A Course of Oxytocin to Improve Social Communication in Young Children with Autism

Phase 4

Recruiting

• Conditions: Autism Spectrum Disorder; Mental Health - Autistic spectrum disorders

• Registration Number: ACTRN12617000441314
• Lead Sponsor: niversity of Sydney

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-03-27
• Last Update Posted: 15 July 2019

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 160

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified