Clinical trial NCT01183221: The Effects of Oxytocin on Complex Social Cognition in Autism Spectrum Disorders
Official title: The Effects of Oxytocin on Complex Social Cognition in Autism Spectrum Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Autism
ASD
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2010-08-17
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: BASIC_SCIENCE

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.

Eligibility 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

Primary outcomes:
measure: Empathic Accuracy Performance
timeFrame: 45 minutes after drug/placebo administration
measure: Fmri BOLD Response During Empathic Accuracy Task
timeFrame: 45 minutes after oxytocin/placebo administration
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Mount Sinai School of Medicine - Seaver Autism Center for Research and Treatment
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Jennifer Bartz, P.h.D.
role: PRINCIPAL_INVESTIGATOR
References: