Effects of Intranasal Administration of Oxytocin in Adults With Prader-Willi Syndrome

Study Overview
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Brief Summary
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The investigator thinks that the oxytocin (OT) can improve durably and significantly the behavior disorders and thus the socialization but also the satisfaction and could thus be an interesting therapeutic alternative for the patients presenting a Prader-Willi Syndrome (SPW). Although today several studies demonstrated the effects of the OT in various domains of the behavior, the investigator do not know either its specificity of action about the cerebral level, or its duration of action, or the optimal modalities of administration and in particular at patients SPW.

Official Title
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Effects of Intranasal Administration of Oxytocin in Adults With Prader-Willi Syndrome

Conditions
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Prader-Willi Syndrome

Intervention / Treatment
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* Drug: Oxytocin (OXT) continuous
* Drug: Placebo
* Drug: Placebo continuous
* Drug: Oxytocin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Prader-Willi syndrome genetically confirmed Absence of extension of the QT interval in the electrocardiogram Absence of hypokalemia Exclusion Criteria: Psychiatric troubles Anomalies of the heart rhythm in significant ECG Hepatic insufficiency Renal insufficiency Patients presenting a pregnancy or breast-feeding High sensibility to OT High sensibility to the excipients of the product Patients having family history of genetic pathology causing an extension of the interval QT Patients having risk factors of advanced twist

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: placebo daily<br>daily administration of placebo during 28 days : placebo continuous | Drug: Placebo continuous<br>* Placebo administration the following 2 days after each OXT administration, during 28 days.<br>|
| Active Comparator: 24 IU of oxytocin daily<br>24 IU of daily oxytocin administration during 28 days : oxytocin continuous | Drug: Oxytocin (OXT) continuous<br>* Administration of 24 IU of oxytocin daily during 28 days<br>* Other names: Syntocinon;|
| Active Comparator: 24 IU of oxytocin every 3 days<br>24 IU of daily oxytocin every 3 days and placebo the following 2 days after each oxytocin administration during 28 days | Drug: Placebo<br>* Placebo daily during 28 days<br>Drug: Oxytocin<br>* Administration of 24 IU of oxytocin every 3 days during 28 days.<br>* Other names: Syntocinon;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Behaviour as assessed by score variations in specific questionaries |  | Every day before and after administration of treatment during 28 days | 
| Change in eating Behaviour as assessed by score variations in specific questionaries |  | Every day before and after administration of treatment during 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in eating behaviour as assessed by score variations in hunger visual analogic scale |  | Every day before and after administration of treatment during 28 days | 
| Cerebral Metabolism variations as assessed by Positron Emission Tomography (PET-scan) | Brain imaging | Day 1, day 2 and day 30 | 
| Cerebral Metabolism variations as assessed by functional Magnetic Resonance Imaging (f-RMI) | Brain imaging | Day 1, day 2 and day 29 | 
| Evaluation of social skills assessed by specific questionnaires |  | Day 1, day 2 and day 30 | 
| Evaluation of executive function assessed by specific questionnaires |  | Day 1, day 2 and day 30 | 
| Evaluation of theory of mind assessed by specific questionnaires |  | Day 1, day 2 and day 30 | 
| Social processing assessed by oculomotor exploration |  | Day 1, day 2 and day 30 | 
| Multisensory processing assessed by Neurovisual task |  | Day 1, day 2 and day 30 | 
| Hormon blood concentration levels as assessed by bioassays |  | Day 2 and day 30 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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oxytocin, adults