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

Phase 2

Completed

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 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.

Recruitment & 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

Arm && Interventions

Group	Intervention	Description
Placebo then Syntocinon	Placebo	Placebo, minimum of 3 weeks off, then 24IU intranasal oxytocin or placebo
Syntocinon then Placebo	Placebo	24IU intranasal oxytocin, minimum of 3 weeks off, then placebo
Syntocinon then Placebo	Syntocinon	24IU intranasal oxytocin, minimum of 3 weeks off, then placebo
Placebo then Syntocinon	Syntocinon	Placebo, minimum of 3 weeks off, then 24IU intranasal oxytocin or placebo

Primary Outcome Measures

Name	Time	Method
Fmri BOLD Response During Empathic Accuracy Task	45 minutes after oxytocin/placebo administration	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.
Empathic Accuracy Performance	45 minutes after drug/placebo administration	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.

Secondary Outcome Measures