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

Pelham 1993a.

Study characteristics
Methods Cross‐over trial with 2 interventions:
  • MPH 0.3 mg/kg and 0.6 mg/kg

  • placebo


Phases: 3
Participants Number of participants screened: not stated
Number of participants included: 31.
Number of participants followed up: 31 (all boys)
Number of withdrawals: 0
Diagnosis of ADHD: DSM‐III‐R (therefore no subtype)
Age: mean 98.8 months (approximately 8.2 years; range 5.42‐9.92)
IQ: mean 110.7 (range not stated)
MPH‐naive: not stated
Ethnicity: white (93.5%), African American (6.5%)
Country: USA
Setting: hospital (Summer Treatment Program)
Comorbidity: ODD (32%), CD (48%)
Comedication: not stated
Other sociodemographics: none
Inclusion criteria
  • Boys with ADHD attending a Psychiatric Institute and Clinic Summer Treatment Program


Exclusion criteria
  • None described

Interventions Participants were randomly assigned to 1 of 3 possible drug condition orders of 0.3 mg/kg and 0.6 mg/kg MPH and placebo
Mean MPH dosage (SD): low 8.1 mg (range 5‐15); high 16.0 mg (range 10‐22.5)
Administration schedule: twice/d morning and midday; conditions were changed daily over 6 weeks
Duration of each medication condition: 2 weeks overall (individual treatment condition 1 day)
Washout before trial initiation: not described
Titration period: none
Treatment compliance: not reported
Outcomes ADHD symptoms
  • Teachers rated inattention/overactivity daily with the IOWA CTRS

Notes Sample calculation: no
Ethics approval: not stated
Key conclusion of trial authors
  • Relatively small incremental value was gained by the higher dose of medication or by the addition of behaviour modification compared with the effects of the low dose of MPH


Inclusion of MPH responders only/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 declared
Email correspondence with trial author: June 2014. Emailed trial author to ask for additional information but have received no response
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Referred to as a randomised trial but sequence generation not described
Allocation concealment (selection bias) Unclear risk Not described
Blinding of participants and personnel (performance bias)
All outcomes Low risk Capsules were identically packaged
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk Referred to as double‐blind but not described
Incomplete outcome data (attrition bias)
All outcomes Low risk Appears to be 100% follow‐up
Selection bias (e.g. titration after randomisation → exclusion): no
Selective reporting (reporting bias) Unclear risk Protocol not identified