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Effects of long-term administration of intranasal oxytocin on autism spectrum disorders

Effects of long-term administration of intranasal oxytocin on autism spectrum disorders - Effects of long-term administration of intranasal oxytocin on autism spectrum disorders

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000009075
Enrollment
40
Registered
2012-11-01
Start date
2012-11-01
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 Pervasive developmental disorders

Interventions

In Arm 1, the subjects will receive 24IU/dose of intranasal oxytocin (Syntocinon Nasal Spray, NOVARTIS) administration twice daily for one month followed by one week washout period.Then they will rece

Sponsors

Osaka University Hospital
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: All participants will be recruited from the outpatients of Osaka Univercity hospital if they meet the inclusion criteria as follows;1) having clinical diagnosis for autism spectrum disorders as assessed by use of DSM-4-TR (Text Revision of the Diagnostic and Statistical Manual of Mental Disorders,4th edition),and 2) having IQ between 35-75.

Exclusion criteria

Exclusion criteria: We will exclude patients with cardio vascular disease.

Design outcomes

Primary

MeasureTime frame
The outcome measures are Abberant Behavior Checklist(ABC),Child Behavior Checklist(CBCL),Social Responsiveness Scale(SRS) completed by the caregivers and eye tracking tested before the administration of nasal oxytocin and at the end of each term(placebo or oxytocin). In addition,we will analyze mutations of CD38.

Secondary

MeasureTime frame
The second outocome measures are blood pressure,urine osmolarity,urine sodium concentration and oxytocin concentration of his second urine in the morning.They are measured every time the participant comes to the hospital during the trial.

Countries

Japan

Contacts

Public ContactIkuko Hirata

Osaka University Graduate School of Medicine Department of Pediatrics

masako@kokoro.med.osaka-u.ac.jp06-6879-3863

Outcome results

None listed

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