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The effects of a course of intranasal oxytocin on social behaviors in youth diagnosed with autism spectrum disorders : a randomized controlled trial . 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 . CLINICAL TRIAL REGISTRATION 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 .
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Intervention_Pharmacological
intranasal oxytocin
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Intervention_Pharmacological
oxytocin
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Intervention_Pharmacological
oxytocin nasal spray
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Intervention_Control
placebo-controlled
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Intervention_Pharmacological
oxytocin
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Intervention_Control
placebo
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Intervention_Pharmacological
nasal sprays
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Intervention_Pharmacological
oxytocin
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Intervention_Control
placebo
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Intervention_Pharmacological
oxytocin
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Intervention_Pharmacological
oxytocin
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Outcome_Mental
total scores on the caregiver-completed Social Responsiveness Scale and clinician-ratings on the Clinical Global Impressions-Improvement scale .
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Outcome_Mental
caregiver reports of repetitive and other developmental behaviors and social cognition .
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Outcome_Other
tolerated
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Outcome_Adverse-effects
side effects
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Participant_Age
youth
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Participant_Condition
autism spectrum disorders
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Participant_Condition
autism spectrum disorders ( ASD ) .
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Participant_Condition
ASD
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Participant_Condition
two Australian university sites between February 2009 and January 2012 ,
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Participant_Sample-size
50
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Participant_Sex
male
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Participant_Age
12 and 18 years
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Participant_Condition
Autistic or Asperger 's Disorder