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