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. (OT-DEFI)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Autism Spectrum Disorder
• Intervention / Treatment: Drug: Oxytocin nasal spray

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.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Julie ANDANSON, MD; Phone Number: +33 05 61 77 80 75; Email: andanson.j@chu-toulouse.fr
• Study Contact Backup: Name: Alexis REVET, MD, PHD; Email: revet.a@chu-toulouse.fr

Study Locations

• France
  • Toulouse, France
    • Toulouse University Hospital
    • Contact: Alexis REVET, MD, PHD; Email: revet.a@chu-toulouse.fr
    • Contact: Julie ANDANSON, MD; Email: andanson.j@chu-toulouse.fr
    • Principal Investigator: Julie ANDANSON, MD
    • Sub-Investigator: Alexis REVET, MD, PHD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: intranasal oxytocin; intranasal oxytocin treatment once a day during 6 weeks	Drug: Oxytocin nasal spray; intranasal oxytocin treatment once a day during 6 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse
• Investigators: Principal Investigator: Julie ANDANSON, MD, Toulouse University Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2023
• Primary Completion (Anticipated): December 1, 2026
• Study Completion (Anticipated): December 1, 2026

Study Registration Dates

• First Submitted: May 9, 2023
• First Submitted That Met QC Criteria: May 9, 2023
• First Posted (Actual): May 18, 2023

Study Record Updates

• Last Update Posted (Actual): May 18, 2023
• Last Update Submitted That Met QC Criteria: May 9, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Oxytocin; Intellectual disability; Challenging behavior; Autism Spectrum disorder
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Neurodevelopmental Disorders; Disease; Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive; Intellectual Disability; Physiological Effects of Drugs; Reproductive Control Agents; Oxytocics; Oxytocin
• Other Study ID Numbers: RC31/19/0500; 2022-000254-28 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No