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.

NCT05864508 | Not Yet Recruiting Phase 2

• 2 other identifiers: RC31/19/05002022-000254-28
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Autism Spectrum Disorder

Keywords

Autism Spectrum disorder; Oxytocin; Intellectual disability; Challenging behavior

Outcome Measures

Primary Outcomes (2)

• percentage of children with complete OT administration protocol

  percentage of children who will complete the OT administration protocol

  Week 14

• percentage of children with complete monitoring protocol

  percentage of children who will complete the monitoring protocol

  week 14

Study Arms (1)

intranasal oxytocin

EXPERIMENTAL

intranasal oxytocin treatment once a day during 6 weeks

Drug: Oxytocin nasal spray

Interventions

Oxytocin nasal spray DRUG

intranasal oxytocin treatment once a day during 6 weeks

intranasal oxytocin

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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\*

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

Toulouse University hospital

Toulouse, France

Location

MeSH Terms

Conditions

Autism Spectrum Disorder; Intellectual Disability

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Julie ANDANSON, MD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Julie ANDANSON, MD

CONTACT

05 61 77 80 75; andanson.j@chu-toulouse.fr

Alexis REVET, MD, PhD

CONTACT

revet.a@chu-toulouse.fr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2023
• First Posted: May 18, 2023
• Study Start: July 1, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 18, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)