Biederman 2007a.
Methods | Multi‐center, randomized, double‐blind, placebo‐controlled, cross‐over trial Country: United States Number of study sites: 4 Statistical methods: modified ITT (all randomized children/adolescents who had at least one post‐randomization score on primary outcome measure) | |
Participants | Sample size: 52 children/adolescents with an ADHD diagnosis according to the DSM‐IV‐TR criteria Dropouts: 2 Psychiatric comorbid conditions: NR Age range: 6 years to 12 years Mean age (SD): 9.1 (1.7) years Sex: 33 (64%) males ADHD subtypes: 52 (100%) combined | |
Interventions |
Three interventions (all 52 children/adolescents participated in each of the three interventions):
Duration: 21 days (3 x 7‐day treatment periods) |
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Outcomes |
Relevant outcomes:
Other outcomes:
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Notes | ClinicalTrials.gov identifier: NCT00557011 Authors' affiliation: university and pharmaceutical industry Study funding: pharmaceutical industry *Mixed amphetamine salts ‐ extended release was randomly chosen to represent the amphetamine group in this study for binary outcomes | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Method of sequence generation not described |
Allocation concealment (selection bias) | Low risk | Method of allocation concealment involved pre‐packaged, serially‐numbered drug kits, in which the next participant enrolled received the next available drug kit. Drug kits prepared by a third party |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Although the primary analysis only included trial completers, attrition was low at 4% |
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 |