Lijffijt 2006.
Study characteristics | ||
Methods | 3‐week, randomised, double‐blind, cross‐over, within‐participant trial conducted to test MPH/placebo to assess correlations between measures of attention and inhibition with dopamine and norepinephrine blood levels:
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Participants | Number of participants screened: not stated Number of participants included: 15 (13 boys, 2 girls) Number of participants followed up: 15 Number of withdrawals: 0 Diagnosis of ADHD: DSM‐IV (combined (11), hyperactive‐impulsive (2), inattentive (2)) Age: mean 10.74 years (range 7‐13) IQ: mean 97.60 MPH‐naive: 0% Ethnicity: not stated Country: the Netherlands Setting: outpatient clinic Comorbidity: anxiety (n = 6), ODD (n = 5) Comedication: not stated Other sociodemographics: none Inclusion criteria
Exclusion criteria
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Interventions | Participants were randomly assigned to different possible drug condition orders of 0.5 mg/kg or 1.0 mg/kg MPH and placebo Mean MPH dosage: 22.67 mg Administration schedule: not stated Duration of each medication condition: 1 day Washout before trial initiation: 24 h before testing Medication‐free period between interventions: no Titration period: none/duration Treatment compliance: not stated |
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Outcomes |
ADHD symptoms
General behaviour
Non‐serious AEs
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Notes | Sample calculation: no Ethics approval: yes; "The study was approved by the national medical ethical committee (CCMO)" Key conclusion of trial authors
Exclusion of MPH non‐responders/children who have previously experienced AEs while taking MPH before randomisation: yes, see inclusion criteria Any withdrawals due to AEs: yes, "four participants were too fatigued after placebo or the 1.0 mg/kg dose to continue with the change task after they first completed the stop task" Funding source: not declared Email correspondence with trial authors: March 2014: we sent an email to the trial author 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 | Randomised |
Allocation concealment (selection bias) | Unclear risk | No information |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Double‐blind |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Double‐blind |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No dropouts. "All participants were familiar with the intake of MPH for at least 1 year" Selection bias (e.g. titration after randomisation → exclusion of methylphenidate non‐responders or placebo responders): no |
Selective reporting (reporting bias) | Unclear risk | No protocol available |