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

This study examines the effects of a single dose of intranasal oxytocin (vs. placebo) on complex social cognition in adults with autism spectrum disorders.

Study Overview

• Status: Completed
• Conditions: Autism; ASD
• Intervention / Treatment: Drug: Placebo; Drug: Syntocinon

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10029
      • Mount Sinai School of Medicine - Seaver Autism Center for Research and Treatment

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 43 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Alexander Kolevzon
• Investigators: Principal Investigator: Jennifer Bartz, P.h.D., Icahn School of Medicine at Mount Sinai

Study record dates

Study Major Dates

• Study Start (Actual): June 18, 2010
• Primary Completion (Actual): April 25, 2014
• Study Completion (Actual): April 25, 2014

Study Registration Dates

• First Submitted: August 12, 2010
• First Submitted That Met QC Criteria: August 13, 2010
• First Posted (Estimate): August 17, 2010

Study Record Updates

• Last Update Posted (Actual): April 15, 2021
• Last Update Submitted That Met QC Criteria: March 22, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Autistic Disorder; Autism Spectrum Disorder; Physiological Effects of Drugs; Reproductive Control Agents; Oxytocics; Oxytocin
• Other Study ID Numbers: GCO 09-0857

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No