Autism spectrum disorder
Conditions
Interventions
After 1-2 weeks of practice period to get used to the procedure of intranasal administration, the placebo is first administered to those assigned to group A for one month. After a washout period of on
Sponsors
United Graduate School of Child Development, Osaka University
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. The diagnosis for ASD was made based on the criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) and further confirmed by the Autism Diagnostic Observation Schedule (ADOS) at Osaka university hospital. 2. Male 3. Having IQ/DQ between 35-75 assessed in the preceding one year. 4. The age of six - ten years old (1st-4th grade at elementary school) at the day written informed consent for participation is obtained. 5. Parents or legal guardians of the participant provide written informed consent for participation.
Exclusion criteria
Exclusion criteria: 1. Comorbid cardiovascular disease or renal disease 2. History of allergy to oxytocin 3. Female 4. Patients who has used the intranasal oxytocin in the past 5. Responsible doctors judged the trial inappropriate for the patient.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| SRS total score Adverse events Blood pressure,body weight Serum Na concentration, serum osmolality | — |
Secondary
| Measure | Time frame |
|---|---|
| Global Assessment of Functioning (GAF) SRS subscale scores CBCL total score, externalizing score, internalizing score, subscale scores. ABC-J subscale scores | — |
Countries
Japan
Contacts
Public ContactMasako Taniike
Osaka University Department of Child Development
Outcome results
None listed