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. 2023 Oct 9;2023(10):CD011769. doi: 10.1002/14651858.CD011769.pub2

Handen 2000.

Methods Cross‐over trial of 0.3 mg/kg methylphenidate, 0.6 mg/kg methylphenidate or placebo
Participants Inclusion criteria:
  • while off all psychotropic medication

    • score of ≥ 30 on a parent‐completed CARS

    • diagnosis of autism or PDD‐NOS made by a board‐certified child psychiatrist

    • score of ≥ 15 points on the Hyperactivity Index of the Teacher Conners' Rating Scale


Exclusion criteria: not reported
Location/setting: participants were recruited from either special education programmes, a psychiatric inpatient unit, or intensive day‐treatment programme.
Sample size: 13 in total (cross‐over)
Number of withdrawals/dropouts: 1 person was not included in the analysis; however, reasons were not provided.
Gender: 10 male participants, 3 female participants
Mean age: median 7.4 years
IQ: 3 had severe/profound disability, 5 had moderate intellectual disability, 4 had mild intellectual disability, 1 had average IQ
Baseline ABC‐I or other BoC: not reported
Concomitant medications: not reported
History of previous medications: not reported
Interventions Intervention 1 (0.3 mg/kg methylphenidate for 7 days): 0.3 mg/kg doses of methylphenidate rounded to the nearest 2.5 mg was given 2‐3 times/day for 7 consecutive days. Doses were given at breakfast and 4 h later with lunch.
Intervention 2 (0.6 mg methylphenidate for 7 days): 0.6 mg/kg doses of methylphenidate rounded to the nearest 2.5 mg was given 2‐3 times/day for 7 consecutive days. Doses were given at breakfast and 4 h later with lunch.
Comparator (placebo for 7 days): equivalent placebo doses
Outcomes Primary outcomes:
  • irritability, measured using the ABC‐I subscale (Aman 1985)

  • AEs


Secondary outcomes: not reported
Timing of outcome assessment: not reported
Notes Study start date: not reported
Study end date: not reported
Source of funding: "This research was supported by a grant to the third author from the Fanny Pushin Rosenberg Research Foundation."
Conflicts of interest: none declared