Study of Oxytocin Nasal Spray as Add-on Treatment for Children with Autism Spectrum Disorder and Intellectual Disability: Safety and Feasibility Assessment
This trial is investigating whether oxytocin nasal spray can be used safely and effectively alongside regular behavioral and educational therapy for children with autism spectrum disorder and moderate to severe intellectual disability. The study is being conducted in France.
Who can participate:
- Children between 6 and 12 years old (both boys and girls)
- Children diagnosed with severe autism spectrum disorder according to DSM-5 criteria
- Children with moderate to severe intellectual disability and challenging behaviors
- Children who are already receiving ongoing care at one of the study centers
- Children covered by a social security scheme
- If taking mental health medications, the dose must have been stable for at least 3 months
- Parents must be able to understand instructions for administering the medication and complete questionnaires
- Parents must provide written informed consent
Who cannot participate:
- Children younger than 6 years or older than 12 years
- Children without a confirmed autism spectrum disorder diagnosis
- Children who do not have moderate to severe intellectual disability
- Children with known allergies to the study medication
- Children who have participated in another clinical trial within the past 30 days
- Children who cannot follow study procedures or use the nasal spray
- Children with serious medical conditions that could interfere with the study
- Children with significant nasal problems
- Children with a history of serious heart problems
- Children whose parents cannot attend regular check-ups during the study
What the trial involves:
The main focus of this trial is to determine whether oxytocin nasal spray is safe and practical to use in children aged 6 to 12 years who have severe autism and significant intellectual challenges. Oxytocin is a naturally occurring hormone that researchers believe may help improve social interaction and behavior in children with autism.
During the study, children will receive either oxytocin nasal spray or a placebo (containing sodium chloride) in addition to their regular therapy. The nasal spray will be given daily, both at the treatment center and at home. The treatment period lasts up to 12 weeks.
The study tests two different doses of oxytocin: initially 4 international units (IU), and if well-tolerated, the dose may be increased to 8 IU. Throughout the study, children will receive regular medical check-ups including:
- Pediatric examinations
- Blood tests to monitor health
- Electrocardiograms to check heart rhythm
- Behavioral assessments using specific scales
Parents will also need to complete questionnaires about their child's progress and any changes in behavior. Healthcare providers will closely monitor how well children tolerate the treatment and document any changes in their condition.
Investigational treatment:
The trial is testing oxytocin nasal spray as an add-on treatment to standard psycho-educational therapy. Oxytocin is a hormone being studied for its potential to help manage challenging behaviors in children with autism spectrum disorders and intellectual disabilities. It is administered daily through a nasal spray at doses of either 4 IU or 8 IU.
Psycho-educational interventions, which are already standard treatment for children with autism, are structured therapeutic activities that focus on teaching social, behavioral, and communication skills while supporting emotional development.
France