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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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.

Detailed Summary:
Sponsor: University Hospital, Toulouse

Current Primary Outcome:

  • 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 ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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) [ Time Frame: Day 1, day 2 and day 30 ]
    Brain imaging
  • Cerebral Metabolism variations as assessed by functional Magnetic Resonance Imaging (f-RMI) [ Time Frame: Day 1, day 2 and day 29 ]
    Brain imaging
  • Evaluation of social skills assessed by specific questionnaires [ Time Frame: Day 1, day 2 and day 30 ]
  • Evaluation of executive function assessed by specific questionnaires [ Time Frame: Day 1, day 2 and day 30 ]
  • Evaluation of theory of mind assessed by specific questionnaires [ Time Frame: Day 1, day 2 and day 30 ]
  • Social processing assessed by oculomotor exploration [ Time Frame: Day 1, day 2 and day 30 ]
  • Multisensory processing assessed by Neurovisual task [ Time Frame: Day 1, day 2 and day 30 ]
  • Hormon blood concentration levels as assessed by bioassays [ Time Frame: Day 2 and day 30 ]


Original Secondary Outcome: Same as current

Information By: University Hospital, Toulouse

Dates:
Date Received: July 10, 2015
Date Started: June 2014
Date Completion: July 2016
Last Updated: June 14, 2016
Last Verified: June 2016