Comparative Study Between Prader-Willi Patients Who Take Oxytocin Versus Placebo

• Status: Completed
• Trial end date: 2009-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The role of oxytocin (OT) is already known in the regulation of satiety but some clinical studies demonstrated that OT participates also in the regulation of social behavior by its implication on a better comprehension of emotion which plays a role on theory of mind and empathy. By the way, these 2 behaviors are deviants for patients with Prader-Willi Syndrome (PWS). Actually, no study was led on the effect of OT on PWS patients but Swaab and al in 1995 showed a significant reduction in number and in volume of neurons expressing OT in the paraventricular nucleus of PWS patients. Recent data were obtained studying OT in patients with autism which showed a link between the deregulation of OT and the autistic pathology. Clinical and imaging studies obtained with PWS and autistic populations make us believe that some mechanisms are common between these two pathologies.

The objectives of this project are:

1. to look for an influence on the understanding of the social codes of the PWS patients,

2. to look for an influence on the behavior of stress and anxiety and on the regulation of eating habits when patients receive a nasal pulverizing of OT.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Toulouse
• Treatments: Oxytocin

Criteria

Inclusion Criteria:

• PWS genetically confirmed,

• Age 18-year-old superior,

• Negative pregnancy test.

Exclusion Criteria:

• Severe psychiatric troubles

• Problem administration staff,

• Saving of justice,

• Abnormalities of the heart rhythm,

• Hepatic or renal insufficiency,

• Pregnancy,

• Oxytocin hypersensibility,

• Treatment causing rhythm disorders.