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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| placebo daily | Placebo Comparator | daily administration of placebo during 28 days : placebo continuous |
|
| 24 IU of oxytocin daily | Active Comparator | 24 IU of daily oxytocin administration during 28 days : oxytocin continuous |
|
| 24 IU of oxytocin every 3 days | Active Comparator | 24 IU of daily oxytocin every 3 days and placebo the following 2 days after each oxytocin administration during 28 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxytocin (OXT) continuous | Drug | Administration of 24 IU of oxytocin daily during 28 days |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maithé TAUBER, MD | University Hospital, Toulouse | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre de référence Prader-Willi - Hôpital Purpan | Toulouse | 31059 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26994593 | Result | Salles J, Strelnikov K, Carine M, Denise T, Laurier V, Molinas C, Tauber M, Barone P. Deficits in voice and multisensory processing in patients with Prader-Willi syndrome. Neuropsychologia. 2016 May;85:137-47. doi: 10.1016/j.neuropsychologia.2016.03.015. Epub 2016 Mar 16. |
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| ID | Term |
|---|---|
| D011218 | Prader-Willi Syndrome |
| ID | Term |
|---|---|
| D008607 | Intellectual Disability |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D010121 | Oxytocin |
| ID | Term |
|---|---|
| D010909 | Pituitary Hormones, Posterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
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| Placebo | Drug | Placebo daily during 28 days |
|
| Placebo continuous | Drug | Placebo administration the following 2 days after each OXT administration, during 28 days. |
|
| Oxytocin | Drug | Administration of 24 IU of oxytocin every 3 days during 28 days. |
|
|
| 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 |
| D000015 | Abnormalities, Multiple |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D025063 | Chromosome Disorders |
| D030342 | Genetic Diseases, Inborn |
| D000096803 | Imprinting Disorders |
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D006730 |
| Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |