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Study on the Effects of Intranasal Oxytocin on Learning in Youth with Autism Spectrum Disorder

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a treatment for Autism Spectrum Disorder (ASD). The treatment being tested is a nasal spray containing oxytocin, a synthetic form of a naturally occurring hormone. The study will compare the effects of oxytocin to a placebo. The main goal is to understand how oxytocin affects brain function and learning in young people with ASD.

Participants in the study will receive a single dose of oxytocin through a nasal spray. The study will be conducted in a way that neither the participants nor the researchers know who receives the oxytocin or the placebo, ensuring unbiased results. The study will take place over three different periods, allowing researchers to observe any changes in brain activity and learning abilities after the administration of oxytocin.

The study will also look at other factors, such as heart rate variability, which is a measure of how the heart responds to different situations. This will help researchers understand if oxytocin has any additional effects on the body. The study aims to provide insights into whether oxytocin can improve learning and brain function in individuals with ASD.

The research process

The trial runs in 8 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Participation begins after meeting the criteria: age between 12 and 21, ability to communicate with the study team, and a confirmed diagnosis of autism spectrum disorder.
Step 2
Initial assessment
An initial assessment is conducted to establish baseline measurements. This may include evaluations of neural plasticity and cognitive flexibility.
Step 3
First treatment period
Receive a single dose of oxytocin or placebo via nasal spray. The dose could be either 8 IU or 24 IU.
Neural plasticity is evaluated using EEG 40 minutes after administration. Cognitive flexibility is assessed through a computerized task.
Step 4
Washout period
A washout period follows the first treatment to ensure no carryover effects before the next treatment period begins.
Step 5
Second treatment period
Receive another single dose of oxytocin or placebo via nasal spray. The dose could be either 8 IU or 24 IU, different from the first period.
Neural plasticity and cognitive flexibility are evaluated again using the same methods as in the first period.
Step 6
Second washout period
Another washout period occurs to clear any effects from the second treatment before the final treatment period.
Step 7
Third treatment period
Receive the final single dose of oxytocin or placebo via nasal spray. The dose could be either 8 IU or 24 IU, different from the previous periods.
Final evaluations of neural plasticity and cognitive flexibility are conducted.
Step 8
Final assessment
A comprehensive assessment is performed to compare results across all treatment periods. This includes measuring heart rate variability and evaluating symptom severity.

Who can join the trial?

3 criteria

Participants must be between the ages of 12 and 21, including both ages.
Participants and their caregivers, if they have them, must be able to talk with the study team, understand what the study involves, and follow the study's requirements.
Participants must have a confirmed diagnosis of autism spectrum disorder (ASD), which is a condition that affects how a person communicates and interacts with others.

Who cannot join the trial?

4 criteria

Individuals who do not have a diagnosis of Autism Spectrum Disorder (ASD) cannot participate. ASD is a condition that affects how a person communicates and interacts with others.
Participants must be within the specified age range for the study. If you are outside this age range, you cannot participate.
Both males and females are eligible, so gender is not a reason for exclusion.
Participants must not belong to a group that is considered vulnerable, which means they need extra protection in research settings.

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Verified sites

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Verified
Oslo Universitetssykehus HF
Oslo, Norway

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Investigated drugs

Oxytocin is a medication being studied for its potential effects on brain function and learning in young people with autism spectrum disorders. In this trial, oxytocin is administered through the nose. Researchers are interested in seeing if oxytocin can help improve the brain's ability to change and adapt, which is known as neural plasticity, and enhance learning abilities in participants.

What is already known about the treatment

Oxytocin – Oxytocin is administered intranasally, meaning it is delivered through the nose using a spray. It is currently being studied in clinical trials for its potential effects on neural plasticity and learning in individuals with autism spectrum disorder (ASD). The main therapeutic indication being explored is its ability to enhance social and cognitive functions in people with ASD. At the molecular level, oxytocin works by binding to oxytocin receptors in the brain, which can influence social behavior and emotional responses. It is classified pharmacologically as a neuropeptide hormone.

Investigated diseases

Autism Spectrum Disorder – Autism Spectrum Disorder (ASD) is a developmental condition that affects communication, behavior, and social interaction. Individuals with ASD may have difficulty understanding social cues, forming relationships, and may engage in repetitive behaviors or have specific interests. The severity and symptoms can vary widely among individuals, with some experiencing mild challenges and others facing significant difficulties in daily functioning. ASD is typically identified in early childhood, although signs can sometimes be noticed earlier. The condition is lifelong, but symptoms can change over time, and individuals may develop new skills and coping strategies.