NCT01788072

INtranasal OXyTocin for the Treatment of Autism Spectrum Disorders

INtranasal OXyTocin for the Treatment of Autism Spectrum Disorders (ASD)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Holland Bloorview Kids Rehabilitation Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Autism Spectrum Disorder

Interventions

Type	Name	Description
DRUG	Intranasal Oxytocin	24 IU taken twice daily (BID), in the morning and at noon/early afternoon
DRUG	Placebo	24 IU taken twice daily (BID), in the morning and at noon/early afternoon

Timeline

• Start date: 2014-06-01
• Primary completion: 2017-08-01
• Completion: 2017-10-01
• First posted: 2013-02-11
• Last updated: 2025-07-16

Locations

2 sites across 1 country: Canada