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

NCT ID: NCT01183221

Last Updated: 2021-04-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-06-18
• Study Completion Date: 2014-04-25

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.

Conditions

Autism; ASD

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Syntocinon then Placebo

24IU intranasal oxytocin, minimum of 3 weeks off, then placebo

Group Type: EXPERIMENTAL

Syntocinon

Intervention Type: DRUG

One dose of 24 IU (3 sprays/nostril)

Placebo

Intervention Type: DRUG

Intranasal Placebo

Placebo then Syntocinon

Placebo, minimum of 3 weeks off, then 24IU intranasal oxytocin or placebo

Group Type: PLACEBO_COMPARATOR

Syntocinon

Intervention Type: DRUG

One dose of 24 IU (3 sprays/nostril)

Placebo

Intervention Type: DRUG

Intranasal Placebo

Interventions

Syntocinon

One dose of 24 IU (3 sprays/nostril)

Intervention Type: DRUG

Placebo

Intranasal Placebo

Intervention Type: DRUG

Other Intervention Names

Intranasal oxytocin

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alexander Kolevzon

OTHER

Sponsor Role: lead

Responsible Party

Alexander Kolevzon

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Jennifer Bartz, P.h.D.

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

Mount Sinai School of Medicine - Seaver Autism Center for Research and Treatment

New York, New York, United States

Countries

United States

Other Identifiers

GCO 09-0857

Identifier Type: -

Identifier Source: org_study_id