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Study of Oxytocin Nasal Spray as Add-on Treatment for Children with Autism Spectrum Disorder and Intellectual Disability: Safety and Feasibility Assessment

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What is this trial about?

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

This study focuses on children with Autism Spectrum Disorder who also have moderate to severe intellectual disability. The research examines the use of oxytocin nasal spray alongside standard behavioral and educational therapy. Oxytocin is a naturally occurring hormone that may help improve social interaction and behavior in children with autism.

The study aims to determine if it is practical and safe to use oxytocin nasal spray in children aged 6 to 12 years who have severe autism and significant intellectual challenges. During the study, participants will receive either oxytocin nasal spray or a placebo (containing sodium chloride) in addition to their regular therapy. The treatment will be given daily through a nasal spray both at treatment centers and at home.

The treatment period lasts up to 12 weeks, during which children will receive regular medical check-ups. The study will test two different doses of oxytocin (4 and 8 international units) to evaluate how well children tolerate the treatment. Throughout the study, healthcare providers and parents will monitor the children's response to the treatment and any changes in their behavior.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial treatment phase

    You will receive nasal spray treatment containing oxytocin at a dose of 4 IU (International Units)

    The treatment will be administered daily at the medical center and at home

    Regular pediatric examinations will be conducted to monitor your health

  2. Step 2

    Medical monitoring

    Your health will be monitored through regular blood tests

    An electrocardiogram (heart rhythm test) will be performed periodically

    Healthcare providers will assess how well you are tolerating the treatment

  3. Step 3

    Dose adjustment phase

    If the initial treatment is well-tolerated, the dose may be increased to 8 IU

    The nasal spray will continue to be administered daily

    Regular medical check-ups will continue throughout this phase

  4. Step 4

    Ongoing assessment

    Your behavior will be monitored using specific assessment scales

    Parents will need to complete questionnaires about treatment progress

    Healthcare providers will document any changes in your condition

  5. Step 5

    Treatment duration

    The study is scheduled to continue until January 2028

    Your participation will involve regular visits to the medical center

    Any existing medications you take must remain at stable doses throughout the study period

Who can join the trial?

10 criteria

  • Child must be between 6 and 12 years old
  • Child must have autism spectrum disorder of severe intensity, diagnosed using DSM-5 (a standardized diagnostic manual for mental conditions)
  • Child must have moderate to severe intellectual disability and challenging behaviors (confirmed through clinical examination and specific behavioral assessment scales)
  • Child must be receiving ongoing care and support at one of the study centers
  • Child must be covered by a social security scheme
  • Both boys and girls can participate
  • If the child is taking any mental health medications (such as medications for anxiety, sleep, depression, or behavior), the dosage must have been stable for at least 3 months
  • Parents must be able to understand instructions for giving the medication and complete questionnaires
  • Parents must sign an informed consent form giving permission for their child to participate
  • If child is on any psychiatric medications, they must be within recommended dose limits

Who cannot join the trial?

13 criteria

  • Age below 6 years or above 12 years
  • Children without a confirmed diagnosis of Autism Spectrum Disorder (ASD)
  • Children who do not have moderate to severe intellectual disability
  • Known allergies or hypersensitivity to the study medication (nasal spray)
  • Participation in another clinical trial in the past 30 days
  • Inability to follow study procedures or use nasal spray
  • Serious medical conditions that could interfere with the study
  • Current use of medications that could interact with the study treatment
  • Significant nasal problems that would prevent proper use of nasal spray
  • Children whose parents or legal guardians cannot provide informed consent
  • Children who cannot attend regular medical check-ups during the study
  • History of serious heart problems (as confirmed by electrocardiogram, a test that checks heart activity)
  • Inability to provide blood samples for safety monitoring
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Investigated drugs

Oxytocin is a hormone that is being tested as an additional treatment alongside standard psycho-educational therapy. In this trial, it is given as a nasal spray. Oxytocin is being studied for its potential to help manage challenging behaviors in children with autism spectrum disorders and intellectual disabilities. The medication is administered daily, both at the treatment facility and at home. Psycho-educational interventions are structured therapeutic activities that are already used as a standard treatment approach for children with autism spectrum disorders. These interventions focus on teaching social, behavioral, and communication skills while supporting emotional development.

What is already known about the treatment

Oxytocin (intranasal) – A hormone-based medication administered through nasal spray that is being investigated as a potential adjuvant treatment for children with Autism Spectrum Disorders (ASD) and intellectual disabilities. This medication, naturally produced in the brain, is being studied at doses of 4 IU and 8 IU to evaluate its safety and feasibility in managing challenging behaviors when combined with standard psycho-educational interventions. The treatment involves daily administration both at clinical settings and at home, with regular monitoring through pediatric examinations, blood tests, and electrocardiograms to ensure patient safety and optimal therapeutic response.

Investigated diseases

Autism Spectrum Disorder with Intellectual Disability - A complex developmental condition that affects how a person perceives and interacts with the world around them. The disorder combines features of autism spectrum disorder (ASD) with significant limitations in intellectual functioning and adaptive behavior. People with this condition experience challenges in social communication, show repetitive behaviors or restricted interests, and have difficulty with learning and problem-solving skills. The intellectual disability component means they have limitations in both cognitive functioning and daily living skills. This condition typically becomes apparent during early childhood development and affects various aspects of daily life, including social interactions, communication, and learning abilities.
Trial detailsLast updated 7 Oct 2026
Age0-17PhasePhase IVTrial ID2024-516306-28-00Protocol codeRC31/19/0500Estimated enrolment30 patientsSponsorCentre Hospitalier Universitaire De Toulouse

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