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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)

Primary Purpose

Autism Spectrum Disorder

Status
Not yet recruiting
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Oxytocin nasal spray
Sponsored by
University Hospital, Toulouse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism Spectrum Disorder focused on measuring Autism Spectrum disorder, Oxytocin, Intellectual disability, Challenging behavior

Eligibility Criteria

6 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Toulouse University hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

intranasal oxytocin

Arm Description

intranasal oxytocin treatment once a day during 6 weeks

Outcomes

Primary Outcome Measures

percentage of children with complete OT administration protocol
percentage of children who will complete the OT administration protocol
percentage of children with complete monitoring protocol
percentage of children who will complete the monitoring protocol

Secondary Outcome Measures

Full Information

First Posted
May 9, 2023
Last Updated
May 9, 2023
Sponsor
University Hospital, Toulouse
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1. Study Identification

Unique Protocol Identification Number
NCT05864508
Brief Title
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.
Acronym
OT-DEFI
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 2023 (Anticipated)
Primary Completion Date
December 2026 (Anticipated)
Study Completion Date
December 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder
Keywords
Autism Spectrum disorder, Oxytocin, Intellectual disability, Challenging behavior

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
intranasal oxytocin
Arm Type
Experimental
Arm Description
intranasal oxytocin treatment once a day during 6 weeks
Intervention Type
Drug
Intervention Name(s)
Oxytocin nasal spray
Intervention Description
intranasal oxytocin treatment once a day during 6 weeks
Primary Outcome Measure Information:
Title
percentage of children with complete OT administration protocol
Description
percentage of children who will complete the OT administration protocol
Time Frame
Week 14
Title
percentage of children with complete monitoring protocol
Description
percentage of children who will complete the monitoring protocol
Time Frame
week 14

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Julie ANDANSON, MD
Phone
05 61 77 80 75
Ext
+33
Email
andanson.j@chu-toulouse.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Alexis REVET, MD, PhD
Email
revet.a@chu-toulouse.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julie ANDANSON, MD
Organizational Affiliation
Toulouse University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Toulouse University hospital
City
Toulouse
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julie ANDANSON, MD
Email
andanson.j@chu-toulouse.fr
First Name & Middle Initial & Last Name & Degree
Alexis REVET, MD, PHD
Email
revet.a@chu-toulouse.fr
First Name & Middle Initial & Last Name & Degree
Julie ANDANSON, MD
First Name & Middle Initial & Last Name & Degree
Alexis REVET, MD, PHD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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.

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