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

Plain-language guide to NCT05096676: not phased randomized trial of Oxytocin, 58 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT05096676
Phase
not phased
Status
completed
Start
2016-08-01
Completion (planned or actual)
2019-10-01
Participants
58 (actual)
Design
randomized, triple-blind, basic_science
Conditions studied
Autism Spectrum Disorder; Oxytocin
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

In this not phased trial, researchers set out to test Oxytocin.

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.

It had two arms (groups): Adolescents diagnosed with Autism spectrum disorder (experimental) and Typically developing adolescents (no intervention).

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.

The registry classes the interventions as drug.

More on the Plan

In the current study, the investigators aimed to explore oxytocin's influences on neural components that relate to social processing.

Namely, the researchers 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.

Who Took Part

58 actual participants took part.

It was open to men only aged from 12 years up to 18 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: 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).

The full record lists 4 inclusion and 11 exclusion criteria; among the exclusions: chronic medical problems; cardiovascular risk factors; CNS disease.

How the Study Was Run

The set-up was randomized, crossover and triple-blind.

Random assignment meant chance, not the researchers, decided who got Oxytocin and who got the comparison, which limits bias.

Each person switched between Oxytocin and the comparison at some point, usually with a gap in between.

As a double-blind Oxytocin study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider and investigator.

It started in 2016-08-01 with completion listed for 2019-10-01.

Its stated primary purpose is basic science.

What Was Measured

Researchers chose this as the main measure: The change in social-related neural components (time-locked neural activity) with and without oxytocin (time frame: During each session).

It also tracked 2 secondary outcomes, for example The change in oscillatory activity - power magnitude of Delta, Theta, Alpha, Beta and Gamma neural bands with and without oxytocin.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Oxytocin in 58 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Oxytocin compound page, all human trials.

Our Notes on the Compound

Oxytocin: A peptide hormone with established obstetric medical uses and a less settled role in research on behavior, sexual function and appetite.

Related Pages

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.