Intranasal Oxytocin for Autism Spectrum Disorder and Comorbid Severe Intellectual Disabilities:open-label study

Intranasal Oxytocin for Autism Spectrum Disorder and Comorbid Severe Intellectual Disabilities:open-label study - Intranasal Oxytocin for Autism Spectrum Disorder and Comorbid Severe Intellectual Disabilities

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000024339

Enrollment

Registered

2016-10-07

Start date

2016-11-24

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autism spectrum disorder severe intellectual disabilities

Interventions

8 weeks administration of intranasal oxytocin(16IU/dose)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Autism Spectrum Disorders with behavioral problem ABC-J irritability subscale 18 points or more CGI-S 4 points(Moderatory ill) or more moderatory,severe,profound intellectual disabilities self-standing position possible inpatient

Exclusion criteria

Exclusion criteria: CARS-TV less than 30 points self-standing position impossible Weighing less than 20kg History of status epilepticus Possibility of pregnancy Body exhaustion and advanced inspection value or more

Design outcomes

Primary

Measure	Time frame
After 8 weeks administration of intranasal oxytocin The Japanese version of the RBS-R(Repetitive Behavior Scale-Revised)(stereotyped,self-injurious)	—

Secondary

Measure	Time frame
The Japanese version of the RBS-R(Repetitive Behavior Scale-Revised)(compulsive,ritualistic,sameness,restricted interests) The Japanese version of the Aberrant Behavior Checklist(Illitability) The Japanese version of the Sensory Profile Short Version CGI-S CGI-I plasma oxytocin ,salivary oxytocin	—

Countries

Japan

Contacts

Public ContactChie Aita

National Hospital Organization Hizen Psychiatric Center medical office

ai-chie@po.bunbun.ne.jp0952-52-3231

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026