INtranasal OXyTocin for the Treatment of Autism Spectrum Disorders

Phase 2

Completed

• Conditions: Autism Spectrum Disorder
• Interventions: Drug: Intranasal Oxytocin; Drug: Placebo

• Registration Number: NCT01788072
• Lead Sponsor: Holland Bloorview Kids Rehabilitation Hospital

Brief Summary

There is substantial evidence from animal model and healthy control data, that oxytocin is involved in the modulation of social cognition. In addition, recent genetics and plasma level studies suggest a possible role for oxytocin in the pathophysiology of Autism Spectrum Disorders (ASD). As a large number of children with ASD are transitioning into adulthood and will likely require treatment, the lack of data to make meaningful treatment recommendations to facilitate adult living is an urgent issue. This study will examine the effect of intranasal oxytocin (IN-OXT) on social function in adults with ASD. It is hypothesized that IN-OXT will be superior to placebo in improving social function by the end of study treatment.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-02-07
• Study First Submitted QC: 2013-02-07
• Study First Posted: 2013-02-11
• Study Start: 2014-06-01
• Primary Completion: 2017-08
• Study Completion: 2017-10-01
• Status Verified: 2018-01
• Last Update Submitted: 2025-07-14
• Last Update Posted: 2025-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intranasal Oxytocin	Intranasal Oxytocin	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Efficacy of intranasal oxytocin vs. placebo on social function in adults with ASD	12 weeks	This will be measured by the Clinical Global Impressions - Improvement Scale - Social (CGI-I-Social).

Secondary Outcome Measures

Name	Time	Method
Efficacy of intranasal oxytocin vs. placebo on a continuous measure of social cognition in adults with ASD	12 weeks	This will be measured by the Revised Eyes Test
Efficacy of intranasal oxytocin vs. placebo on a continuous measure of social function in adults with ASD	12 weeks	This will be measured by the Vineland Adaptive Behavior Scale (VABS-II)
Efficacy of intranasal oxytocin vs. placebo on a continuous measure of social responsiveness in adults with ASD	12 weeks	This will be measured by the Aberrant Behavior Checklist (ABC)
Safety and tolerability of intranasal oxytocin in adults with ASD	12 weeks	This will be measured by the Clinical Global Impressions - Improvement Scale - Global (CGI-I-Global)
Efficacy of intranasal oxytocin vs. placebo on quality of life	12 weeks	This will be measured by the World Health Organization Quality of Life Survey (WHOQOL-BREF)
Efficacy of intranasal oxytocin vs. placebo on anxiety	12 weeks	This will be measured by the Symptom Checklist 90-Revised (SCL-90-R)

Trial Locations

Locations (2)

St. Joseph's Healthcare Hamilton; 🇨🇦 Hamilton, Ontario, Canada

Holland Bloorview Kids Rehabilitation Hospital; 🇨🇦 Toronto, Ontario, Canada