Ullmann 1985.
Study characteristics | ||
Methods | 8‐week, cross‐over trial:
Phases: 2
The trial was conducted over 3 years |
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Participants | Number of participants screened: not stated Number of participants included: 86 Number of participants followed up: 86 (67 boys, 19 girls) Number of withdrawals: 0 Diagnosis of ADHD: DSM‐III (ADD (15.1%), ADD‐H (70.9%), other (14.0%)) Age: mean 8.6 years (SD 1.8; range not stated) IQ: > 70 MPH‐naive: not stated Ethnicity: African American (17.4%), other (82.6%) Country: USA Setting: not stated Comorbidity: not stated Comedication: not stated Other sociodemographics: none Inclusion criteria
Exclusion criteria
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Interventions | Participants were randomly assigned to 3 different doses of MPH (0.3 mg/kg, 0.5 mg/kg and 0.8 mg/kg) and placebo Administration schedule: once daily, before school Duration of each medication condition: 1 week Washout before trial initiation: dose taken in the morning to the next day's dose Titration period: 4 weeks Treatment compliance: "compliance were probably high" |
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Outcomes |
ADHD symptoms
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Notes | Sample calculation: no information Ethics approval: no information Comment from trial authors
Key conclusion of trial 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. Ciba‐Geigy provided medication and placebo Email correspondence with trial authors: not able to find first or second trial author's contact information; therefore not able to request supplemental data necessary for meta‐analyses |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Random assignment |
Allocation concealment (selection bias) | High risk | No description; only "methylphenidate in opaque capsules" |
Blinding of participants and personnel (performance bias) All outcomes | High risk | No description |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Teacher rating under blinded conditions |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Data were pooled for a total of 86 participants Selection bias (e.g. titration after randomisation → exclusion): no |
Selective reporting (reporting bias) | Unclear risk | Unable to obtain protocol |