Autism spectrum disorders
Conditions
Interventions
Administration of 48 IU/day intranasal oxytocin for twice per day, six weeks
Intranasal administration of placebo for twice per day, six weeks
Sponsors
Department of Neuropsychiatry, The University of Tokyo Hospital
Kanazawa University Hospital, Nagoya University Hospital, University of Fukui Hospital
Eligibility
Sex/Gender
Male
Inclusion criteria
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
Exclusion criteria
Exclusion criteria: 1) Primary psychiatric diagnosis other than inclusion criteria 1) 2) Current instability due to a comorbid psychiatric diagnosis 3) History of changes in medications or medication doses of psychotropics within one month of randomization 4) Under current treatment with psychotropics more than two categories 5) Under current treatment with atomoxetine or methylphenidate 6) History of continual treatment of oxytocin 7) History of sensitivity to oxytocin 8) History of seizures or traumatic brain injury with loss of consciousness for longer than 5 minutes 9) History of alcoholics or substance abuse or addiction
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in scores of social reciprocity in Autism Diagnostic Observation Schedule administered just before and after double blind treatment period | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactHidenori Yamasue
The University of Tokyo Hospital Department of Neuropsychiatry
Outcome results
None listed