Clinical Trial: Oxytocin vs. Placebo for the Treatment Hyperphagia in Children and Adolescents With Prader-Willi Syndrome

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Oxytocin vs. Placebo for the Treatment Hyperphagia in Children and Adolescents With Prader-Willi Syndrome

Brief Summary: The investigators propose a randomized double blind 8 week treatment trial of intranasal OXT vs. placebo in 24 subjects aged 5 to 18 years with PWS in order to assess IN-OXT's affect (1) Eating behaviors (2) Repetitive and disruptive behaviors (3) social cognition measures and (4) Salivary OXT levels and plasma levels of ghrelin, pancreatic polypeptide and leptin. The investigators will determine if IN-OXT reduces eating behaviors in addition to improving social cognition and reducing repetitive/disruptive behaviors in children with PWS. If superior to placebo, this data will add to the current knowledge that OXT is an effective treatment for hyperphagia as well as other problematic symptomatology of PWS.

Detailed Summary:

The investigators propose to conduct a treatment study of intranasal oxytocin (IN-OXT) vs. placebo in children and adolescents with Prader-Willi Syndrome (PWS). OXT has already been proven safe and effective in a treatment study of socialization and disruptive behavior in adults with PWS and is being used in infants with PWS in an ongoing clinical trial. The investigators hypothesize that OXT will be superior to placebo and have a positive effect on child and adolescent PWS eating and repetitive behaviors, and social cognition. If proven superior, this data will add to the current knowledge that OXT is a beneficial treatment with minimal side effects for PWS symptoms. Additional knowledge of OXT's ability to reduce overeating could lead to improvement of patient's quality of life and physical health and reduction in familial stress.

The investigators propose a randomized double blind 8 week treatment trial of intranasal OXT vs. placebo in 24 subjects aged 5 to 18 years with PWS in order to assess IN-OXT's affect (1) Eating behaviors (2) Repetitive and disruptive behaviors (3) social cognition measures and (4) Salivary OXT levels and plasma levels of ghrelin, pancreatic polypeptide and leptin. The investigators will determine if IN-OXT reduces eating behaviors in addition to improving social cognition and reducing repetitive/disruptive behaviors in children with PWS. If superior to placebo, this data will add to the current knowledge that OXT is an effective treatment for hyperphagia as well as other problematic symptomatology of PWS.


Sponsor: Montefiore Medical Center

Current Primary Outcome: Change in Revised Dykens Hyperphagia Scale from Baseline to Endpoint. [ Time Frame: From Randomization at Baseline until Endpoint at Week 8 (Change over 8 weeks) ]

Assesses Eating Behaviors and Hyperphagia in PWS. Repeated Measures Analysis.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change in Repetitive Behavior Scale (RBS-R) from Baseline to Endpoint. [ Time Frame: From Randomization at Baseline until Endpoint at Week 8 (Change over 8 weeks) ]
    Repeated Measures Analysis.
  • Change in Children's Yale-Brown Obsessive Compulsive Scale (CYBOCS) from Baseline to Endpoint. [ Time Frame: From Randomization at Baseline until Endpoint at Week 8 (Change over 8 weeks) ]
    Repeated Measures Analysis.
  • Change in Aberrant Behavior Checklist (ABC) from Baseline to Endpoint. [ Time Frame: From Randomization at Baseline until Endpoint at Week 8 (Change over 8 weeks) ]
    Repeated Measures Analysis.
  • Change in Social Responsiveness Scale (SRS) from Baseline to Endpoint. [ Time Frame: From Randomization at Baseline until Endpoint at Week 8 (Change over 8 weeks) ]
    Repeated Measures Analysis.


Original Secondary Outcome: Same as current

Information By: Montefiore Medical Center

Dates:
Date Received: October 18, 2015
Date Started: October 2015
Date Completion: May 2017
Last Updated: March 8, 2017
Last Verified: March 2017