Solanto 2009.
Study characteristics | ||
Methods | Cross‐over trial with 2 interventions:
Phases: week‐long exposure to placebo and to each of 3 different dosage regimens of IR‐MPH |
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Participants | Number of participants screened: not stated Number of participants included: 30 Number of participants followed up: 25 Number of withdrawals: 5 Diagnosis of ADHD: DSM‐IV (combined (60%), inattentive (40%)) Age: mean 8.53 (combined) and 9.20 (inattentive) IQ: not stated MPH‐naive: all but 1 were stimulant‐naive Ethnicity: not stated Country: USA Setting: hospital Comorbidity: ODD (combined 13%, predominantly inattentive 20%); learning disability (combined 40%, predominantly inattentive 20%); anxiety (combined 0%, predominantly inattentive 10%) Comedication: no Other sociodemographics: minority representation (combined 53%, predominantly inattentive 20%) Inclusion criteria
Exclusion criteria
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Interventions | Participants were randomly assigned to 1 of 24 possible drug condition orders of LD‐, MD‐ and HD‐MPH and placebo Mean MPH dosage (Combined vs predominantly Inattentive): LD 0.50 ± 0.12 vs 0.44 ± 0.13; MD 0.83 ± 0.20 vs 0.73 ±‐0.21; HD 1.54 ± 0.31 vs 1.40 ± 0.38 Administration schedule: 3 times daily: morning, midday and 3:00 pm Duration of each medication condition: 1 week Washout before trial initiation: not required Medication‐free period between interventions: no Titration period: open‐label lead‐in week, not specified whether before or after randomisation of treatment Treatment compliance: not stated |
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Outcomes |
ADHD symptoms
Non‐serious AEs
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Notes | Sample calculation: no Ethics approval: not stated Key conclusion of trial authors
Exclusion of MPH non‐responders/children who have previously experienced AEs while taking MPH before randomisation: unclear if there was an open‐label titration phase before randomisation Any withdrawals due to AEs: yes; 2 Funding source: not declared Email correspondence with trial authors: April 2014. We received supplemental information from trial authors |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not stated |
Allocation concealment (selection bias) | Low risk | Double‐blind, cross‐over with week‐long exposure to placebo and each of 3 different dosage regimens of IR‐MPH in randomly assigned order |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Double‐blind, cross‐over with week‐long exposure to placebo and each of 3 different dosage regimens of IR‐MPH in randomly assigned order. Trial medications were prepared and coded by the hospital pharmacy using identical gelatin capsules for active medication and placebo |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not stated |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Across the 4 placebo and drug conditions, data points were missing as follows: CPRS 1%, CTRS 6%, Parent SKAMP 1%, Teacher SKAMP 4%, Side Effects 0%. Missing scores were replaced by the mean of scores for that group in that condition Selection bias: titration conducted but unclear whether before or after randomisation. No participants were excluded after the 1‐week titration period |
Selective reporting (reporting bias) | Low risk | Protocol identified; all outcomes reported |