Swanson 1998.
Study characteristics | ||
Methods | Randomised, double‐blind, cross‐over trial with 6 interventions:
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Participants | Number of participants screened: 36 Number of participants included: 33 (26 boys, 7 girls) Number of participants followed up: 29 Number of withdrawals: 4 Diagnosis of ADHD: DSM‐IV (subtype not stated) Age: mean 10.58 years (range 7‐14) IQ: > 80 MPH‐naive: 0% Ethnicity: not stated Country: USA Setting: outpatient clinic (laboratory classroom) Comorbidity: none Comedication: none Other sociodemographics: none Inclusion criteria
Exclusion criteria
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Interventions | Participants were randomly assigned to 1 of 36 possible drug condition orders of unknown dose of MPH, placebo and 4 doses of MAS (Adderall) Mean MPH dosage: not stated Administration schedule: once, morning Duration of each medication condition: 7 days Washout before trial initiation: not stated Medication‐free period between interventions: none Titration period: none Treatment compliance: 30 of 33 participants completed the 7‐week trial |
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Outcomes |
ADHD symptoms
Serious AEs
Non‐serious AEs
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Notes | Sample calculation: no Ethics approval: not stated Comments from trial authors
Key conclusions of trial authors
Exclusion of MPH non‐responders/children who have previously experienced AEs while taking MPH before randomisation: yes; only known MPH responders were included Any withdrawals due to AEs: no, not in the MPH or placebo group (2 in different MAS groups) Funding source: grant from Richwood Pharmaceutical Company Email correspondence with trial authors: January 2014. No reply has been received |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Latin‐square design (with provisions for 36 participants) was used to determine the within‐participant order of administration of the 6 medication conditions, so that for each of the first 6 weeks, approximately one sixth of participants would be assigned to each of the 6 conditions. Separate randomisation was used to determine assignment of conditions across participants for week 7, to provide an opportunity to make up missed weeks |
Allocation concealment (selection bias) | Unclear risk | No information |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | For each condition, a pharmacist prepared a set of 7 identical capsules, all containing placebo (lactose), 1 of the 4 doses of MAS or MPH |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No information |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | 30 of 33 participants completed the 7‐week trial; 98% of data were collected as planned. For each individual, missing data (1.1% for SKAMP, 0% for Stimulant Side Effects) were replaced by the average of values from adjacent time points (or adjacent values for session 1 or 6). Selection bias (e.g. titration after randomisation → exclusion of MPH non‐responders or placebo responders): no |
Selective reporting (reporting bias) | Unclear risk | No protocol available |