Study of Oxytocin in Autism to Improve Reciprocal Social Behaviors
Condition: Autism Spectrum Disorders
MeSH terms: Autistic Disorder; Autism Spectrum Disorder
Intervention: Double blind phase Placebo Nasal Spray; double Blind Oxytocin Nasal Spray; Open Label intranasal oxytocin
Intervention description: 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
Intervention MeSH terms: Oxytocin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
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)
Masking description: Quadruple
Enrollment: 290.0
Sex: All
Minimum age: 3 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: autism, ASD, autistic, Asperger's, PDD-NOS, oxytocin

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Be between the ages of 3 years 0 months and 17 years 11 months at the time of
             randomization

          -  Be diagnosed by clinician experienced in assessment of ASD with autistic disorder,
             Asperger's syndrome, or PDD-NOS using DSM-V-TR criteria

          -  Must have clinical diagnosis of ASD confirmed using the Autism Diagnostic Observation
             Scale (ADOS, Lord et al., 2001)

          -  Must have clinical diagnosis of ASD confirmed using the Autism Diagnostic
             Interview-Revised (ADI-R, Rutter, 2003). ASD criteria proposed by Risi (2006).
             Specifically, subject must be within 1 point of autism criteria on both social and
             communication domains of the ADI or meet autism criteria in one of these ADI domains
             and come within 2 points of autism criteria in the other

          -  Have a guardian who is able to provide informed consent

          -  If cognitively able, subject must be able to provide informed assent/consent

        Exclusion Criteria:

          -  Have a known diagnosis of Rett Syndrome or Childhood Disintegrative Disorder, or have
             marked sensory impairment such as deafness or blindness

          -  Have active cardiovascular disease or renal disease that is not controlled by
             medication

          -  Subjects who are pregnant, lactating, or who refuse to practice contraception if
             sexually active

          -  Subjects who have had changes in allied health therapies, behavioral or educational
             interventions within the two months prior to randomization other than those associated
             with school holidays

          -  Subjects who have had changes in psychiatric medications within 4 weeks of
             randomization

          -  Subjects who have had previous chronic treatment with oxytocin

          -  Subjects who have caretakers who are unable to speak English, be consistently present
             at visits to report on symptoms, or are otherwise judged as unable to comply with the
             protocol by the data collection site team

          -  Subjects with active seizures within the 6 months preceding screening or baseline
             -added part way through study in response to subject death.