Oxytocin for Autism spectrum disorder | Intellectual disability

Inclusion criteria

• {"criterion_text":"- Minor benefiting from a social security scheme"}
• {"criterion_text":"- Diagnosis:autism spectrum disorder according to the Diagnostic and Statistical Manual DSM -5 of severe intensity;"}
• {"criterion_text":"- Age: 6 – 12 years (> 5 years and < 13 years)"}
• {"criterion_text":"- Female or male child"}
• {"criterion_text":"- Comorbidities: Moderate to severe intellectual disability // Presence of challenging behavior objectified by means of clinical examination and the ABC and ABC-I scales"}
• {"criterion_text":"- Psycho-educational and re-educative care within one of the 4 investigative centers"}
• {"criterion_text":"- if prescribed psychotropic treatments (antipsychotics, anxiolytics, hypnotics/sedatives, antidepressants, psychostimulants and antiepileptics), the dosages must be stable for 3 months and must be within the recommended dose limits."}
• {"criterion_text":"- 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"}
• {"criterion_text":"- informed consent signed by the holders of parental authority"}

Exclusion criteria

• {"criterion_text":"- The refusal of the holders of parental authority"}
• {"criterion_text":"- History of epilepsy or seizures"}
• {"criterion_text":"- Sexually active women of childbearing age without effective contraception (Combined hormonal contraception (containing estrogens and progestins) combined with inhibition of ovulation or progestin-only hormonal contraception combined with inhibition of ovulation)"}
• {"criterion_text":"- Breastfeeding women"}
• {"criterion_text":"- Severe cardiovascular disease (tachycardia, bradycardia, arrhythmias, hypertension, hypotension, myocardial ischemia)"}
• {"criterion_text":"- Latex allergy"}
• {"criterion_text":"- Pregnant girls, determined by a positive baseline blood pregnancy test"}
• {"criterion_text":"- Criteria respecting the Syntocinon SPC: Hypersensitivity to Syntocinon /// Hyponatremia < 135 mmol/L /// Hypokalaemia < 3.5 mmol/L /// Hypertension or hypotension"}
• {"criterion_text":"- Behavioral intolerance to the intranasal route"}
• {"criterion_text":"- Hepatic impairment (ALT and/or AST > 3N)"}
• {"criterion_text":"- Kidney failure (creatinine > 3 N)"}
• {"criterion_text":"- History of an ECG considered to be clinically significant abnormal (validated by a cardiologist)"}
• {"criterion_text":"- Type 1 or 2 diabetes"}
• {"criterion_text":"- Prolongation of the QT interval and/or family history of QT prolongation linked to an identified genetic etiology (QTc prolongation threshold > 460 ms). Corrected QTc calculated with Bazett's formula: QTc = QTm/ V RR."}

Primary endpoints

• {"endpoint_text":"- The results will be considered positive if this percentage is greater than or equal to 80%, with a lower limit of the confidence interval of this estimate beyond 61.4%.","definition_or_measurement_approach":"Primary result defined as a percentage; success criteria: percentage >= 80% with lower bound of confidence interval > 61.4%."}

Secondary endpoints

• {"endpoint_text":"- Precise statement of the reasons for a possible interruption of the protocol","definition_or_measurement_approach":""}
• {"endpoint_text":"- Qualitative assessment by caregivers and parents of the heaviness of implementing the protocol through semi-directive qualitative and quantitative interviews","definition_or_measurement_approach":"Measured via semi-structured qualitative and quantitative interviews of caregivers and parents."}
• {"endpoint_text":"- Results of the questionnaires","definition_or_measurement_approach":"Assessment based on questionnaire results (details not provided)."}

France

Earliest CTIS Part Ii Submission Date

09-09-2024

Latest Decision Or Authorization Date

19-08-2025

Processing Time Days

344

Number Of Sites

3

Number Of Participants

30

Primary sponsor

Full Name

Centre Hospitalier Universitaire De Toulouse

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France