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Study on the Effects of Intranasal Oxytocin on Social and Repetitive Behaviors in Youth with Autism Spectrum Disorder

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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 medication called oxytocin on young people with autism spectrum disorder (ASD). Autism spectrum disorder is a developmental condition that affects how a person communicates and interacts with others. The study will use a nasal spray form of oxytocin, which is a synthetic version of a hormone that naturally occurs in the body and is known to play a role in social bonding and behavior.

The purpose of the study is to evaluate how oxytocin affects social and repetitive behaviors in individuals with autism. Participants in the study will receive doses of oxytocin through a nasal spray twice a day for four weeks. Some participants will receive a placebo instead of oxytocin. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the oxytocin or the placebo during the trial period.

Throughout the study, changes in social behavior and repetitive actions will be monitored and assessed. The study aims to provide insights into whether oxytocin can help improve these behaviors in young people with autism. The trial will last for a total of four weeks, with participants being closely observed to ensure their safety and to gather data on the effects of the treatment.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, you will be asked to provide a signed, written informed consent if you are 16 years or older. If you are between 12 and 15 years old, you will provide assent, and your caregiver will provide consent for your participation.
You will need to confirm your diagnosis of autism spectrum disorder (ASD) using the Autism Diagnostic Observation Schedule (ADOS) and ensure you are in good general physical health.
Step 2
Receiving the medication
You will receive a nasal spray containing oxytocin to be administered intranasally. The dosage is 24 international units (IU) of oxytocin.
The nasal spray should be used twice daily for a duration of four weeks.
Step 3
Monitoring and assessment
Throughout the four-week period, your social behavior and repetitive behavior will be monitored. This will involve completing assessments such as the Social Responsiveness Scale-Second Edition (SRS-2) and the Repetitive Behavior Scale-Revised (RBS-R), which will be completed by your caregiver.
Additionally, your behavioral inflexibility will be assessed using the Behavioral Inflexibility Scale (BIS), also completed by your caregiver.
Step 4
Completion of the study
At the end of the four-week period, your participation in the study will conclude. The data collected from the assessments will be used to evaluate the effects of the oxytocin treatment on your social and repetitive behaviors.

Who can join the trial?

6 criteria

Participants must be male or female and between the ages of 12 and 20, inclusive.
Participants must have a confirmed diagnosis of autism spectrum disorder (ASD) using a specific test called the Autism Diagnostic Observation Schedule (ADOS).
Participants must be in good general physical health, as determined by the study investigator.
Participants must be able to communicate well with the investigator, understand and comply with the study requirements, and understand the oral and written information provided.
Participants aged 16 years and older must provide a signed, written informed consent to participate in the study.
Participants aged 12 to 15 must provide assent (agreement), and their caregivers must provide consent for their participation. Caregivers will also provide consent for research participation.

Who cannot join the trial?

5 criteria

Patients who are not diagnosed with autism spectrum disorder cannot participate.
Patients who are not within the age range of 2 to 3 years old cannot participate.
Patients who are not part of the specified clinical trial group cannot participate.
Patients who are not male or female cannot participate.
Patients who are not considered part of a vulnerable population cannot participate.

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Oslo Universitetssykehus HF
Oslo, Norway

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Investigated drugs

Oxytocin is a hormone that is naturally produced in the body and is often associated with social bonding and emotional connection. In this clinical trial, oxytocin is administered through the nose using a spray. The goal is to see if it can help improve social interactions and reduce repetitive behaviors in young people with autism spectrum disorders. Participants will use the nasal spray twice a day for four weeks to see if there are any changes in their behavior.

What is already known about the treatment

Oxytocin – Oxytocin is administered as a nasal spray, which means it is inhaled through the nose. It is currently being studied in clinical trials for its potential benefits in treating autism spectrum disorder, particularly focusing on improving social interactions and reducing repetitive behaviors. The main therapeutic use being explored is for enhancing social behavior in individuals with autism. At the molecular level, oxytocin works by binding to specific receptors in the brain, which can influence social bonding and emotional responses. It is classified as a hormone and neurotransmitter, known for its role in social bonding and childbirth.

Investigated diseases

Autism spectrum disorder – Autism spectrum disorder is a developmental condition that affects communication, behavior, and social interaction. It typically appears in early childhood and is characterized by challenges in understanding social cues, forming relationships, and engaging in typical social activities. Individuals with autism may exhibit repetitive behaviors, such as hand-flapping or rocking, and may have specific routines or rituals. They might also experience sensory sensitivities, such as being overly sensitive to sounds, lights, or textures. The severity and combination of symptoms can vary widely among individuals, leading to a spectrum of experiences. Over time, some individuals may develop coping strategies and improve their social skills, while others may continue to face significant challenges.