Stoner 1994.
Study characteristics | ||
Methods | 2 n‐of‐1, double‐blind, placebo‐controlled, cross‐over, randomised controlled trial. Both cases received 4 levels of the following:
After the double‐blind trial, the code was broken, and the best dose was administered to the participant. Follow‐up data on the best dose were also measured. Follow‐up data were recorded anecdotally for the first case (Dan) and systematically for the second case (Bill) |
|
Participants | Number of participants screened: 2 boys Number of participants included: 2 Number of participants followed up: 2 Number of withdrawals: none Diagnosis of ADHD: DSM‐III‐R (subtype not stated) Age: Dan 9 years, Bill 13 years IQ: not stated MPH‐naive: 100% Ethnicity: not stated Country: USA Setting: not stated Comorbidity: not stated Comedication: not stated Other sociodemographics: none Inclusion criteria
Exclusion criteria
|
|
Interventions | Participants were randomly assigned to different orders of 3 doses of MPH and placebo Mean MPH dosage: not relevant Administration schedule: once daily at breakfast Duration of each medication condition: Dan received placebo for 3 days, and 5 days of treatment with 5 mg, 10 mg or 15 mg MPH consecutively. Bill received placebo for 3 days, and 3 days of treatment with 5 mg, 10 mg or 15 mg MPH consecutively Washout before trial initiation: treatment‐naive Medication‐free period between interventions: 24 h between doses Titration period: none Treatment compliance: parents were instructed to initial a monitoring form each time they gave a dose to their child after breakfast. No further description of this was provided Regarding the follow‐up trial: Dan 15 mg; Bill 10 mg (5 mg twice daily) |
|
Outcomes |
General behaviour
Non‐serious AEs
|
|
Notes | Sample calculation: not relevant Ethics approval: not stated Comments from trial authors
Key conclusion of trial authors
Comments 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: National Association of School Psychologists Email correspondence with trial author: January 2014. Wrote to trial author to request additional information regarding ethics approval, intellectual disability, etc., but have not received a response |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | The order of medication levels was determined randomly. In packing the envelopes, 1 of the trial authors arranged the coded envelopes according to the randomly determined order of trials |
Allocation concealment (selection bias) | Low risk | Each medication level was prepared and packed in separate envelopes by a pharmacist |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Each dose of MPH and placebo was ground into a powder, mixed with an inert compound, and was sealed in a small coloured drug capsule, so that doses were identical in appearance and taste. Thus, the pharmacist, the data collectors, the participants and their families did not know the order of drug administration |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Each dose of MPH and placebo was ground into a powder, mixed with an inert compound, and was sealed in a small coloured drug capsule, so that doses were identical in appearance and taste. Thus, the pharmacist, the data collectors, the participants and their families did not know the order of drug administration |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All data were provided Selection bias (e.g. titration after randomisation → exclusion of MPH non‐responders or placebo responders): no |
Selective reporting (reporting bias) | Unclear risk | No protocol was identified, and no answer was received from the trial author |