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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)
EU CTIS ID: 2024-516306-28-00
What this study is testing
The main objective of this study is to assess the feasibility of a protocol for administering OT intranasally as an adjuvant drug treatment to standard psycho-educational interventions in children aged 6 to 12 years with ASD of intensity severe and moderate to profound HI and presenting DC, at three levels: 1. The feasibility of setting up the pre-therapeutic and monitoring protocol for OT treatment: regular pediatric examination, taking blood samples, carrying out an electrocardiogram; 2. The feasibility of administering a daily OT intranasal spray treatment at the point of care and at home; 3. The safety profile of the medicinal product in this specific population at the two doses (4 IU then 8 IU).
- Phase II and Phase III (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Minor benefiting from a social security scheme
- Diagnosis:autism spectrum disorder according to the Diagnostic and Statistical Manual DSM -5 of severe intensity;
- Age: 6 – 12 years (> 5 years and < 13 years)
- Female or male child
- Comorbidities: Moderate to severe intellectual disability // Presence of challenging behavior objectified by means of clinical examination and the ABC and ABC-I scales
- Psycho-educational and re-educative care within one of the 4 investigative centers
You likely can't join if
- The refusal of the holders of parental authority
- History of epilepsy or seizures
- 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)
- Breastfeeding women
- Severe cardiovascular disease (tachycardia, bradycardia, arrhythmias, hypertension, hypotension, myocardial ischemia)
- Latex allergy
See the full eligibility criteria
- Minor benefiting from a social security scheme
- Diagnosis:autism spectrum disorder according to the Diagnostic and Statistical Manual DSM -5 of severe intensity;
- Age: 6 – 12 years (> 5 years and < 13 years)
- Female or male child
- Comorbidities: Moderate to severe intellectual disability // Presence of challenging behavior objectified by means of clinical examination and the ABC and ABC-I scales
- Psycho-educational and re-educative care within one of the 4 investigative centers
- 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.
- 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
- The refusal of the holders of parental authority
- History of epilepsy or seizures
- 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)
- Breastfeeding women
- Severe cardiovascular disease (tachycardia, bradycardia, arrhythmias, hypertension, hypotension, myocardial ischemia)
- Latex allergy
- 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). Corrected QTc calculated with Bazett's formula: QTc = QTm/ V RR.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.