Pliszka 2007.
Study characteristics | ||
Methods | 5‐week double‐blind, cross‐over, placebo‐controlled trial, conducted to examine electrophysiological effects of MPH on inhibitory control in children with ADHD
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Participants | Number of participants screened: 12 Number of participants included: 12 (8 boys, 4 girls) Number of participants followed up: 12 Number of withdrawals: 0 Diagnosis of ADHD: DSM‐IV (combined (100%)) Age: mean 12.3 years (range 9‐15) IQ: not stated MPH‐naive: 10 Ethnicity: white (67%), African American (8%), Hispanic (25%) Country: USA Setting: not stated Comorbidity: ODD (45%) 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 5 mg, 10 mg, 15 mg, 20 mg MPH and placebo Mean MPH dosage: not stated Administration schedule: 3 time points Duration of each medication condition: 7 days Washout before trial initiation: not stated Medication‐free period between interventions: 0 Titration period: none initiated before/after randomisation |
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Outcomes |
General behaviour
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Notes | Sample calculation: no Ethics approval: yes; trial approved by the Institutional Review Board of the University Comments from trial authors
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: no Funding source: NIMH Grant R01 MH63986 Email correspondence with trial authors: May 2014. Trial authors could not give us the necessary data (e.g. separate data for each intervention period); therefore we could not use CGI data |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Comment: insufficient information regarding generation of random sequence allocation to permit a judgement of low or high risk of bias. |
Allocation concealment (selection bias) | Unclear risk | From email: "one investigator was assigned on the basis of chance; the other remained blinded" |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Double‐blind. One investigator assigned on the basis of chance; the other remained blinded |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | One investigator assigned on the basis of chance; the other remained blinded |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No dropouts Selection bias (e.g. titration after randomisation → exclusion): no |
Selective reporting (reporting bias) | Unclear risk | No protocol identified |