Konrad 2005.
Study characteristics | ||
Methods | Cross‐over trial with 2 interventions:
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Participants | Number of participants screened: not stated Number of participants included: 44 (37 boys (84%), 7 girls (16%)) Number of participants followed up: 44 Number of withdrawals: not stated Diagnosis of ADHD: DSM‐IV (combined type 100%) Age: mean 10.3 years (SD 1.9, range 8‐12) IQ: mean 98.1 MPH‐naive: not stated Ethnicity: not stated Country: Germany Setting: inpatient ward Comorbidity: not stated Comedication: no Other sociodemographics: none Inclusion criteria
Exclusion criteria
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Interventions | Participants were randomly assigned to 1 of 6 possible drug condition orders of LD‐MPH 0.25 mg/kg or HD‐MPH 0.5 mg/kg and placebo Mean MPH dosage: 9.4 mg (SD 2.3) for the 0.25‐mg/kg dose; 18.6 mg (SD 5.3) for the 0.50‐mg/kg dose Administration schedule: not stated Time points: not stated Duration of each medication condition: 2 days Washout before trial initiation: not stated Medication‐free period between interventions: no Titration period: before testing, all children were given 0.30 mg/kg MPH each day for ≥ 1 week to ascertain tolerance Treatment compliance: not stated. Within the 6‐day protocol, the order of drug conditions was randomly assigned, with the restriction that the high dose never occurred right after placebo |
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Outcomes |
ADHD symptoms
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Notes | Sample calculation: not stated Ethics approval: yes; informed parental consent was obtained for all participants, and the trial was approved by the Medical Ethical Committee of the University Key conclusions of trial authors
Inclusion of MPH responders only/exclusion of MPH non‐responders/children who have previously experienced AEs while taking MPH before randomisation: yes; before testing, all children were given 0.30 mg/kg MPH each day for ≥ 1 week to ascertain tolerance Any withdrawals due to AEs: not stated Funding source: provided through a grant from the German Research Foundation (DFG grant: KFO112–TP5) Email correspondence with trial author: July 2015. Email sent to trial author to ask for additional information, but we have received no reply |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Within the 6‐day protocol, the order of drug conditions was randomly assigned, with the restriction that the high dose never was given immediately after placebo |
Allocation concealment (selection bias) | Unclear risk | Not stated |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Active medication and placebo were prepared by a trial protocol physician who was not involved in the assessment. All capsules were identical opaque gelatin capsules and were administered in a double‐blind manner |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not stated |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Not stated Selection bias (e.g. titration after randomisation → exclusion of MPH non‐responders or placebo responders): no |
Selective reporting (reporting bias) | Unclear risk | No protocol identified |