A Course of Oxytocin to Improve Social Communication in Young Children with Autism
University of Sydney
160 participants
Apr 20, 2017
Interventional
Conditions
Summary
Children with ASD aged 3 to 12 years will take a placebo spray for 3 weeks, followed by being randomised to a course of twice-daily nasally-administered oxytocin or placebo for 12 weeks in a double-blind, placebo-controlled between-subject design. We hope to identify children with ASD who benefit from this treatment and the associated cognitive and neurobiological markers that predict such changes.
Eligibility
Inclusion Criteria1
- Participants must meet DSM-5 criteria for Autism Spectrum Disorder (ASD)..
Exclusion Criteria5
- Participants will be excluded if they are known to be hypersensitive to the preservatives in the nasal spray (E216, E218, and chlorobutanol hemihydrates). Participants with severe nasal obstruction/blockage will be excluded as this is likely to reduce the efficacy of the nasal spray medication. Further, participants whose caregivers report that they have a serious medical condition from one of the following categories will be excluded (evidenced through medical examination):
- severely compromised cardiac function
- severely compromised hepatic function
- severely compromised renal function
- These categories relate to common side-effects reported in previous oxytocin studies and recommended contraindications from product information for the nasal spray and intravenous formulations of oxytocin that have been marketed previously.
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Interventions
Participants will be randomly allocated to receive either active oxytocin or placebo nasal spray twice daily over a period of 12 weeks. Participants randomly allocated to receive active oxytocin will administer 16 IU of nasal spay twice a day (1 x 8 IU spray per nostril), receiving a total of 32IU per day of oxytocin. Prior to randomisation to either active treatment or placebo, all participants will be requested to administer a placebo spray for 3 weeks in order to establish a baseline to control for expectancy effects. Participants will be unaware (masked) that they are receiving a placebo spray. Study staff will be aware that participants are receiving a placebo spray during this 3-week period. Caregivers will be requested to complete a twice-daily check of treatment adherence, on a compliance and side effects monitoring sheet which will be provided to them at the outset of the study. Treatment compliance will also be assessed by a study staff member during a follow-up phone call to participants' caregivers which is to be placed 6 weeks after the initiation of either active oxytocin or placebo nasal spray administration.
Locations(1)
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ACTRN12617000441314