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OpenTrials
Completed

NCT Number: NCT05096676

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.

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Key information

Conditions

Autism Spectrum Disorder Autistic Disorder Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders Oxytocin

Age range

12 year–18 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. The change in social-related neural components (time-locked neural activity) with and without oxytocin

    Time frame: During each session

    The amplitude (tesla) of three social related neural components will be measured using MEG device

Secondary outcomes

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

    Time frame: During each session

    The overall power of neural oscillatory activity will be measured using MEG device

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

    Time frame: During each session

    Reaction times will be measured in milliseconds and accurecy rates will be defined as the percentage of correct responses

Sponsors and collaborators

Lead sponsor

Prof. Ilanit gordon

Other

Registry information

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Oct 27, 2021
Registry last updated
Oct 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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