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

DuPaul 1996.

Study characteristics
Methods 4‐week, double‐blind, placebo‐controlled, cross‐over trial in which participants were randomly assigned to 3 doses of MPH:
  • 0.16 mg/kg

  • 0.29 mg/kg

  • 0.42 mg/kg

  • placebo

Participants Number of participants screened: not stated
Number of participants included: 24 (19 boys, 5 girls)
Number of participants followed up: 24
Number of withdrawals: 0
Diagnosis of ADHD: DSM‐III‐R (subtype not stated)
Age: mean 11.09 years (range 9‐15)
IQ: > 70
MPH‐naive: not stated
Ethnicity: white (100%)
Country: USA
Setting: outpatient clinic
Comorbidity: ODD (21%), CD (% not reported)
Comedication: not stated
Other sociodemographics: children were primarily from lower‐middle class and middle class families
Inclusion criteria
  • Parent and/or teacher referral to an outpatient ADHD clinic due to reported problems with inattention, impulsivity and/or overactivity

  • Parent interview indicating that child met DSM‐III‐R (American Psychiatric Association, APA 1987) criteria for ADHD

  • Independent diagnosis of ADHD by psychologist and paediatrician using DSM‐III‐R criteria for ADHD

  • Parent or teacher ratings on the Attention problem scale of the CBCL (Achenbach 1991), resulting in a T score ≥ 65 (i.e. 1.5 SD above the mean)

  • ≥ 9 years old and able to read self‐report questionnaires independently


Exclusion criteria
  • Evidence of mental disability, gross sensory or motor disabilities, seizure disorder, autism, psychosis, tic disorders or Tourette’s syndrome, or significant cardiac problems

  • Currently receiving psychotropic medication

Interventions Participants were randomly assigned to 1 of 6 possible drug condition orders of low‐ (0.16 mg/kg; SD 0.08), moderate‐ (0.29 mg/kg; SD 0.11 kg) and high‐dose (0.42 mg/kg; SD 0.14) MPH and placebo
Administration schedule: twice/d, morning, noon
Duration of each medication condition: 1 week
Washout before trial initiation: not stated
Titration period: none
Treatment compliance: no participant was removed from the investigation for non‐compliance (e.g. > 1 day of failure to administer medication as scheduled)
Outcomes ADHD symptoms
  • ADHD‐RS: teacher and parent ratings


Non‐serious AEs
  • Barkley Side Effects Rating Scale (17 items, 0 = absent, severity rated from 0‐9): rated by participants at the end of each dosage condition

Notes Sample calculation: no information
Ethics approval: Human Subjects Research Board at the University of Massachusetts Medical Center
Comments from trial authors
  • Conclusions based on present findings are limited by several factors

  • Among others, sample size may have diminished power to detect MPH effects on key variables, especially analyses of side‐effect ratings

  • Also results are generalisable only to children with ADHD between 9 and 15 years of age


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: not stated
Email correspondence with trial authors: January 2013‐August 2013. Emailed first trial author regarding additional information. Not able to get all data requested, as trial author no longer has these data
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Children were randomly assigned to 1 of 6 possible orders of MPH dosage
Allocation concealment (selection bias) Low risk Medication was prepared by the hospital pharmacy in increments of 5 mg and packaged within opaque gelatin capsules
Blinding of participants and personnel (performance bias)
All outcomes Low risk Participants, their parents and teachers and the research assistant in charge of collecting data were blinded to the order of medication
Blinding of outcome assessment (detection bias)
All outcomes Low risk Participants, their parents and teachers and the research assistant in charge of collecting data were blinded to the order of medication
Incomplete outcome data (attrition bias)
All outcomes Low risk No
Selection bias (e.g. titration after randomisation → exclusion): no
Selective reporting (reporting bias) Low risk No indication of reporting bias. Analyses on all dependent measures in the trial are reported in the article