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. 2021 Feb 14;2021(2):CD013457. doi: 10.1002/14651858.CD013457.pub2

NCT00198120.

Study name Public title: Safety and effectiveness of D‐Cycloserine in children with autism
Scientific title: A randomized controlled trial of D‐cycloserine in autism
Methods Study design: randomised, double‐blind controlled trial
Country: USA
Study location: Riley Hospital for Children, Christian Sarkine Autism Treatment Center, Indianapolis, Indiana
Participants 80 participants (age range = 3 to 12 years)
Interventions Experimental intervention: D‐cycloserine
  • Administration: 0.6 mg/kg/day in week 1; 1.1 mg/kg/day in week 2; 1.7 mg/kg/day in weeks 3‐8


Control intervention: placebo
  • Administration: same dosing schedule and capsule strength

Outcomes Primary outcome: core symptoms of ASD, social and communication impairment, measured by the Lethargy subscale of the Aberrant Behavior Checklist (ABC)
Primary outcome: non‐core symptoms of ASD, measured by the Clinical Global Impression‐Improvement (CGI‐I) scale
Starting date February 2004
Contact information Principal investigator: Christopher J McDougle, MD
Affiliation: Indiana University School of Medicine
Telephone: 781‐860‐1783
Email: cmcdougle@partners.org
Notes Sponsorship source: the study was funded by Indiana University.
Comment: recruitment completed. No results posted on the trial register (clinicaltrials.gov/ct2/show/NCT00198120). The investigator did not respond to any of the three emails that we sent requesting further details on the trial.

ASD: autism spectrum disorder.