stated Number of participants included: 49 (80% boys, 20% girls) Number of participants followed up: not stated Number of withdrawals: 0 Diagnosis of ADHD: DSM‐IV (combined 35 (71%), hyperactive‐impulsive 3 (6%), inattentive 11 (23%)) Age: mean 10.5 years (range 9‐12) IQ: mean 104 (range not stated) MPH‐naive: not stated Ethnicity: white (76%), African American (14%), other (10%) Country: USA Setting: outpatient clinic (summer research programme) Comorbidity: ODD (43%), CD (22%) Comedication: not stated Other sociodemographics: none Inclusion criteria
Exclusion criteria
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Interventions | Participants were assigned to extended‐release MPH in "high" or "low" dose (range 18‐90 mg/d) No of participants randomised: not stated Mean MPH: LD 39 mg (Concerta), HD 73 mg (Concerta) Administration schedule: once daily Time points: in the morning, 90 min before cognitive task Duration of intervention: 7:30 am‐5:00 pm, Monday through Thursday Titration period: not stated Treatment compliance: not stated Washout before trial initiation: MPH 1 week if taking atomoxetine, 24 h if taking MPH |
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Outcomes |
General behaviour
Non‐serious AEs
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Notes | Sample calculation: not stated Ethics approval: not stated Key conclusions of trial authors
Comment from review authors
Exclusion of MPH non‐responders/children who have previously experienced AEs while taking MPH before randomisation: no Any withdrawals due to AEs: none Funding source: National Institute of Mental Health Email correspondence with trial authors: July 2014. Emailed trial authors to request additional information but have not received a response |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not described |
Allocation concealment (selection bias) | Unclear risk | Not described |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | "To maintain blinding, participants were given the same number of opaque capsules per day regardless of actual MPH dose" |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No information |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No withdrawals Selection bias (e.g. titration after randomisation → exclusion): no |
Selective reporting (reporting bias) | Unclear risk | No protocol identified |