The Effects of Oxytocin on Complex Social Cognition in Autism Spectrum Disorders

Study Overview
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Brief Summary
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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
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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 conjunction with functional magnetic resonance imaging (fMRI). The investigators will investigate the effects of oxytocin (versus placebo) on the behavioral and neural correlates of empathic accuracy.

Official Title
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The Effects of Oxytocin on Complex Social Cognition in Autism Spectrum Disorders

Conditions
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ASD, Autism

Intervention / Treatment
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* Drug: Syntocinon
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Syntocinon then Placebo<br>24IU intranasal oxytocin, minimum of 3 weeks off, then placebo | Drug: Syntocinon<br>* One dose of 24 IU (3 sprays/nostril)<br>* Other names: Intranasal oxytocin;Drug: Placebo<br>* Intranasal Placebo<br>|
| Placebo Comparator: Placebo then Syntocinon<br>Placebo, minimum of 3 weeks off, then 24IU intranasal oxytocin or placebo | Drug: Syntocinon<br>* One dose of 24 IU (3 sprays/nostril)<br>* Other names: Intranasal oxytocin;Drug: Placebo<br>* Intranasal Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 |