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

Sponsor

Prof. Ilanit gordon (Other)

Overall Status

Completed

CT.gov ID

NCT05096676

Collaborator

(none)

Enrollment

Arms

Actual Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Autism Spectrum Disorder Oxytocin	Drug: Oxytocin: Including placebo	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

58 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention 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.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:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Basic Science

Official Title:

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

Actual Study Start Date :

Aug 1, 2016

Actual Primary Completion Date :

Oct 1, 2019

Actual Study Completion Date :

Oct 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Adolescents diagnosed with Autism spectrum disorder Participants in the ASD group received oxytocin and placebo in a randomized, double-blind placebo-controlled manner.	Drug: 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.
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.

Arm

Intervention/Treatment

Experimental: Adolescents diagnosed with Autism spectrum disorder

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

Drug: 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.

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.

Outcome Measures

Primary Outcome Measures

The change in social-related neural components (time-locked neural activity) with and without oxytocin [During each session]
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 [During each session]
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 [During each session]
Reaction times will be measured in milliseconds and accurecy rates will be defined as the percentage of correct responses

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years to 18 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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)