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

• Status: Completed
• Trial end date: 2014-04-25
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alexander Kolevzon; Bartz, Jennifer, Ph.D.
• Treatments: Oxytocin

Criteria

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