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

NCT05096676 | Completed

• 1 other identifier: 16082021IG
• Study Type: interventional
• Target: 58
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Autism Spectrum Disorder; Oxytocin

Keywords

Autism; MEG; Social perception

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• The change in oscillatory activity - power magnitude of Delta, Theta, Alpha, Beta and Gamma neural bands with and without oxytocin

  During each session

• The change in behavioral measurments - reaction times and accurecy rates, with and without oxytocin

  During each session

Study Arms (2)

Adolescents diagnosed with Autism spectrum disorder

EXPERIMENTAL

Participants in the ASD group received oxytocin and placebo in a randomized, double-blind placebo-controlled manner.

Drug: Oxytocin: Including placebo

Typically developing adolescents

NO INTERVENTION

Control participants were recruited using online ads. This group did not receive oxytocin or placebo due to ethical constraints in Israel.

Interventions

Oxytocin: Including placebo DRUG

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.

Adolescents diagnosed with Autism spectrum disorder

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Prof. Ilanit gordon: lead

Related Publications (2)

• 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.

  PMID: 36175473 DERIVED

• 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.

  PMID: 36064612 DERIVED

MeSH Terms

Conditions

Autism Spectrum Disorder; Autistic Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Youth with autism participated in a randomized, double-blind placebo-controlled trial. Participants visited the lab for two sessions. In one of the sessions, they received oxytocin, and in the other, they received the placebo. Intranasal doses of 40 international units of oxytocin (IU)/mL were prepared by the "Maayan-Haim" pharmacy, Israel. We used age-dependent dosing such that 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. Typically-developing youth underwent the same experimental procedure but did not receive oxytocin or placebo due to ethical constraints in Israel.

Study Record Dates

• First Submitted: August 16, 2021
• First Posted: October 27, 2021
• Study Start: August 1, 2016
• Primary Completion: October 1, 2019
• Study Completion: October 1, 2019
• Last Updated: October 27, 2021

Record last verified: 2021-10