Clinical Trial: Oxytocin Intranasal Administrations in Children With Prader-Willi Syndrome Aged From 3 to 12 Years

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

Official Title: Effects of Intranasal Administrations of Oxytocin on Behavioural Troubles, Hyperphagia and Social Skills in Children With Prader-Willi Syndrome Aged From 3 to 12 Years.

Brief Summary: Positive results in preclinical and clinical studies in adults and infants with Prader-Willi syndrome lead investigators to set up a new study in children with Prader-Willi syndrome. The objective of this study is to document effects of oxytocin intranasal administrations on behavioural troubles in children with Prader-Willi syndrome aged from 3 to 12 years.

Detailed Summary: Two groups of patients will be constituted according to their age; "Group 1" children aged from 3 to 6 years (n = 20) and "Group 2" children aged from 7 to 12 years (n = 20). Within each group, subjects will be randomized to receive either oxytocin or placebo for 12 consecutive weeks. A second period of 12 consecutive oxytocin treatment weeks will then be performed for all patients, followed by a 4-week observation period to document effects after discontinuation of treatment.
Sponsor: University Hospital, Toulouse

Current Primary Outcome: Evolution of behavioural troubles evaluated by the global score of Child Behavior Check List Questionnaire after 12 weeks of oxytocin/placebo treatment. [ Time Frame: Week 12 ]

It's variation between inclusion and 12 weeks of total score total problems from the Child Behavior Check List Questionnaire.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Evaluation of hyperphagia after 12 weeks of oxytocin/placebo treatment. [ Time Frame: Week 12 ]
    It is the variation of each of the three sub-scores obtained from the Dykens hyperphagia questionnaire between day 0 and week 12.
  • Evaluation of social skills after 12 weeks of oxytocin/placebo treatment. [ Time Frame: Week 12 ]
    It is variation between day 0 and week 12 of the total score obtained from the social skills assessment questionnaire for children aged from 3 to 6 years and the Social Responsiveness Scale questionnaire for children aged from 7 to 12 years.
  • Evaluation of auto- and hetero-aggressive after 12 weeks of oxytocin/placebo treatment. [ Time Frame: Week 12 ]
    It is variation between day 0 and week 12 of the total score obtained from the self-aggression assessment questionnaire.
  • Evaluation of psychopathology after 12 weeks of oxytocin/placebo treatment. [ Time Frame: Week 12 ]
    It is the variation of the following sub-scores obtained from the Child Behaviour Check List questionnaire (only the following 3 subscales) between day 0 and week 12.
  • Evaluation of global clinical status after 12 weeks of oxytocin/placebo treatment. [ Time Frame: Weeks 12 ]

    It is improvement of the patient's overall clinical condition after 12 weeks of treatment with oxytocin/placebo. It's assessed by the Clinical Global Impression Scale's score.

    This scale of improvement of Clinical Global Impression is a 7-point ordinal qualitative scale of "very greatly improved" rated + 3 to "very strongly aggravated" rated -3. The result is expressed in total score which varies from -3 to +3.

  • Evaluation of acyl and desacyl ghrelin plasma levels after 12 weeks of oxytocin/placebo treatment. [ Time Frame: Week 12 ]
    It is evolution of circulating levels of acylated and deacylated ghrelin will be the variations of these rates and the variation of the relationships between day 0 and week 12.
  • Evaluation of attentional abilities after 12 weeks of oxytocin/placebo treatment, for patients aged from 7 to 12 years at inclusion. [ Time Frame: Week 12 ]
    It is evolution of attentional abilities is evaluated by a computerized test, the Attention Network Test.
  • Evaluation of metabolic brain resting state after 12 weeks of oxytocin/placebo treatment, for patients aged from 7 to 12 years at inclusion. [ Time Frame: Week 12 ]
    It is evolution of metabolic brain resting state is evaluated by a magnetic resonance imaging to study the cerebral metabolism between day 0 and week 12.


Original Secondary Outcome: Same as current

Information By: University Hospital, Toulouse

Dates:
Date Received: March 10, 2017
Date Started: November 28, 2016
Date Completion: December 2019
Last Updated: May 2, 2017
Last Verified: May 2017