The Effects of Oxytocin on Complex Social Cognition in Autism Spectrum Disorders
Condition: Autism; ASD
MeSH terms: Autistic Disorder; Autism Spectrum Disorder
Intervention: Syntocinon; Placebo
Intervention description: One dose of 24 IU (3 sprays/nostril); Intranasal Placebo
Intervention MeSH terms: Oxytocin
Phase: Phase 2
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Participants are randomized to receive 24IU intranasal oxytocin or placebo on days separated by a minimum of 3 weeks. Randomization order to drug condition is counter-balanced.
Masking: Double (Participant, Investigator)
Masking description: Both the participant and investigator are blind to drug condition.
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: No

Summary:

      This study examines the effects of a single dose of intranasal oxytocin (vs. placebo) on
      complex social cognition in adults with autism spectrum disorders.
    

Eligibility criteria:

        Inclusion Criteria:

          -  In good physical health

          -  Meet criteria for ASD according to psychiatric interview using the Diagnostic and
             Statistic Manual, Fourth Edition (DSM-IV)

          -  Must be a history of developmental delay

          -  Must meet full criteria for ASD on the Autism Diagnostic Interview- Revised (ADI-R) on
             either the social or communication domains and within two points on other domain (only
             if parent available for interview)

          -  Must meet full criteria for ASD on the Autism Diagnostic Observation Schedule- Generic
             (ADOS-G) on the social domain. Meeting for ASD on the communication domain and total
             domain is not necessary

          -  Must have a verbal IQ greater than 75, as measured by the Wechsler Adult Intelligence
             Scale- Fourth Edition (WAIS- III). Intelligence testing performed at other sites or
             through another protocol at this site within the past year will also be accepted

          -  Capability of performing experimental tasks (i.e. can read and understand task
             instructions, cooperate with procedures)

          -  Informed consent and capacity

          -  Female participants must remain on birth control for the duration of the study

        Exclusion Criteria:

          -  Participants with any primary psychiatric diagnosis at screening

          -  Participants with a medical history of neurological disease, including, but not
             limited to, epilepsy/seizure disorder (except simple febrile seizures), movement
             disorder, tuberous sclerosis, fragile X, and any other known genetic syndromes, or
             known abnormal MRI/structural lesion of the brain

          -  Participants who are pregnant, who gave birth in the last six months, or who are
             currently breastfeeding

          -  Participants 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

          -  Participants with evidence or history of malignancy or any significant hematological
             endocrine, cardiovascular (including rhythm disorder), respiratory, renal, hepatic,
             gastrointestinal disease, or other major medical conditions

          -  Participants taking psychoactive medication(s) (e.g., stimulants, antidepressants,
             antipsychotics, antiepileptics, anxiolytics, clondine)

          -  Participants who, in the Investigator's opinion, might not be suitable for the study

          -  Participants who are involved in another study whose procedures could influence
             performance in the current study

          -  Female participants who do not stay on birth control for the duration of the study

          -  Participants who have a known contraindication to the MRI scan: including sever
             claustrophobia or any kind of metal implant in the body