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

NCT00414921.

Study name Public title: Preschool supplement to clonidine in ADHD (Kiddie‐CAT)
Scientific title: as above
Methods Randomised controlled parallel‐group trial
Study duration: 16 weeks
Participants Sample size (actual): 30
Inclusion criteria:
  • Child with ADHD

  • Child aged 4‐6 years

  • Child attending a structured preschool or daycare


Exclusion criteria
  • Presence of a tic disorder of any kind or a known active heart disease for which it would be unsafe to use the study drugs

  • Presence of pervasive developmental disorder, autism, mental disability, or serious psychiatric illness;

  • Child not attending a structured preschool or daycare

Interventions
  • Clonidine

  • MPH

  • Clonidine plus PH

  • Placebo

Outcomes ADHD symptoms
  • ASQ‐T. Assessed at baseline and at 16 weeks

  • ASQ‐P. Assessed at baseline and at 16 weeks


Quality of life
  • CGAS. Assessed at baseline and at 16 weeks


Non‐serious AEs
  • AEs logs. Assessed at baseline and at 16 weeks

  • Pittsburgh Side Effects Rating Scale. Assessed at baseline and at 16 weeks

  • Vital signs. Assessed at baseline and at 16 weeks

  • ECGs. Assessed at baseline and at 16 weeks

Starting date September 2003
Contact information Only names of primary investigators available: Floyd Randy Sallee, MD/PhD; Oscar Bukstein, MD; Donna Palumbo, PhD; William Pelham, PhD
Notes Sponsor: University of Cincinnati and National Institute of Neurological Disorders and Stroke (NINDS)
Declaration of interests: not reported