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Study on Oxytocin Treatment for Children with Autism and Intellectual Disability

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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 evaluating a treatment for children with Autism Spectrum Disorder (ASD) and an intellectual disability. The treatment being studied is a nasal spray called Syntocinon, which contains the active ingredient oxytocin. Oxytocin is a hormone that is naturally produced in the body and is known to play a role in social bonding and stress reduction. The study aims to assess how effective this treatment is in improving core symptoms of autism, such as social interaction and communication, as well as reducing stress levels in children with ASD and intellectual disabilities.

During the study, children will receive multiple doses of the oxytocin nasal spray over a period of time. The effects of the treatment will be monitored through various assessments, including observations of social communication changes and evaluations of autism symptoms by parents, caregivers, and teachers. Additionally, the study will measure stress levels using heart rate variability, which is a way to assess how the heart responds to stress. The study will also look at other aspects of behavior, such as repetitive behaviors, adaptive behavior, and sleep habits, to get a comprehensive understanding of the treatment's impact.

The purpose of this study is to determine whether oxytocin can help improve the quality of life for children with autism and intellectual disabilities by addressing some of the core challenges they face. The study will provide valuable insights into the potential benefits of oxytocin as a treatment option for these conditions.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
The study involves children aged 4 to 13 years with a diagnosis of autism spectrum disorder (ASD) and intellectual disability. Only premenstrual girls are included, but those who begin menstruation during the trial may continue.
Participants must be enrolled in a special needs school or meet criteria for intellectual disability, with an IQ below 75 and an ABAS score below 70.
Step 2
Treatment administration
The treatment involves the administration of oxytocin using a nasal spray. The specific product used is Syntocinon 40 IE/ml nasal spray, solution.
The dosage and frequency of administration are determined by the study protocol, focusing on evaluating the effects of multiple doses.
Step 3
Evaluation of symptoms
The main objective is to assess the effectiveness of oxytocin on core autism symptoms using standardized assessments.
Behavioral measurements of core autism symptoms and cardio electrophysiological measurements of stress are conducted to observe changes from baseline after oxytocin administration.
Step 4
Primary assessments
The primary assessments include the Brief Observation of Social Communication Change (BOSCC), the Autism Treatment Evaluation Checklist (ATEC), and recordings of electrocardiography (ECG) for heart rate variability (HRV) during rest.
Step 5
Secondary assessments
Secondary assessments involve the Repetitive Behavior Scale - Revised (RBS-R), the Adaptive Behavior Assessment System (ABAS-3), the Developmental Behaviour Checklist (DBC), the Perceived Stress Scale (PSS), and the Child’s Sleep Habits Questionnaire Abbreviated (CSHQ-A).
Step 6
Trial duration
The estimated end date for the trial is March 1, 2026. The recruitment for the study began on October 1, 2023.

Who can join the trial?

6 criteria

Children must be between 4 and 13 years old.
Children must have a clinical diagnosis of Autism Spectrum Disorder (ASD). This means they have been diagnosed by a team of healthcare professionals with expertise in autism.
Only girls who have not started menstruating will be included. If a girl starts menstruating during the trial, she can continue with the treatment.
Children must be attending a special needs school. Specifically, they should be in a class with other children who have an intellectual disability. This means they have difficulties with learning and understanding.
Children must have an IQ (a measure of intelligence) below 75. This indicates a level of intellectual disability.
Children must have an ABAS score below 70. The ABAS score measures daily living skills, and a score below 70 suggests challenges in these areas.

Who cannot join the trial?

5 criteria

Children 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.
Children who do not have a comorbid condition of Intellectual Disability (ID) cannot participate. ID is a condition characterized by limitations in intellectual functioning and adaptive behavior.
Children who are not within the specified age range for the study cannot participate. The study is for a specific age group.
Children who are not able to undergo the required assessments and measurements for the study cannot participate. These assessments are necessary to evaluate the effects of the treatment.
Children who are not able to follow the study procedures or comply with the study requirements cannot participate. This includes attending scheduled visits and taking the study medication as directed.

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Katholieke Universiteit te Leuven
Leuven, Belgium

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Investigated drugs

Oxytocin is a hormone that is being studied for its potential effects on social behaviors and stress levels in children with autism and intellectual disability. In this clinical trial, oxytocin is administered in multiple doses to evaluate its impact on core autism symptoms, such as social interactions and stress responses. The goal is to determine if oxytocin can improve these symptoms in children with these conditions.

Oxytocin

What is already known about the treatment

Oxytocin – Oxytocin is administered as a nasal spray, allowing for easy application directly into the nasal cavity. It is currently being studied in clinical trials for its potential benefits in treating autism spectrum disorder (ASD) and intellectual disability. The main therapeutic indication is to improve social behaviors and reduce stress in children with ASD. At the molecular level, oxytocin works by binding to oxytocin receptors in the brain, which can influence social bonding and stress responses. It is classified as a neuropeptide hormone.

Investigated diseases

Autism Spectrum Disorder (ASD) – Autism Spectrum Disorder is a developmental condition that affects communication and behavior. Individuals with ASD may have difficulty with social interactions and may exhibit repetitive behaviors or have restricted interests. The symptoms can vary widely in severity and may include challenges in understanding social cues, maintaining eye contact, and forming relationships. Some individuals may also experience sensory sensitivities, such as being overly sensitive to sounds or textures. The condition is typically diagnosed in early childhood, although signs can sometimes be observed earlier. ASD is a lifelong condition, but the symptoms can change over time, and individuals may develop coping strategies to manage their challenges.