title: A randomized, placebo-controlled trial of D-cycloserine for the enhancement of social skills training in autism spectrum disorders.
abstract: BACKGROUND
  Researchers have demonstrated that d-cycloserine (DCS) can enhance the effects of behavioral interventions in adults with anxiety and enhances prosocial behavior in animal models of autism spectrum disorders (ASD). This study extended upon this background by combining DCS with behavioral social skills therapy in youth with ASD to assess its impact on the core social deficits of ASD. We hypothesized that DCS used in combination with social skills training would enhance the acquisition of social skills in children with ASD.
  
  
  METHODS
  A 10-week, double-blind, placebo-controlled trial of DCS (50 mg) given 30 min prior to weekly group social skills training was conducted at two sites. Children with ASD were randomized to receive 10 weeks (10 doses) of DCS or placebo in a 1:1 ratio.
  
  
  RESULTS
  No statistically significant difference attributable to drug treatment was observed in the change scores for the primary outcome measure, the Social Responsiveness Scale (SRS), total score (p = 0.45), or on secondary outcome measures.
  
  
  CONCLUSIONS
  The results of this trial demonstrated no drug-related short-term improvement on the primary outcome measure, or any of the secondary outcome measures. However, an overall significant improvement in SRS total raw score was observed from baseline to end of treatment for the entire group of children with ASD. This suggests a need to further study the efficacy of the social skills training protocol. Limitations to the current study and areas for future research are discussed.
  
  
  BACKGROUND
  ClinicalTrials.govNCT01086475.
authors.affiliation: Christian Sarkine Autism Treatment Center, Riley Hospital for Children at Indiana University Health, Indiana University School of Medicine Department of Psychiatry, Indianapolis, IN USA.
authors.forename: Noha F
authors.initials: NF
authors.lastname: Minshawi
authors.affiliation: Cincinnati Children's Hospital Medical Center, University of Cincinnati College of Medicine, 3333 Burnet Avenue MLC 4002, Cincinnati, OH 45229 USA.
authors.forename: Logan K
authors.initials: LK
authors.lastname: Wink
authors.affiliation: Cincinnati Children's Hospital Medical Center, University of Cincinnati College of Medicine, 3333 Burnet Avenue MLC 4002, Cincinnati, OH 45229 USA.
authors.forename: Rebecca
authors.initials: R
authors.lastname: Shaffer
authors.affiliation: Christian Sarkine Autism Treatment Center, Riley Hospital for Children at Indiana University Health, Indiana University School of Medicine Department of Psychiatry, Indianapolis, IN USA.
authors.forename: Martin H
authors.initials: MH
authors.lastname: Plawecki
authors.affiliation: David J. Posey, M.D., LLC, Indianapolis, IN USA.
authors.forename: David J
authors.initials: DJ
authors.lastname: Posey
authors.affiliation: Department of Biostatistics, Indiana University School of Medicine, Indianapolis, IN USA.
authors.forename: Hai
authors.initials: H
authors.lastname: Liu
authors.affiliation: Indiana University School of Education, Bloomington, IN USA.
authors.forename: Sarah
authors.initials: S
authors.lastname: Hurwitz
authors.affiliation: Lurie Center for Autism, Departments of Psychiatry and Pediatrics, Massachusetts General Hospital and MassGeneral Hospital for Children, Harvard Medical School, Boston, MA USA.
authors.forename: Christopher J
authors.initials: CJ
authors.lastname: McDougle
authors.affiliation: Christian Sarkine Autism Treatment Center, Riley Hospital for Children at Indiana University Health, Indiana University School of Medicine Department of Psychiatry, Indianapolis, IN USA.
authors.forename: Naomi B
authors.initials: NB
authors.lastname: Swiezy
authors.affiliation: Cincinnati Children's Hospital Medical Center, University of Cincinnati College of Medicine, 3333 Burnet Avenue MLC 4002, Cincinnati, OH 45229 USA.
authors.forename: Craig A
authors.initials: CA
authors.lastname: Erickson
mesh_terms: D000067877:Autism Spectrum Disorder / Q000188:drug therapy* / Q000523:psychology / Q000628:therapy; D001521:Behavior Therapy; D002648:Child; D002675:Child, Preschool; D003523:Cycloserine / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D018690:Excitatory Amino Acid Agonists / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D007398:Interpersonal Relations; D007858:Learning / Q000187:drug effects; D008297:Male; D010290:Parents / Q000523:psychology; D012720:Severity of Illness Index; D066107:Social Skills; D017211:Treatment Failure
chemical_list: D018690:Excitatory Amino Acid Agonists; D003523:Cycloserine
keywords: Autism spectrum disorders; Social deficits; Social skills training; d-cycloserine