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

NCT00198120.

Study name Safety and effectiveness of D‐cycloserine in children with autism
Methods 8‐week parallel trial of D‐cycloserine versus placebo
Participants Inclusion criteria:
  • aged 3‐12 years

  • clinical diagnosis of autism based on DSM‐IV

  • ABC‐lethargy subscale of ≥ 13


Exclusion criteria:
  • severe or profound intellectual disability

  • weight < 11 kg

  • other neurodevelopmental disorders

  • any psychiatric disorders requiring treatment

  • significant renal, hepatic, or cardiovascular disorders


Setting/location: assumed to be in the USA
Sample size: target sample size is 80
Interventions Intervention (D‐Cycloserine) for 8 weeks: maximum 1.7 mg/kg/day
Comparator (placebo) for 8 weeks: equivalent placebo
Outcomes No relevant outcomes
Starting date Trial registry last updated 2016
Contact information Name: Christopher J McDougle
Contact details: not provided
Notes Source of funding: Indiana University
Conflicts of interest: unclear