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A randomized, placebo-controlled, double-blind, 2-period cross-over study in youth with autism spectrum disorders evaluating social and repetitive behaviors after four weeks of twice daily-doses of 24IU of intranasally administered oxytocin

Status
Not yet recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-512387-56-00
Enrollment
128
Registered
2024-10-09
Start date
Unknown
Completion date
Unknown
Last updated
2024-10-09

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

Conditions

Autism spectrum disorder

Brief summary

The effect of 24 IU oxytocin delivered intranasally, twice-daily, for four weeks, on social behavior. This will be operationalized as change from baseline on performance on the Social Responsiveness Scale-Second Edition (SRS-2), completed by caregivers of the participants., The effect of 24 IU oxytocin delivered intranasally, twice-daily, for four weeks, on repetitive behavior. This will be operationalized as change from baseline on performance on the Repetitive Behavior Scale-Revised (RBS-R) scale, completed by caregivers of the participants.

Detailed description

The effect of 24 IU oxytocin delivered intranasally, twice-daily, for four weeks, on behavioral inflexibility. This will be operationalized as change from baseline on performance on the Behavioral Inflexibility scale (BIS), completed by caregivers of the research participants

Interventions

Sponsors

Oslo University Hospital HF
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
0 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
The effect of 24 IU oxytocin delivered intranasally, twice-daily, for four weeks, on social behavior. This will be operationalized as change from baseline on performance on the Social Responsiveness Scale-Second Edition (SRS-2), completed by caregivers of the participants., The effect of 24 IU oxytocin delivered intranasally, twice-daily, for four weeks, on repetitive behavior. This will be operationalized as change from baseline on performance on the Repetitive Behavior Scale-Revised (RBS-R) scale, completed by caregivers of the participants.

Secondary

MeasureTime frame
The effect of 24 IU oxytocin delivered intranasally, twice-daily, for four weeks, on behavioral inflexibility. This will be operationalized as change from baseline on performance on the Behavioral Inflexibility scale (BIS), completed by caregivers of the research participants

Countries

Norway

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026