NCT05864508

Interest of Oxytocin as an Adjuvant Treatment of Psycho-educational Measures in Challenging Behaviors in Children With Autism Spectrum Disorders and Moderate to Severe Intellectual Disability: Feasibility and Safety Study.

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: University Hospital, Toulouse · Academic / Other
• Sex: All
• Age: 6 Years – 12 Years
• Healthy volunteers: Not accepted

Summary

The investigation team propose in this study to specifically evaluate the feasibility of using oxytocin in the form of an intranasal spray in a specific population of children with autism spectrum disorder and intellectual disability. The lack of studies centered on this population on the one hand, and on the other hand the severity of challenging behaviors presented by these children, make questionable the direct transfer of methods of care used in patients who do not present these challenging behavior. In this sense, the establishment of oxytocin treatment in these children requires a preliminary phase of feasibility assessment before being able to consider a comparative trial of the randomized clinical trial type.

Detailed description

Taking into account: * Intellectual disability comorbidity as a risk factor for challenging behaviors in the population with autism spectrum disorder; * behavioral difficulties inherent in the presence of these behaviors, which are all potential obstacles to the administration of a treatment and therefore above all raise the question of the feasibility of administering such a treatment; * the difficulty for children associating autism spectrum disorder of severe intensity and intellectual disability to benefit from clinical and paraclinical examinations given the concern generated by such examinations and challenging behaviors which can then occur in them, raising the question of feasibility monitoring protocol * results of Oxytocin administration obtained in patients with autism spectrum disorder without associated intellectual disability; * the favorable drug safety profile of oxytocin in children with autism spectrum disorder of the same age but without challenging behaviors; * the extreme need for an effective treatment to control challenging behaviors in children with autism spectrum disorder with associated intellectual disability, the investigation team propose in this study to specifically evaluate the feasibility of using oxytocin in the form of an intranasal spray in a specific population of children with autism spectrum disorder and intellectual disability. The lack of studies centered on this population on the one hand, and on the other hand the severity of challenging behaviors presented by these children, make questionable the direct transfer of methods of care used in patients who do not present these challenging behavior. In this sense, the establishment of oxytocin treatment in these children requires a preliminary phase of feasibility assessment before being able to consider a comparative trial of the randomized clinical trial type.

Conditions

• Autism Spectrum Disorder

Interventions

Type	Name	Description
DRUG	Oxytocin nasal spray	intranasal oxytocin treatment once a day during 6 weeks

Timeline

• Start date: 2023-07-01
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2023-05-18
• Last updated: 2023-05-18

Locations

1 site across 1 country: France