Prader-Willi Syndrome
Conditions
Keywords
oxytocin, adults
Brief summary
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.
Interventions
DRUGOxytocin (OXT) continuous
Administration of 24 IU of oxytocin daily during 28 days
DRUGPlacebo
Placebo daily during 28 days
DRUGPlacebo continuous
Placebo administration the following 2 days after each OXT administration, during 28 days.
DRUGOxytocin
Administration of 24 IU of oxytocin every 3 days during 28 days.
Sponsors
University Hospital, Toulouse
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame | Description |
|---|---|---|
| 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) | Day 1, day 2 and day 30 | Brain imaging |
| Cerebral Metabolism variations as assessed by functional Magnetic Resonance Imaging (f-RMI) | Day 1, day 2 and day 29 | Brain imaging |
| 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 | — |
Countries
France
Outcome results
None listed