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

Autism Spectrum Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05096676
• Other study ID #: 16082021IG
• Status: Completed
• Phase: N/A
• Start date: August 1, 2016
• Est. completion date: October 1, 2019

Study information

• Verified date: October 2021
• Source: Bar-Ilan University, Israel
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: October 1, 2019
• Est. primary completion date: October 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 12 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder
• Oxytocin

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Prof. Ilanit gordon

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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