Understanding Oxytocin's Neural and Behavioral Effects in Adolescents Diagnosed With Autism
NCT ID: NCT05096676
Last Updated: 2021-10-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
58 participants
INTERVENTIONAL
2016-08-01
2019-10-01
Brief Summary
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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
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
TRIPLE
Study Groups
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Adolescents diagnosed with Autism spectrum disorder
Participants in the ASD group received oxytocin and placebo in a randomized, double-blind placebo-controlled manner.
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.
Typically developing adolescents
Control participants were recruited using online ads. This group did not receive oxytocin or placebo due to ethical constraints in Israel.
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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 Years
18 Years
MALE
Yes
Sponsors
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Prof. Ilanit gordon
OTHER
Responsible Party
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Prof. Ilanit gordon
Principal Investigator
References
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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.
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.
Provided Documents
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Document Type: Statistical Analysis Plan
Other Identifiers
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16082021IG
Identifier Type: -
Identifier Source: org_study_id