Intranasal Oxytocin Treatment for Social Deficits in Children With Autism
Condition: Autism
MeSH terms: Autistic Disorder
Intervention: Oxytocin nasal spray; Placebo
Intervention description: 24IU BID (3 x 0.1 mL [4IU] sprays per nostril twice daily for 4-weeks.; 3 x 0.1 mL sprays per nostril twice daily for 4-weeks.
Intervention MeSH terms: Oxytocin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 54.0
Sex: All
Minimum age: 6 Years
Maximum age: 12 Years
Healthy volunteers: No

Summary:

      Autism is a pervasive developmental disorder characterized by core deficits in social
      behavior and communication, and the presence of repetitive or stereotyped behaviors. It is
      one of three recognized disorders in the autism spectrum which affects an estimated 1 in 88
      children in the United States. At present, pharmacotherapies target only associated features
      of autism, with no effective drug treatments for the social impairments. Several lines of
      evidence now suggest that the neuropeptide oxytocin (OT) may be an effective treatment for
      the core social deficits in autism. Here we will test the effects of twice daily intranasal
      OT (24 IU) over a 4-week period for enhancing social deficits in male and female children
      aged 6-12 years with autism. This research has high potential to lead to the development of
      more effective treatments and earlier interventions for children with autism.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Medically healthy outpatients between 6 and 12 years of age (cut off 12 years and 11
             months)

          -  Intelligence Quotient > 40

          -  Diagnosis of autism spectrum disorder based on the Autism Diagnostic Interview -
             Revised, Autism Diagnostic Observation Schedule, and DSM-IV criteria

          -  Clinical Global Impression severity rating of 4 or higher

          -  Care provider who can reliably bring subject to clinic visits, provide trustworthy
             ratings, and interacts with the subject on a regular basis

          -  Stable medications for at least 4 weeks

          -  No planned changes in psychosocial interventions during the trial

          -  Willingness to provide blood samples.

        Exclusion Criteria:

          -  Diagnostics and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) diagnosis
             of schizophrenia, schizoaffective disorder, or psychotic disorder

          -  Regular nasal obstruction or nosebleeds

          -  Active medical problems: unstable seizures, significant physical illness (e.g.,
             serious liver, renal, or cardiac pathology)

          -  Sensitivity to preservatives (in particular E 216, E 218, and chlorobutanol
             hemihydrate)

          -  A genetic abnormality (e.g., Fragile X Syndrome)

          -  Significant hearing or vision impairments

          -  Habitually drinks large volumes of water

          -  Pregnancy, breastfeeding, or child birth within the last 6 months

          -  Sexually active females not using a reliable method of contraception.