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NOT YET RECRUITING

NCT05864508

PHASE2

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.

Sponsor: University Hospital, Toulouse

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

6 Years - 12 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2023-07

Completion Date

2026-12

Last Updated

2023-05-18

Healthy Volunteers

Conditions

Autism Spectrum Disorder

Interventions

DRUG

Oxytocin nasal spray

intranasal oxytocin treatment once a day during 6 weeks

Inclusion Criteria: * Minor benefiting from a social security scheme. * Diagnosis:autism spectrum disorder according to the Diagnostic and Statistical Manual DSM -5 of severe intensity; * Comorbidities: * Moderate to severe intellectual disability * Presence of challenging behavior objectified by means of clinical examination and the ABC and ABC-I scales * Multi-professional psycho-educational and re-educational care : global and coordinated interventions associating, according to the needs, educational interventions by targeted objectives, therapeutic interventions involving functions that do not develop spontaneously, adaptation of the environment by structuring time and space, in close collaboration with the families. * If prescribed psychotropic treatments (antipsychotics, anxiolytics, hypnotics/sedatives, antidepressants, psychostimulants and antiepileptics), the dosages must be stable for 3 months\* * Understanding of French by both parents (if applicable) and ability for both parents to understand, in particular, the instructions for administering the product and to answer questionnaires. * Informed consent signed by the holders of parental authority Exclusion Criteria: * The refusal of the holders of parental authority * Pregnant girls, determined by a positive baseline blood pregnancy test * Criteria respecting the Syntocinon SPC: * Hypersensitivity to Syntocinon * Hyponatremia \< 135 mmol/L * Hypokalaemia \< 3.5 mmol/L * Hypertension or hypotension * Behavioral intolerance to the intranasal route * Hepatic impairment (ALT and/or AST \> 3N) * Kidney failure (creatinine \> 3 N) * History of an ECG considered to be clinically significant abnormal (validated by a cardiologist) * Type 1 or 2 diabetes * Prolongation of the QT interval and/or family history of QT prolongation linked to an identified genetic etiology (QTc prolongation threshold \> 460 ms). \*\* * History of epilepsy or seizures * Sexually active women of childbearing age without effective contraception\* * Breastfeeding women * Severe cardiovascular disease (tachycardia, bradycardia, arrhythmias, hypertension, hypotension, myocardial ischemia) * Latex allergy

Locations (1)

Toulouse University hospital

Toulouse, France