Intranasal Oxytocin for the Treatment of Children and Adolescents With Autism
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 60
- Locations
- 2
- Primary Endpoint
- Efficacy of Intranasal Oxytocin vs. Placebo on Measures of Social Function
Study Overview
Brief 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.
Detailed Description
Extensive data has been accumulated to suggest that central release of oxytocin is important for social cognition and function, as well as likely involved in anxiety modulation and repetitive behaviors. The Principal Investigator and Co-Principal Investigator of this study have previously documented: 1) an association between ASD and a single nuclear polymorphism of the oxytocin receptor gene, 2) ability to measure oxytocin levels in the blood by enzyme immunoassay and 3) preliminary data to support safety and efficacy of intranasal oxytocin in the treatment of social deficits and repetitive behaviors in adults with autism. A medication treatment targeting the core deficits of ASD in childhood is highly valuable because it could influence the developmental trajectory and make further psychosocial interventions possible. In this context, we propose a randomized placebo controlled trial of intranasal oxytocin in children and adolescents with ASD.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 10 Years to 17 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Intranasal Oxytocin (Syntocinon)
The proposed dosing schedule is 0.4 IU/kg, taken twice daily, for a maximum of 24 IUs per dose
Intervention: Intranasal Oxytocin (Drug)
Placebo
The proposed dosing schedule is 0.4 IU/kg, taken twice daily, for a maximum of 24 IUs per dose
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Efficacy of Intranasal Oxytocin vs. Placebo on Measures of Social Function
Time Frame: 12 and 24 weeks
This will be measured by a change in score on the Aberrant Behavior Checklist (ABC) - Social Withdrawal Subscale (0-48, where lower scores indicate improvement)
Secondary Outcomes
- Number of Participant Considered Social Responders(12 Weeks)
- Number of Participant Considered Overall Responders(12 Weeks)
- Safety and Tolerability of Intranasal Oxytocin in Children and Adolescents With ASD(12 Weeks)
- Efficacy of Intranasal Oxytocin vs. Placebo on Measures of Social Cognition(12 Weeks)
- Efficacy of Intranasal Oxytocin vs. Placebo on Measures of Social Function(12 Weeks)
- Efficacy of Intranasal Oxytocin vs. Placebo on Measures of Anxiety(12 Weeks)
- Efficacy of Intranasal Oxytocin vs. Placebo on Measures of Repetitive Behaviors(12 Weeks)
- Efficacy of Intranasal Oxytocin vs. Placebo on Measures of Quality of Life(12 Weeks)