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

Moshe 2012.

Study characteristics
Methods 2‐week, randomised, double‐blind, cross‐over trial with 2 interventions:
  • MPH

  • placebo

Participants Number of participants screened: 78
Number of participants included: 57 (all boys)
Number of participants followed up: 57
Number of withdrawals: 0
Diagnosis of ADHD: DSM‐IV (combined and hyperactive‐impulsive (53%), inattentive (47%))
Age: mean 9.5 years (range 7‐12)
IQ: normal
MPH‐naive: 100%
Ethnicity: not stated
Country: Israel
Setting: outpatient clinic
Comorbidity: no
Comedication: no
Other sociodemographics: representing all socioeconomic strata
Inclusion criteria
  • Male

  • 7‐12 years

  • ADHD, DSM‐IV

  • Drug‐naive and with no other intervention

  • Suitable candidate for MPH treatment

  • Attention disorder was associated with a significant effect on daily life, and scores on 1 of the Attention subscales of both parent and teacher questionnaires were 1.5 SD or above the mean as suggested in clinical guidelines


Exclusion criteria
  • Chronic psychiatric and neurological disorders, for example, OCD

  • Tourette's syndrome

  • Seizure disorder

  • Severe learning disability (defined by special education enrolment)

  • Definitive primary diagnosis of an anxiety disorder (DSM‐IV) or sensory impairment

Interventions Participants were randomly assigned to 1 of 2 possible drug condition orders of 0.3 mg/kg IR‐MPH and placebo
MPH dose range: 6 mg‐12 mg
Administration schedule: once daily
Duration of each medication condition: 1 week
Washout before trial initiation: no (drug‐naive)
Titration period: no
Treatment compliance: not stated
Outcomes ADHD symptoms
  • CTRS, revised: weekly (after each intervention period)

Notes Sample calculation: yes
Ethics approval: yes
Comments from trial authors
  • Results of the present study should be interpreted with caution

  • As only boys were included, the results might not be valid for girls

  • Children were clinic referrals and therefore might not be representative of the population of children with ADHD at large


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: none
Email correspondence with trial authors: April‐October 2013. We received supplemental data from trial authors
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Randomly assigned with a table of random numbers
Allocation concealment (selection bias) Low risk Placebo (prepared as look‐alike capsules by the hospital pharmacy)
Blinding of participants and personnel (performance bias)
All outcomes Low risk Double‐blind
Blinding of outcome assessment (detection bias)
All outcomes Low risk Double‐blind
Incomplete outcome data (attrition bias)
All outcomes Low risk No withdrawals
Selection bias (e.g. titration after randomisation → exclusion): no
Selective reporting (reporting bias) Low risk No indication of selective reporting. According to trial authors, all planned outcomes were assessed and analysed