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.



France