Status:
COMPLETED
The Effects of Oxytocin on Complex Social Cognition in Autism Spectrum Disorders
Lead Sponsor:
Alexander Kolevzon
Conditions:
Autism
ASD
Eligibility:
All Genders
18-45 years
Phase:
PHASE2
Brief 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.
Detailed Description
Participants receive a one-time administration of 24-IU intranasal oxytocin (or placebo) and perform an empathic accuracy task, a novel and ecologically valid measure of complex social cognition, in c...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 18 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 25 2014
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01183221
Start Date
June 18 2010
End Date
April 25 2014
Last Update
April 15 2021
Active Locations (1)
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1
Mount Sinai School of Medicine - Seaver Autism Center for Research and Treatment
New York, New York, United States, 10029