CompletedPhase 2Phase 3ACTRN12609000513213

A course of oxytocin nasal spray (OT) to treat social problems in youth with autism spectrum disorders

A double blind randomised controlled trial of oxytocin nasal spray to treat social problems in autistic youth

Sponsor

University of Sydney

Enrollment

50 participants

Start Date

Feb 18, 2009

Study Type

Interventional

Conditions

Autism Spectrum Disorders

Summary

This study tests whether a course of oxytocin over 8-weeks improves the social communication problems in young people with autistic spectrum disorders. It is predicted that individuals from the community diagnosed with autism or asperger's disorder and within ADOS assessment criteria for autism who receive a course of oxytocin nasal spray will show improved social functioning on self-report, diagnostic and experimental measures, in comparison to participants assigned to placebo admistration. Two single session assessment administered participants. All participants, therapists, assessors, and data entry staff are blind to condition.

Eligibility

Sex: MalesMin Age: 12 YearssMax Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study tests whether a course of oxytocin nasal spray can improve social skills and reduce social difficulties in boys aged 12-18 with autism spectrum disorders. Participants use the spray daily and researchers measure changes in social behaviour over time.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

In a double blind, randomized controlled trial, young people with Autism Spectrum Disorders are randomly assigned to receive an 8-week course of oxytocin nasal spray (Syntocinon) or a placebo nasal s

In a double blind, randomized controlled trial, young people with Autism Spectrum Disorders are randomly assigned to receive an 8-week course of oxytocin nasal spray (Syntocinon) or a placebo nasal spray. Participants or their carers administer the nasal spray twice daily (morning and night). Participants aged between 12 and 15 receive 18 international units at each administration. Participants aged between 16 and 18 receive 24 international units. Participants are assess before the trial commences, 4-weeks into the trial (midpoint), at treatment completion (8-weeks from commencement) and three months following treatment completion. At each assessment point participants complete a range of assessments, including experimental tests and self-report measures. Participants also complete diagnostic assessments pre-intervention and 3 months post trial completion.