A Study of Oxytocin in Children and Adolescents With Autistic Disorder
Condition: Autism
MeSH terms: Autistic Disorder
Intervention: Oxytocin; Placebo
Intervention description: Subjects will use the Syntocinon® Nasal Spray (oxytocin) twice daily for 8 weeks if they are randomized to that arm in the Randomized Phase. All subjects will use the Syntocinon® Nasal Spray twice daily for 8 weeks in the Open Label Phase.
Subjects ages 3-10 years old will be titrated up to a maximum dose of 24 International units (IU). Subjects ages 11-17 years old will be titrated up to a maximum dose of 32IU.; Placebo Nasal Spray
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: 25.0
Sex: All
Minimum age: 3 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      The investigators propose to conduct this pilot study to evaluate oxytocin as a supplemental
      treatment for improving social difficulties in individuals with autism.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Between 3 and 17 years old, inclusive.

          -  Have a clinical diagnosis of autistic disorder confirmed according to Diagnostic
             Statistical Manual of Mental Disorders-IV criteria by using the Autism Diagnostic
             Interview - Revised (ADI-R) and/or the Autism Diagnostic Observation Scale (ADOS, Lord
             et al., 1989).

        Exclusion Criteria:

          -  Changes in allied health therapies, behavioral or educational interventions within the
             past 2 months of the baseline visit other than those associated with school holidays.

          -  Changes in psychotropic and alternative medication doses in the last 30 days of the
             baseline visit.

          -  Subjects with a medical condition that might interfere with the conduct of the study,
             confound interpretation of the study results, or endanger their own well-being. This
             includes, but is not limited to, Rett Syndrome, impairment of renal function, evidence
             or history of malignancy or any significant hematological, endocrine, cardiovascular
             (including any rhythm disorder and uncontrolled hypertension), respiratory, hepatic,
             or gastrointestinal disease.

          -  Marked sensory impairment such as deafness or blindness that would interfere with
             conduct of the study.

          -  Pregnancy/Nursing because of the unknown effects of oxytocin to unborn babies and/or
             nursing infants. All females of child-bearing potential will be administered a urine
             or serum pregnancy test at screening and at any point during the study at physician
             discretion. Refusal to undergo a pregnancy test will result in exclusion from the
             study. The investigators will share results of pregnancy test with the subject's legal
             guardian.

          -  Refusal to practice contraception if sexually active because the effects of exposure
             to high concentrations of oxytocin on sperm or newly conceived embryos are unknown.
             Sexually active men and women should not take part in this study if they and their
             partners are not both using an effective birth control method (for example, women use
             birth control pills, an intrauterine device (IUD) or a diaphragm and men use condoms).

          -  Inability of caretakers to speak English.

          -  Absence of a consistent caretaker to report on symptoms.

          -  Subjects who, in the Investigator's opinion, might not be suitable for the study.