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

Primary Purpose

Autism Spectrum Disorder, Oxytocin

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Oxytocin: Including placebo
Sponsored by
Prof. Ilanit gordon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Autism Spectrum Disorder focused on measuring Autism, MEG, Social perception

Eligibility Criteria

12 Years - 18 Years (Child, Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Adolescents diagnosed with Autism spectrum disorder

    Typically developing adolescents

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    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
    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

    Full Information

    First Posted
    August 16, 2021
    Last Updated
    October 24, 2021
    Sponsor
    Prof. Ilanit gordon
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05096676
    Brief Title
    Understanding Oxytocin's Neural and Behavioral Effects in Adolescents Diagnosed With Autism
    Official Title
    Understanding Oxytocin's Neural and Behavioral Effects in Adolescents Diagnosed With Autism
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    August 1, 2016 (Actual)
    Primary Completion Date
    October 1, 2019 (Actual)
    Study Completion Date
    October 1, 2019 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Prof. Ilanit gordon

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Autism Spectrum Disorder, Oxytocin
    Keywords
    Autism, MEG, Social perception

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Model Description
    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.
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    58 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Adolescents diagnosed with Autism spectrum disorder
    Arm Type
    Experimental
    Arm Description
    Participants in the ASD group received oxytocin and placebo in a randomized, double-blind placebo-controlled manner.
    Arm Title
    Typically developing adolescents
    Arm Type
    No Intervention
    Arm Description
    Control participants were recruited using online ads. This group did not receive oxytocin or placebo due to ethical constraints in Israel.
    Intervention Type
    Drug
    Intervention Name(s)
    Oxytocin: Including placebo
    Intervention Description
    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 Outcome Measure Information:
    Title
    The change in social-related neural components (time-locked neural activity) with and without oxytocin
    Description
    The amplitude (tesla) of three social related neural components will be measured using MEG device
    Time Frame
    During each session
    Secondary Outcome Measure Information:
    Title
    The change in oscillatory activity - power magnitude of Delta, Theta, Alpha, Beta and Gamma neural bands with and without oxytocin
    Description
    The overall power of neural oscillatory activity will be measured using MEG device
    Time Frame
    During each session
    Title
    The change in behavioral measurments - reaction times and accurecy rates, with and without oxytocin
    Description
    Reaction times will be measured in milliseconds and accurecy rates will be defined as the percentage of correct responses
    Time Frame
    During each session

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    12 Years
    Maximum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    36175473
    Citation
    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.
    Results Reference
    derived
    PubMed Identifier
    36064612
    Citation
    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.
    Results Reference
    derived

    Learn more about this trial

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

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