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

Gabis 2019.

Methods 12‐week cross‐over trial of donepezil versus placebo
Participants Inclusion criteria:
  • clinical diagnosis of ASD or PDD‐NOS

  • aged 10‐18 years

  • parental consent provided to participate in the study


Exclusion criteria:
  • any infectious disease, chromosomal abnormalities, metabolic disorders, neurological conditions

  • "use of psychostimulants, anti‐depressants, neuroleptics or anti‐convulsive agents within the past month"

  • brain damage; or significant head injury


Location/setting: Israel
Sample size: target of 84 participants
Number randomised: 60 in total (donepezil + choline (29) or placebo (31))
Number analysed: 48 (intervention (23), placebo (25))
Number and reason for dropouts: 14 were reported to have dropped out ("Six subjects dropped out after the first assessment due to lack of compliance, and three additional subjects subsequently failed to attend follow‐up for the second assessment. Three subjects (one in the placebo group and two in the treatment group) were excluded during treatment due to side effects").
Gender: not reported
Mean age: not reported
IQ: not reported
Concomitant medications: not reported
Previous medications: not reported
Interventions Intervention (donepezil + choline) for 12 weeks: maximum donepezil 5 mg/day taken once daily, choline 250 mg/day (children up to 40 kg) or 500 mg/day (children 40 kg and over)
Comparator (placebo) for 12 weeks: equivalent placebo
Outcomes Primary outcomes: AEs
Secondary outcomes: none reported
Timing of outcome assessments: baseline, weeks 4, 8 and 12 (endpoint)
Notes Study start date: March 2010
Study end date: December 2017
Source of funding: not reported
Conflicts of interest: not reported