None listed
Conditions
Brief 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.
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 cont
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.
Sponsors
University of Sydney
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
3 Years to 12 Years
Healthy volunteers
No
Inclusion criteria
Participants must meet DSM-5 criteria for Autism Spectrum Disorder (ASD)..
Exclusion criteria
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): 1. severely compromised cardiac function 2. severely compromised hepatic function 3. 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.
Outcome results
None listed