Clinical Trial: Oxytocin Trial in Prader-Willi Syndrome

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Oxytocin Trial in Prader-Willi Syndrome

Brief Summary:

Individuals with Prader-Willi syndrome (PWS) have been found to have a deficit of oxytocin-producing neurons and decreased oxytocin receptor gene function, so the purpose of this study is to determine if oxytocin (OT) administration will improve some of the aspects of Prader-Willi syndrome that are particularly troublesome for children and their families (the insatiable appetite and social behaviors).

The research questions are:

  1. Does intranasal oxytocin cause any side effects in children with PWS?
  2. Does intranasal oxytocin administration alter appetite or behaviors in PWS?

Detailed Summary: This study is to investigate if intranasal oxytocin will improve hyperphagia, social skills, and behaviors in subjects with Prader-Willi syndrome. This will be a randomized placebo controlled pilot study. The primary outcome measure is to determine if intranasal administration of oxytocin will cause any adverse events in subjects with Prader-Willi syndrome. Secondarily, the investigators will also perform evaluations to determine if intranasal oxytocin has any effect on social skills, behaviors, or appetite in children with Prader-Willi syndrome.
Sponsor: University of Florida

Current Primary Outcome: Safety of intranasal oxytocin in children with Prader-Willi syndrome [ Time Frame: 3 months ]

Occurrence of adverse event, description and quantification of clinical and behavior severity, pre- and post- intranasal oxytocin and placebo administration.


Original Primary Outcome: Safety of intranasal oxytocin in children with Prader-Willi syndrome [ Time Frame: 6 months ]

Occurrence of adverse event, description and quantification of clinical and behavior severity, pre- and post- intranasal oxytocin and placebo administration.


Current Secondary Outcome: Evaluation of food intake in Prader-Willi syndrome [ Time Frame: 3 months ]

Quantitative evaluation of hyperphagia via the Hyperphagia Questionnaire obtained on days 1, 4 and 6 during the 7 day study protocol and conducted in the evening on these days. Score will range from 0 (no hyperphagia behaviors) to 96 (most severe hyperphagia behaviors). Additionally quantity of food consumed will be recorded on Days 1,4, and 6.


Original Secondary Outcome: Evaluation of food intake in Prader-Willi syndrome [ Time Frame: 6 months ]

Quantitative evaluation of hyperphagia via the Hyperphagia Questionnaire obtained on days 1, 4 and 6 during the 7 day study protocol and conducted in the evening on these days. Score will range from 0 (no hyperphagia behaviors) to 96 (most severe hyperphagia behaviors). Additionally quantity of food consumed will be recorded on Days 1,4, and 6.


Information By: University of Florida

Dates:
Date Received: December 11, 2013
Date Started: March 2015
Date Completion:
Last Updated: September 17, 2015
Last Verified: September 2015