A multicenter, parallel group, placebo-controlled, double blind, confirmatory trial of intranasal oxytocin in participants with autism spectrum disorders

INTERVENTION: Administration of 48 IU/day intranasal oxytocin for twice per day, six weeks Intranasal administration of placebo for twice per day, six weeks CONDITION: Autism spectrum disorders PRIMARY OUTCOME: Changes in scores of social reciprocity in Autism Diagnostic Observation Schedule administered just before and after double blind treatment period SECONDARY OUTCOME: Changes in scores of communication and restricted and repetitive behavior in Autism Diagnostic Observation Schedule administered just before and after double blind treatment period; ; State and Trait Anxiety Inventory and Center for Epidemiologic Studies Depression Scale assessed just before and after double blind treatment period; ; DNA‐methylations analyzed from whole‐genome analysis using peripheral bloods collected just before and after double blind treatment period; ; Eye gaze assessed just before and after double blind treatment period; ; Facial and voice expressions analyzed from videos recorded in every two weeks during trial period; ; Clinical Global Impression and Global Assessment of Functioning assessed in every two weeks during trial period INCLUSION CRITERIA: 1) Diagnosed as autistic disorder or Asperger's disorder or pervasive developmental disorder not‐otherwise‐specified based on DSM‐IV‐TR 2) Exceeded cutoff for qualitative abnormalities in reciprocal social interaction (Domain A) in Autism Diagnostic Interview‐Revised 3) Verbal IQ above 85 and Full IQ above 80 measured with Wechsler Adult Intelligent Scale‐III