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

University Hospital, Toulouse50 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Prader-Willi Syndrome

Interventions

Oxytocin (OXT) continuousDRUG

Administration of 24 IU of oxytocin daily during 28 days

PlaceboDRUG

Placebo daily during 28 days

Placebo continuousDRUG

Placebo administration the following 2 days after each OXT administration, during 28 days.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 Years

Medical Language ↔ Plain English

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

Locations (1)

Centre de référence Prader-Willi - Hôpital Purpan

Toulouse, France

Outcomes

Primary Outcomes

Change in Behaviour as assessed by score variations in specific questionaries

Time frame: Every day before and after administration of treatment during 28 days

Change in eating Behaviour as assessed by score variations in specific questionaries

Time frame: Every day before and after administration of treatment during 28 days

Secondary Outcomes

Change in eating behaviour as assessed by score variations in hunger visual analogic scale

Time frame: Every day before and after administration of treatment during 28 days

Cerebral Metabolism variations as assessed by Positron Emission Tomography (PET-scan)

Brain imaging