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. 2018 May 10;2018(5):CD012069. doi: 10.1002/14651858.CD012069.pub2

Winsberg 1982.

Methods A non‐randomised, double‐blind cross‐over trial with fixed doses of methylphenidate given twice a day for a week each in the following schedule:
  1. Placebo

  2. 0.25 mg/kg

  3. 0.50 mg/kg

  4. 1.0 mg/kg

  5. Placebo

Participants Number of participants screened: not stated
Number of participants included: 25
Participants were administered successive 5 1‐week treatment conditions of fixed oral dose given twice daily
Number of participants followed up: 20
Number of withdrawals: 5
Diagnosis of ADHD: DSM‐III (subtype: not stated)
Age: mean 9.27, range 6.7‐12.1
IQ: mean 98.2 (14.2)
Sex: 25 males
Methylphenidate‐naïve: not stated
Ethnicity: not stated
Country: USA
Comorbidity: not stated
Comedication: not stated
Sociodemographics: not stated
 Inclusion criteria
  1. ADHD according to DSM‐II criteria

  2. Rating by teacher of ≥ 2.5 on either the hyperactivity or aggressivity factor of the Conners Teacher Rating Scale (TRS)


Exclusion criteria
  1. Rating by the teacher < 2.5 during the placebo period 1 on the TRS (exclusion of placebo responders)

Interventions Participants were administered successive 5 1‐week treatment conditions of fixed oral doses given twice daily according to the following order: placebo 1; 0.25 mg/kg; 0.50 mg/kg; 1.00 mg/kg; placebo 2
Methylphenidate type: not stated
Duration of intervention: 5 weeks
Washout: not stated
Titration period: none
Treatment compliance: not stated
Outcomes Non‐serious adverse events:
Treatment‐emergent side effects, weight, blood pressure measured at the end of each treatment period (after 1 week intervention). Blood pressures were obtained 2 hours following the administration of the oral dose
Notes Sample calculation: not stated
Ethics approval: not stated
Funding/vested interests/authors' affiliations: not stated
Key conclusions from study authors: teacher and parents ratings showed increased improvement in social behaviour as a function of methylphenidate dose. No drug effects were obtained on cognitive performance. Methylpenidate plasma concentrations were significantly associated with oral dose and with measures of social behaviour. No relationship was found with cognitive behaviour. Side effects at the largest dose were severe enough to require discontinuation of treatment for 5 children, but were relatively mild for the rest of the children
 Supplemental information requested through personal email correspondence with authors in September 2013. Not able to get supplemental information regarding data on side effects, and therefore we cannot use the data in the meta‐analyses but only report them as part of a weighted mean (Hungund 2013 [pers comm])