title: Intranasal oxytocin in the treatment of autism spectrum disorders: a review of literature and early safety and efficacy data in youth.
abstract: BACKGROUND
  There is a paucity of treatments targeting core symptom domains in Autism Spectrum Disorder (ASD). Several animal models and research in typically developing volunteers suggests that manipulation of the oxytocin system may have therapeutic potential for the treatment of social deficits. We review the literature for oxytocin and ASD and report on early dosing, safety and efficacy data of multi-dose oxytocin on aspects of social cognition/function, as well as repetitive behaviors and co-occurring anxiety within ASD.
  
  
  METHODS
  Fifteen children and adolescents with verbal IQs≥70 were diagnosed with ASD using the ADOS and the ADI-R. They participated in a modified maximum tolerated dose study of intranasal oxytocin (Syntocinon). Data were modeled using repeated measures regression analysis controlling for week, dose, age, and sex.
  
  
  RESULTS
  Among 4 doses tested, the highest dose evaluated, 0.4 IU/kg/dose, was found to be well tolerated. No serious or severe adverse events were reported and adverse events reported/observed were mild to moderate. Over 12 weeks of treatment, several measures of social cognition/function, repetitive behaviors and anxiety showed sensitivity to change with some measures suggesting maintenance of effect 3 months past discontinuation of intranasal oxytocin.
  
  
  CONCLUSIONS
  This pilot study suggests that daily administration of intranasal oxytocin at 0.4 IU/kg/dose in children and adolescents with ASD is safe and has therapeutic potential. Larger studies are warranted. This article is part of a Special Issue entitled Oxytocin and Social Behav.
authors: Bloorview Research Institute, University of Toronto, 150 Kilgour Road, Toronto, ON, Canada M4G 1R8. Electronic address: eanagnostou@hollandbloorview.ca.
authors: Evdokia
authors: E
authors: Anagnostou
authors: Rush University Medical Center, Department of Psychiatry, 2150 West Harrison Street, Chicago, IL 606103, USA.
authors: Latha
authors: L
authors: Soorya
authors: Bloorview Research Institute, University of Toronto, 150 Kilgour Road, Toronto, ON, Canada M4G 1R8.
authors: Jessica
authors: J
authors: Brian
authors: The Hospital for Sick Children, Dalla Lana School of Public Health, University of Toronto, 555 University Avenue, Toronto, Canada M5G 1X8.
authors: Annie
authors: A
authors: Dupuis
authors: Bloorview Research Institute, University of Toronto, 150 Kilgour Road, Toronto, ON, Canada M4G 1R8.
authors: Deepali
authors: D
authors: Mankad
authors: Bloorview Research Institute, University of Toronto, 150 Kilgour Road, Toronto, ON, Canada M4G 1R8.
authors: Sharon
authors: S
authors: Smile
authors: University of Minnesota, Department of Psychiatry & Pediatrics, 2101 6th Street SE, Minneapolis, MN 55455, USA.
authors: Suma
authors: S
authors: Jacob
mesh_terms: D000281:Administration, Intranasal; D000293:Adolescent; D000818:Animals; D002648:Child; D002659:Child Development Disorders, Pervasive / Q000188:drug therapy* / Q000503:physiopathology; D003071:Cognition / Q000187:drug effects; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D010121:Oxytocin / Q000008:administration & dosage* / Q000009:adverse effects; D010865:Pilot Projects; D011619:Psychotropic Drugs / Q000008:administration & dosage* / Q000009:adverse effects; D012919:Social Behavior; D016896:Treatment Outcome
chemical_list: D011619:Psychotropic Drugs; D010121:Oxytocin
keywords: Autism; Clinical trial; Oxytocin; Social cognition; Social function