None listed
Conditions
Brief 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.
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 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 comme
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.
Sponsors
University of Sydney
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
Male
Age
12 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
Male youth with a primary diagnosis of Autism or Asperger disorder with a mental age of 8 or higher.
Exclusion criteria
Females, mental age below 8. Chronological age below 12.
Outcome results
None listed