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

NCT00141050.

Study name Public title: Safety and efficacy study of dexmethylphenidate in children with ADHD
Scientific title: as above
Methods Randomised controlled double‐blind, cross‐over trial
Study duration: not reported
Participants Sample size (actual): 90
Inclusion criteria
  • DSM‐IV diagnosis of ADHD

  • Male and female participants aged 6‐12 years


Exclusion criteria
  • Inability to understand or follow instructions

  • Is pregnant

  • Diagnosis of tic disorder

Interventions
  • d‐MPH (2 unspecified doses)

  • MPH (2 unspecified doses)

  • Placebo

Outcomes ADHD symptoms
  • Reduction of symptoms in attention and deportment assessed at 0.5, 1, 2, 3, 4, 6, 8, 10, 11, and 12 h post‐dose


Total number of serious AEs
  • Safety and tolerability. Scale/measurement methods and timing of outcome assessment not reported


General behaviour
  • Parent's assessment of patient behaviour across all treatment periods as measured by change from baseline


Non‐serious AEs
  • Safety and tolerability. Scale/measurement methods and timing of outcome assessment not reported

Starting date May 2005 (registration date). Starting date not reported
Contact information Name: Matthew Brams, MD (Principal Investigator)
Affiliation: Bayou City Research
Notes Sponsor: Novartis Pharmaceuticals
Declaration of interest: not reported