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The effect of Oxytocin (OT) on social cognition and behaviour in youth with Autism Spectrum Disorders (ASD).

THe effects of Oxytocin in young people with Autism to treat social communication problems

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12609000368235
Enrollment
20
Registered
2009-05-27
Start date
2008-10-03
Completion date
2009-03-13
Last updated
2020-01-13

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

Conditions

None listed

Brief summary

This study tests whether Oxytocin improves the social communication problems in young people with Autism. It is predicted that individuals from the community diagnosed with autism or asperger's disorder who receive a single dose of oxytocin nasal spray will show improved performance on social cognition tests in comparison to performance on these tests under a placebo. Two single session assessment sessions within a two week period are conducted using a crossover design. All subjects, therapists, assessors, and data entry staff are blind to condition.

Interventions

Young people with Autism Spectrum Disorders are given a single dose of oxytocin nasal spray or an identical placebo in a crossover design with a one-week washout period. For children between the age of 12 and 15 we use a 18 International Unit dose, while people between the age of 16 and 20 receive a 24 International Unit dose. Participants receive the nasal spray, wait 45 minutes and complete experimental tasks. Participants return one week later to receive the nasal spray again, wait 45 minute

Young people with Autism Spectrum Disorders are given a single dose of oxytocin nasal spray or an identical placebo in a crossover design with a one-week washout period. For children between the age of 12 and 15 we use a 18 International Unit dose, while people between the age of 16 and 20 receive a 24 International Unit dose. Participants receive the nasal spray, wait 45 minutes and complete experimental tasks. Participants return one week later to receive the nasal spray again, wait 45 minutes and complete the same experimental tasks. On both occasions participants are observed for a period of 1.5 hours while they complete social cognition tasks. These tasks include emotion recognition (Reading the mind in the eyes) as well as eye-tracking when viewing human faces. The entire trial is completed within these two experimental testing sessions.

Sponsors

University of Sydney
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used)

Eligibility

Sex/Gender
Male
Age
12 Years to 20 Years
Healthy volunteers
No

Inclusion criteria

Male youth with a primary diagnosis of Autism or Asperger disorder with a mental age of 12 or higher.

Exclusion criteria

Females, mental age below 12. Chronological age below 12.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026