None listed
Conditions
Brief summary
Oxytocin is a natural hormone which plays a critical role in social behavior such as bonding, cooperativeness, trust, emotion recognition and face processing. Autism is a developmental disorder characterized by profound impairments in social behavior, communication and presence of repetitive behaviors. This study aims to assess the efficacy of oxytocin treatment in ameliorating social impairments in young children with autism. In particular, we aim to assess whether oxytocin treatment can improve the capacity for social interaction, face processing and reduce the occurrence of repetitive behaviors.
Interventions
Oxytocin nasal spray.
Duration: 5 week treatment. First week, the dose will start at 3 International Units (IU) and increase by 3IU every 2 days. From the 7th day onwards, participants will receive 12IU for the remaining 4 weeks. The nasal spray will be delivered everyday, morning and night, one spray per nostril
This is a crossover study, so after the first course of treatment, participants will have a 4 week washout period and then commence the alternative treatment. The alternative treatment
Oxytocin nasal spray. Duration: 5 week treatment. First week, the dose will start at 3 International Units (IU) and increase by 3IU every 2 days. From the 7th day onwards, participants will receive 12IU for the remaining 4 weeks. The nasal spray will be delivered everyday, morning and night, one spray per nostril This is a crossover study, so after the first course of treatment, participants will have a 4 week washout period and then commence the alternative treatment. The alternative treatment will follow the same dose escalation procedure as the first course of treatment.
Sponsors
University of Sydney
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
3 Years to 8 Years
Healthy volunteers
No
Inclusion criteria
Meet DSM-IV-TR criteria for ASD
Exclusion criteria
Not sensitive to preservatives (in particular E 216, E 218, and chlorobutanol hemihydrate)
Outcome results
None listed