Short 2004.
Methods | Single‐center, randomized, double‐blind, placebo‐controlled, cross‐over trial
Country: United States Number of study sites: 1 Statistical methods: per protocol |
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Participants | Sample size: 34* children/adolescents with an ADHD diagnosis according to DSM‐IV criteria Dropouts: NR Psychiatric comorbid conditions: NR Age range: 3 years to 5.9 years Mean age (SD): 5.3 (NR) years Sex: 24 (85%) males ADHD subtype: 5 (17%) inattentive; 23 (83%) hyperactive ‐ impulsive or combined | |
Interventions |
Two conditions (28 children/adolescents participated in one of two conditions)*:
Amphetamine or methylphenidate determined by a physician Duration: 28 days (4 x 7‐day treatment periods) |
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Outcomes |
Relevant outcomes:
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Notes |
ClinicalTrial.gov identifier: not available Authors' affiliations: university Study funding: public funds *Clinical characteristics only presented on children/adolescents included in analysis (n = 28) **The authors did not separate the two active interventions (amphetamine and methylphenidate) in their analysis. We contacted the authors on three occasions to obtain the data on amphetamines only, but we received no response, and therefore outcomes could not be included in the meta‐analysis |
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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) | Unclear risk | Method of allocation concealment not sufficiently described |
Incomplete outcome data (attrition bias) All outcomes | High risk | Reasons for attrition not described. In addition, six participants were dropped from the analysis, and their last data point was not carried forward |
Selective reporting (reporting bias) | Unclear risk | Study protocol not available and the possibility of reporting bias could not be assessed |
Other bias | Low risk | Study appears to be free of other biases |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Intervention and placebo described as identical |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Outcome assessors blinded to order of trial interventions |