Garfinkel 1983.
Study characteristics | ||
Methods | Double‐blind, randomised, placebo‐controlled, cross‐over experiment with 4 arms:
Trial lasted 20 weeks; first and last 2 weeks were baseline periods during which no medication was given. Different interventions lasted 3 weeks each (Monday to Friday) with a 7‐day washout between changes in drugs |
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Participants | Number of participants screened: not stated Number of participants included: 12 (all boys) Number of participants followed up: 12 Number of withdrawals: 0 Diagnosis: DSM‐III Age: mean 7.3 years (range 5.9‐11.6) IQ: > 70 MPH‐naive: 50% Ethnicity: not stated Country: USA Setting: outpatient clinic and patient ward. 8 participants were day hospital patients and 4 were inpatients Comorbidity: no Comedication: no comedication during trial period Other sociodemographics: children presented with remarkably similar clinical, family and educational histories. None of the children had localising neurological signs or met criteria for other psychiatric diagnoses Inclusion criteria
Exclusion criteria
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Interventions | Participants were randomly assigned to the different possible drug condition orders of MPH, clomipramine, desipramine and placebo Mean MPH dosage: 18 mg/d Administration schedule: twice/d, morning and lunch Duration of each medication condition: 3 weeks Washout before trial initiation: 2 weeks before trial entry and 7 days between drug conditions Titration period: first week of the drug condition after randomisation Treatment compliance: not stated |
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Outcomes |
ADHD symptoms
General behaviour
Non‐serious AEs
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Notes | Sample calculation: no information Ethics approval: no information Key conclusions of trial authors
Comment from review 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: Ontario Mental Health Foundation Email correspondence with trial authors. October 2013. We obtained supplemental information regarding number of dropouts and SD for CRS. We also wanted other data but were not able to obtain these, as the trial took place several years ago and the data are no longer available |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Children were randomly given MPH, desipramine, clomipramine, placebo. A Latin square was followed to control for the order of presentation of drugs |
Allocation concealment (selection bias) | Low risk | Children were randomly given MPH, desipramine, clomipramine, placebo. A Latin square was followed to control for the order of presentation of drugs |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Participants, parents, attending physicians, teachers, nursing staff and child care workers did not know which medication the child received, ensuring the double‐blind procedure. Medication was added to lactose powder and was placed in identical‐appearing gelatin capsules |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Participants, parents, attending physicians, teachers, nursing staff and child care workers did not know which medication the child received, ensuring the double‐blind procedure. Medication was added to lactose powder and was placed in identical‐appearing gelatin capsules |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | No information Selection bias (e.g. titration after randomisation → exclusion of MPH non‐responders or placebo responders): no |
Selective reporting (reporting bias) | Low risk | No indication of reporting bias |