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. 2023 Mar 27;2023(3):CD009885. doi: 10.1002/14651858.CD009885.pub3

McInnes 2007.

Study characteristics
Methods Cross‐over trial with 2 interventions:
  • MPH at low, medium and high doses

  • placebo


Phases: 4
Participants Number of participants screened: 17
Number of participants included: 16 (12 boys, 4 girls)
Number of participants followed up: 16
Number of withdrawals: 0
Diagnosis of ADHD: DSM‐IV‐TR (combined (63%), hyperactive‐impulsive (6%), inattentive (31%))
Age: mean 9.2 years (range 7‐12)
IQ: mean 107.7 (range not reported)
MPH‐naive: ~ 80%
Ethnicity: not stated
Country: Canada
Setting: outpatient clinic
Comorbidity: ODD (19%), CD (25%), generalised anxiety disorder (31%)
Comedication: not stated
Other sociodemographics: none
Inclusion criteria
  • Children 7‐12 years of age with ADHD referred to an outpatient neuropsychiatry clinic for evaluation of response to MPH


Exclusion criteria
  • Children with low cognitive performance (IQ < 80)

Interventions Participants were randomly assigned to 1 of 12 possible drug condition orders of low, medium and high MPH and placebo
Mean MPH dosage: LD (mean 0.21 mg/kg to 0.33 mg/kg, SD 0.07 to 0.02); MD (mean 0.31 mg/kg to 0.43 mg/kg, SD 0.09 to 0.03); and HD (mean 0.42 mg/kg to 0.65 mg/kg, SD 0.13 to 0.15) MPH Administration schedule: 1/d at 9:00 am
Duration of each medication condition: 1 day
Washout before trial initiation: 48 h before trial
Titration period: none
Treatment compliance: not stated
Outcomes ADHD symptoms
  • Inattention/overactivity symptoms based on 5/10 items from the IOWA Conners’ Rating Scale, rated by observer 90 to 120 minutes after ingestion of capsule

Notes Sample calculation: no
Ethics approval: yes
Comments from trial authors
  • "With respect to the medication protocol, we cannot predict that similar results would hold with longer‐term treatment with MPH, given that these findings were obtained under a single acute drug challenge"

  • "Our findings for a predominantly male group of children with ADHD may not be generalisable to other groups of children with ADHD, for example, community samples that involve more girls and different rates of occurrence of comorbid conditions"

  • "Small sample size places limitations on conclusions that can be drawn from our findings"


Key conclusions of trial authors
  • Findings provide preliminary evidence that MPH affects higher‐level language comprehension skills, which require sustained attention and mental effort

  • If generalisable to classroom listening skills, these findings have implications for clinicians and teachers involved with children with ADHD


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: The Psychiatric Endowment Fund
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Not described
Allocation concealment (selection bias) Unclear risk Not described
Blinding of participants and personnel (performance bias)
All outcomes Low risk "Multiple blind procedures", capsules identically packaged by pharmacists
Blinding of outcome assessment (detection bias)
All outcomes Low risk "Examiner, who was kept blind to child’s medication status"
Incomplete outcome data (attrition bias)
All outcomes Low risk No LTFU
Selection bias (e.g. titration after randomisation → exclusion): no
Selective reporting (reporting bias) High risk Symptom data not reported