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Trial · Interventional

CompletedNot applicableRegistry data

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

NCTNCT05096676 (opens ClinicalTrials.gov in a new tab)Other id16082021IG
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Not applicable
Enrollment
58 participants (actual)
Sponsor
Prof. Ilanit gordon · Other
Design
Randomized · Triple masking
Countries
Not stated
Start
1 Aug 2016
Primary completion
1 Oct 2019
Completion
1 Oct 2019
First posted
27 Oct 2021
Last update posted
27 Oct 2021
Conditions
Autism Spectrum Disorder · Oxytocin

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20162017201820192020
  1. N/A

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

    NCT05096676

    1 Aug 2016 to 1 Oct 2019

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Oxytocin: Including placeboDrug

Arms2

  • Experimental

    Adolescents diagnosed with Autism spectrum disorder

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

  • 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.

Primary outcomes1

Outcomes the sponsor listed as primary.

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

    Time frame · During each session

    Registry description

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

Secondary outcomes(2)

  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

    Registry description

    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

    Registry description

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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies2

Studies that cite this trial.

Studies with results

2 studies on this page

Indexing hint: Randomized controlled trial · 2022

2 results

Oxytocin impacts top-down and bottom-up social perception in adolescents with ASD: a MEG study of neural connectivity.

Korisky et al. 2022Molecular autismcited by 14

PMID 36064612PMC9446859DOI 10.1186/s13229-022-00513-6PUB-36064612

CC BY2 results
Download PDFSee results (2)

Indexing hint: Randomized controlled trial · 2022

2 results

The dual neural effects of oxytocin in autistic youth: results from a randomized trial.

Korisky et al. 2022Scientific reportscited by 3

PMID 36175473PMC9523043DOI 10.1038/s41598-022-19524-7PUB-36175473

CC BY2 results
Download PDFSee results (2)

Eligibility

Who could join, as posted.

Sex
Male
Age
from 12 Years up to 18 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
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

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