INtranasal OXyTocin for the Treatment of Autism Spectrum Disorders (ASD)
Overview
- Phase
- Phase 2
- Intervention
- Intranasal Oxytocin
- Conditions
- Autism Spectrum Disorder
- Sponsor
- Holland Bloorview Kids Rehabilitation Hospital
- Enrollment
- 70
- Locations
- 2
- Primary Endpoint
- Efficacy of intranasal oxytocin vs. placebo on social function in adults with ASD
- Status
- Completed
- Last Updated
- 9 months ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Intranasal Oxytocin
Intervention: Intranasal Oxytocin
Placebo
Intervention: Placebo
Outcomes
Primary Outcomes
Efficacy of intranasal oxytocin vs. placebo on social function in adults with ASD
Time Frame: 12 weeks
This will be measured by the Clinical Global Impressions - Improvement Scale - Social (CGI-I-Social).
Secondary Outcomes
- Efficacy of intranasal oxytocin vs. placebo on a continuous measure of social cognition in adults with ASD(12 weeks)
- Efficacy of intranasal oxytocin vs. placebo on a continuous measure of social function in adults with ASD(12 weeks)
- Efficacy of intranasal oxytocin vs. placebo on a continuous measure of social responsiveness in adults with ASD(12 weeks)
- Safety and tolerability of intranasal oxytocin in adults with ASD(12 weeks)
- Efficacy of intranasal oxytocin vs. placebo on quality of life(12 weeks)
- Efficacy of intranasal oxytocin vs. placebo on anxiety(12 weeks)