Findling 2011.
Methods | Multi‐center, randomized, double‐blind, placebo‐controlled, parallel‐group trial Country: United States Number of study sites: 45 Statistical methods: modified ITT (last observation carried forward) | |
Participants | Sample size: 314 children/adolescents with an ADHD diagnosis according to DSM‐IV‐TR criteria Dropouts: 52 Psychiatric comorbid conditions: NR Age range: 13 years to 17 years Mean age (SD): 14.6 (1.31) years Sex: 249 (79%) males ADHD subtype: 203 (65%) combined | |
Interventions |
Four interventions (312 children/adolescents participated in one of four interventions):
Duration: 28 days |
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Outcomes |
Relevant outcomes:
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Notes |
ClinicalTrials.gov identifier: NCT00735371 Authors' affiliation: university and pharmaceutical industry Study funding: pharmaceutical industry *Numbers are based on participants included in the safety analysis |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Sequence generated by a web‐based computer system |
Allocation concealment (selection bias) | Low risk | Allocation concealment ensured using the web‐based computer system and third party, which serially numbered treatment bottles for each participant |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Moderate attrition (16%). However, 98% of randomized children/adolescents included in primary efficacy analysis. Reasons for dropouts provided |
Selective reporting (reporting bias) | Low risk | Data provided on all outcomes listed in the registered protocol. Study appears to be free of selective reporting |
Other bias | Low risk | Study appears to be free of other biases |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Blinding of participants and personnel not described |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Blinding of outcome assessment not described |