title: The effects of a course of intranasal oxytocin on social behaviors in youth diagnosed with autism spectrum disorders: a randomized controlled trial.
abstract: BACKGROUND
  There is increasing interest in oxytocin as a therapeutic to treat social deficits in autism spectrum disorders (ASD). The aim of this study was to investigate the efficacy of a course of oxytocin nasal spray to improve social behavior in youth with ASD.
  
  
  METHODS
  In a double-blind, placebo-controlled trial across two Australian university sites between February 2009 and January 2012, 50 male participants aged between 12 and 18 years, with Autistic or Asperger's Disorder, were randomized to receive either oxytocin (n = 26) or placebo (n = 24) nasal sprays (either 18 or 24 International Units), administered twice-daily for 8 weeks. Participants were assessed at baseline, after 4- and 8-weeks of treatment, and at 3-month follow-up. Primary outcomes were change in total scores on the caregiver-completed Social Responsiveness Scale and clinician-ratings on the Clinical Global Impressions-Improvement scale. Secondary assessments included caregiver reports of repetitive and other developmental behaviors and social cognition.
  
  
  BACKGROUND
  Australian New Zealand Clinical Trials Registry www.anzctr.org.au ACTRN12609000513213.
  
  
  RESULTS
  Participants who received oxytocin showed no benefit following treatment on primary or secondary outcomes. However, caregivers who believed their children received oxytocin reported greater improvements compared to caregivers who believed their child received placebo. Nasal sprays were well tolerated and there was no evidence of increased side effects resulting from oxytocin administration.
  
  
  CONCLUSIONS
  This is the first evaluation of the efficacy for a course of oxytocin treatment for youth with ASD. Although results did not suggest clinical efficacy, further research is needed to explore alternative delivery methods, earlier age of intervention, and the influence of caregiver expectation on treatment response.
authors.affiliation: Autism Clinic for Translational Research, Brain & Mind Research Institute, University of Sydney, Sydney, NSW, Australia.
authors.forename: Adam J
authors.initials: AJ
authors.lastname: Guastella
authors.forename: Kylie M
authors.initials: KM
authors.lastname: Gray
authors.forename: Nicole J
authors.initials: NJ
authors.lastname: Rinehart
authors.forename: Gail A
authors.initials: GA
authors.lastname: Alvares
authors.forename: Bruce J
authors.initials: BJ
authors.lastname: Tonge
authors.forename: Ian B
authors.initials: IB
authors.lastname: Hickie
authors.forename: Caroline M
authors.initials: CM
authors.lastname: Keating
authors.forename: Cristina
authors.initials: C
authors.lastname: Cacciotti-Saija
authors.forename: Stewart L
authors.initials: SL
authors.lastname: Einfeld
mesh_terms: D000281:Administration, Intranasal; D000293:Adolescent; D000067877:Autism Spectrum Disorder / Q000188:drug therapy*; D002648:Child; D005260:Female; D006801:Humans; D008297:Male; D009479:Neuropeptides / Q000008:administration & dosage / Q000494:pharmacology*; D010121:Oxytocin / Q000008:administration & dosage / Q000494:pharmacology*; D012919:Social Behavior; D016896:Treatment Outcome
chemical_list: D009479:Neuropeptides; D010121:Oxytocin
keywords: Social cognition; developmental disorder; emotion recognition; neuropeptides; placebo-controlled