Autism spectrum disorders
Conditions
Interventions
Administration of 48 IU/day intranasal oxytocin for twice per day, six weeks. followed by intranasal administration of placebo for twice per day, six weeks.
Intranasal administration of placebo for tw
Sponsors
Department of Neuropsychiatry, Graduate School of Medicine, University of Tokyo
Showa University School of Medicine
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1) Diagnosed with autistic disorder or Asperger's disorder or pervasive developmental disorder not-otherwise-specified 2) Verbal IQ above 85 and Full IQ above 80 measured with Wechsler Ault Intelligent Scale-Revised
Exclusion criteria
Exclusion criteria: 1) History of allergy for oxytocin 2) History of seizures or traumatic brain injury with any known cognitive consequences or loss of consciousness for more than five minutes 3) History of substance abuse or addiction 4) Current instability of comorbid psychiatric symptoms 5) Having contraindication of MR-scanning
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes from baseline to post-administration (6 and 12 weeks after the start) on the ADOS (Autism Diagnostic Observation Schedule) and CARS 2 (Childhood Autism Rating Scale 2) . | — |
Secondary
| Measure | Time frame |
|---|---|
| Psychological paradigms to test social cognition and behavior, and changes in eye-tracking and functional-MRI signal during the psychological paradigms. Metabolites levels in the medial prefrontal cortex measured with proton magnetic resonance spectroscopy. Scores of Autism Spectrum Quotient, Social Responsiveness Scale, Clinical Global Impressions, Global Assessment of Functioning, Repetitive Behavior Scale, Quality of Life questionaire, State–Trait Anxiety Inventory, Center for Epidemiologic Studies Depression Scale, Barratt Impulsiveness Scale. | — |
Countries
Japan
Outcome results
None listed