The Effects of Oxytocin on Complex Social Cognition in Autism Spectrum Disorders (NCT01183221) | Clinical Trial Compass
CompletedPhase 2
The Effects of Oxytocin on Complex Social Cognition in Autism Spectrum Disorders
United States30 participantsStarted 2010-06-18
Plain-language 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.
Who can participate
Age range18 Years – 45 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
* …
What they're measuring
1
Empathic Accuracy Performance
Timeframe: 45 minutes after drug/placebo administration
2
Fmri BOLD Response During Empathic Accuracy Task
Timeframe: 45 minutes after oxytocin/placebo administration