Autism Clinical Trial
Official title:
The Effects of Oxytocin on Complex Social Cognition in Autism Spectrum Disorders
Verified date | March 2021 |
Source | Icahn School of Medicine at Mount Sinai |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study examines the effects of a single dose of intranasal oxytocin (vs. placebo) on complex social cognition in adults with autism spectrum disorders.
Status | Completed |
Enrollment | 30 |
Est. completion date | April 25, 2014 |
Est. primary completion date | April 25, 2014 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 45 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Mount Sinai School of Medicine - Seaver Autism Center for Research and Treatment | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Alexander Kolevzon |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Empathic Accuracy Performance | Participants watch videos of targets describing positive and negative autobiographical events and provide continuous ratings of how positive-negative the target is feeling on a 9-point Likert scale. Empathic accuracy is operationalized as a timecourse correlation between perceiver inferences about target affect and targets' own affect ratings. | 45 minutes after drug/placebo administration | |
Primary | Fmri BOLD Response During Empathic Accuracy Task | Images will be acquired using a 3.0 Tesla Siemens Allegra MRI scanner equipped to acquire gradient-echo, echoplanar T2*-weighted images (EPI) with blood oxygenation level dependent (BOLD) contrast. Each volume will comprise 26 axial slices of 4.5mm thickness and a 3.5 x 3.5mm in-plane resolution, aligned along the AC-PC axis. Volumes will be acquired continuously every 2 seconds. Each run will begin with 5 'dummy' volumes, which will be discarded from further analyses. At the end of the scanning session, a T-1 weighted structural image will be acquired from each participant. | 45 minutes after oxytocin/placebo administration |
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