Study of Oxytocin in Autism to Improve Reciprocal Social Behaviors
Condition: Autism Spectrum Disorders
MeSH terms: Autistic Disorder; Autism Spectrum Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this research study is to learn about the effects of supplemental intranasal
      oxytocin as a treatment for improving social difficulties in children and adolescents with
      autism. This study will also provide additional information about the safety and tolerability
      of intranasal oxytocin. Investigators expect oxytocin will increase social motivation,
      improving daily living skills and quality of life.
    

Detailed description: 
      There is a tremendous unmet need for accessible treatments that address core symptoms of ASD
      and are safe for sustained use. The Study of Oxytocin in ASD to improve Reciprocal Social
      Behaviors or (SOARS-B) will test a very promising potential treatment-intranasal oxytocin-for
      ASD's fundamental social communication deficits in a large, group of verbal and nonverbal
      children. SOARS-B will also provide information about the regulation of DNA methylation and
      transcription of the oxytocin receptor gene (OXTR), as well as other genes relevant to
      oxytocin's CNS activity, as a function of time and in response to oxytocin treatment. These
      data will fill a key gap in our understanding of oxytocin's role in ASD and its ability to
      alter epigenetic modifications of the OXTR.
    

Intervention name(s): Double blind phase Placebo Nasal Spray; double Blind Oxytocin Nasal Spray; Open Label intranasal oxytocin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): This nasal spray will contain all of the ingredients that are in the active oxytocin spray in the same quantities, except oxytocin will NOT be added to the solution. It will be packaged using the same container system as the active oxytocin nasal spray. Each bottle's label will have its own unique nonsequential randomly assigned number and not a lot number to facilitate masking. Dose titration will occur using exactly the same criteria and procedures as for active study drug.; Each insufflation will deliver 8 IU or 24 IU of oxytocin. A maximum of 3 insufflations at a time will be required. Dosing will be flexible between 8 IU/day and 80 IU/day, typically in two divided doses delivered in the morning and in the afternoon. Doses will typically increase by 8 IU twice daily (BID) at week 2 and weeks 4 and 8 until achieving the target dose of 24 IU BID at week 8. Subsequently doses may be increased in 8 IU BID increments ONLY at each visit until a maximum dose of 40 IU BID is achieved.Each bottle's label will have its own unique nonsequential randomly assigned number and not a lot number to facilitate masking. During the open label phase after approximately March 2019 the study used only the 24 IU /0.10 ml formulation and the maximum dose was 72 IU per day.; All participants who completed the 24 week double blind phase were eligible to join a 24 week open label phase in which all participants received intranasal oxytocin
Other intervention name(s): DB Placebo (PL); DB Intranasal Oxytocin (OT); open label treatment
Intervention MeSH terms: Oxytocin
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, Double-blind, placebo-controlled clinical trial for 24 weeks. Followed by 24 week open label treatment period in which ALL participants receive Oxytocin
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: autism, ASD, autistic, Asperger's, PDD-NOS, oxytocin