Skip to main content
. 2023 Mar 27;2023(3):CD009885. doi: 10.1002/14651858.CD009885.pub3

Pelham 2002.

Study characteristics
Methods Cross‐over trial with 2 interventions:
  • MPH

  • placebo

Participants Number of participants screened: not stated
Number of participants included: 136 (all boys)
Number of participants followed up: 136
Number of withdrawals: 0
Diagnosis of ADHD: DSM‐III‐R (therefore no subtype)
Age: mean 9.7 years (range 7.6‐12.7)
IQ: mean 104.5
MPH‐naive: not stated
Ethnicity: white (81%), African American (15%)
Country: USA
Setting: Summer Treatment Program
Comorbidity: ODD (53%), CD (24%)
Comedication: not stated
Other sociodemographics: median family income: USD 25,000, (range USD 10,000 to > USD 100,000)
Inclusion criteria
  • Boys attending a psychiatric institute and clinic intensive Summer Treatment Program over 8 weeks


Exclusion criteria
  • Not stated

Interventions Participants were randomly assigned to 1 of 2 possible drug condition orders of 0.3 mg/kg MPH and placebo
Mean MPH dosage: 10 mg (SD 2.7)
Administration schedule: twice daily at 7:45 am and 11:45 am
Duration of each medication condition programme: 12 days (order randomly assigned daily over 6 weeks, doses administered over week days, except on Fridays); follow‐up: 30 days
Washout before trial initiation: 2 weeks medication‐free baseline in programme, unclear for follow‐up
Titration period: none
Treatment compliance: not reported
Outcomes ADHD symptoms
  • Daily ratings of inattention/hyperactivity using IOWA CRS completed by counsellor

  • Daily ratings of inattention/hyperactivity using IOWA CRS completed by teacher


General behaviour
  • Daily ratings of oppositional defiant behaviour using IOWA CRS completed by counsellor

  • Daily ratings of oppositional defiant behaviour using IOWA CRS, completed by teacher

Notes Sample calculation: no
Ethics approval: yes
Comment from trial authors
  • Boys were told 50% of the time whether they were receiving placebo or medication and incorrectly 50% of the time; all boys received behavioural interventions over the course of the programme


Key conclusion of trial authors
  • Expectancy (of treatment effectiveness) did not improve behaviour; only active medication improved behaviour


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: NIMH (Grant MH48157)
Email correspondence with trial authors: June 2014. Emailed trial authors to ask for additional information but have not received a reply
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 Capsules were identical
Blinding of outcome assessment (detection bias)
All outcomes Low risk Raters were blinded to medication condition
Incomplete outcome data (attrition bias)
All outcomes Unclear risk All of the outcomes used for this review are reported for 133 of the 136 boys. The reason for the missing data is not stated.
Selection bias (e.g. titration after randomisation → exclusion): Unclear
Selective reporting (reporting bias) Unclear risk Although measures were rated daily, how data were aggregated/reported as a single result per phase is not clear.