Intranasal Oxytocin for Autism Spectrum Disorder and Comorbid Severe Intellectual Disabilities:Open-label long term study

Intranasal Oxytocin for Autism Spectrum Disorder and Comorbid Severe Intellectual Disabilities:Open-label long term study - Intranasal Oxytocin for Autism Spectrum Disorder and Comorbid Severe Intellectual Disabilities:Open-label long term study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000028650

Enrollment

Registered

2017-09-01

Start date

2017-09-06

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

24 weeks administration of intranasal oxytocin(24IU/day)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Autism Spectrum Disorder with behavioral problem ABC-J irritability subscale 18points 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 Weight under 20kg History of status epilepticus possibility of pregnancy Physical exhaustion and advanced inspection value or more

Design outcomes

Primary

Measure	Time frame
After 24 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 Abberrant 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