CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 60 enrolled
Drug / intervention
Intranasal Oxytocin +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01908205
NCT01908205Phase 2Completed

Intranasal Oxytocin for the Treatment of Children and Adolescents With Autism

Holland Bloorview Kids Rehabilitation Hospital·interventional·Posted Jul 25, 2013·Updated Jul 16, 2025

In Brief

A Phase 2 clinical trial evaluating Intranasal Oxytocin and Placebo for Autism Spectrum Disorder. Completed, enrolled 60 participants across 2 sites in 2 countries.

Detailed Summary

We are studying an investigational drug called intranasal oxytocin (Syntocinon®). Syntocinon® has been approved by the U.S. Food and Drug Administration for use in helping women breastfeed, but it has not been approved for use in children with ASD. However, there is previous research conducted that has indicated that after administration of oxytocin, adults with ASD demonstrated improvements in social cognition, and reduced repetitive behaviours and anxiety. There is also early research to suggest that children may also benefit in these areas. The purpose of this study is to test if oxytocin works to help children and adolescents with ASD.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada, United States

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJul 25, 2013
Enrollment StartSep 1, 2013
Primary CompletionSep 1, 2015
Study CompletionMar 1, 2016
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 12.9 years ago

Interventions

Intranasal Oxytocindrug

Placebodrug