autism spectrum disorders (ASD)
Conditions
Interventions
Continuous administration of placebo
Continuous administration of intranasal low-dose oxytocin
Continuous administration of intranasal high-dose oxytocin
Sponsors
Department of Neuropsychiatry, Faculty of Medical Sciences, University of Fukui
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with autism spectrum disorders (ASD) based on the classifications in the diagnostic and statistical manual of mental disorders (DSM-IV) and standardized criteria using the diagnostic interview for social and communication disorders (DISCO).
Exclusion criteria
Exclusion criteria: 1. Children less than 15 years old. 2. Participants were excluded if they had a history of major medical or neurological illness including epilepsy, significant head trauma, or a lifetime history of alcohol or drug dependence.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical Global Impression (CGI; CGI-Severity scale, CGI-Improvement scale) Interaction Rating Scale Advanced (IRSA) | — |
Secondary
| Measure | Time frame |
|---|---|
| Blood smple (plasma oxytocin concentration, sex hormones, oxytocin receptor polymorphism) aberrant behavior checklist (ABC) Zung self-rating depression scale (Zung-SDS) state-trait anxiety inventory (STAI) The 20-item Toronto Alexithymia Scale (TAS-20) eye-tracking BIOPAC magnetic resonance imaging (MRI: functional MRI, T1 weighted images) Near-infrared spectroscopy (NIRS) Electroencephalogram\ Stabilometer Safety | — |
Countries
Japan
Contacts
Public ContactYuko Terazawa
Faculty of Medical Sciences, University of Fukui IRB
Outcome results
None listed