Understanding Oxytocin's Neural and Behavioral Effects in Adolescents Diagnosed With Autism

The investigators explored the neural and behavioral effect of oxytocin on youth with Autism spectrum disorder using magnetoencephalography (MEG). The investigators hypothesize that oxytocin will modulate neural activity to resemble patterns observed in the age-matched control group.

Thirty-two adolescents with autism and 26 typically developing adolescents participated in this randomized, double-blind MEG study. Individuals with autism arrived at the lab twice and received an acute dose of intranasal oxytocin or placebo in each session. During the scans, participants were asked to complete several tasks related to social perception - such as identification of social and non-social stimuli.

Study Overview

• Status: Completed
• Conditions: Autism Spectrum Disorder; Oxytocin
• Intervention / Treatment: Drug: Oxytocin: Including placebo

Detailed Description

In the current study, the investigators aimed to explore oxytocin's influences on neural components that relate to social processing. Namely, we focused on M100, M170, and M250, which tend to show atypical patterns in individuals with autism.

The investigators also examined the effects of oxytocin on time dynamics - the change in specific oscillation over time and its effects on neural connectivity patterns.

• Study Type: Interventional
• Enrollment (Actual): 58
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Males, aged 12-18 years
• Native Hebrew speakers
• Normal or corrected-to-normal vision
• Participants in the ASD group had to meet the criteria for ASD in the diagnostic and statistical manual of mental disorders (DSM-5)

Exclusion Criteria:

• Chronic medical problems
• Cardiovascular risk factors
• CNS disease
• Other mental illnesses
• Use of prohibited medications
• Mental retardation
• Impaired vision
• Impaired hearing
• History of significant head injury or neurological illness
• Current substance dependence diagnosis
• Metallic implants, braces or devices in the body

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Adolescents diagnosed with Autism spectrum disorder; Participants in the ASD group received oxytocin and placebo in a randomized, double-blind placebo-controlled manner.	Drug: Oxytocin: Including placebo; Individual received age-dependent dosing of oxytocin and placebo. Participants aged 13-18 years received a dose of 24 IU (3 puffs to each nostril), and younger participants (aged 12 years) received 16 IU.
No Intervention: Typically developing adolescents; Control participants were recruited using online ads. This group did not receive oxytocin or placebo due to ethical constraints in Israel.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The change in social-related neural components (time-locked neural activity) with and without oxytocin	The amplitude (tesla) of three social related neural components will be measured using MEG device	During each session

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The change in oscillatory activity - power magnitude of Delta, Theta, Alpha, Beta and Gamma neural bands with and without oxytocin	The overall power of neural oscillatory activity will be measured using MEG device	During each session
The change in behavioral measurments - reaction times and accurecy rates, with and without oxytocin	Reaction times will be measured in milliseconds and accurecy rates will be defined as the percentage of correct responses	During each session

Collaborators and Investigators

• Sponsor: Prof. Ilanit gordon

Publications and helpful links

General Publications

• Korisky A, Goldstein A, Gordon I. The dual neural effects of oxytocin in autistic youth: results from a randomized trial. Sci Rep. 2022 Sep 29;12(1):16304. doi: 10.1038/s41598-022-19524-7.
• Korisky A, Gordon I, Goldstein A. Oxytocin impacts top-down and bottom-up social perception in adolescents with ASD: a MEG study of neural connectivity. Mol Autism. 2022 Sep 5;13(1):36. doi: 10.1186/s13229-022-00513-6.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2016
• Primary Completion (Actual): October 1, 2019
• Study Completion (Actual): October 1, 2019

Study Registration Dates

• First Submitted: August 16, 2021
• First Submitted That Met QC Criteria: October 24, 2021
• First Posted (Actual): October 27, 2021

Study Record Updates

• Last Update Posted (Actual): October 27, 2021
• Last Update Submitted That Met QC Criteria: October 24, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Autism; MEG; Social perception
• 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: 16082021IG

Drug and device information, study documents

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