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

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.

Inclusion Criteria:

1. Male or Female child outpatients aged 5 to 18 years

2. Diagnosis of PWS confirmed by genetic testing and patient medical records and history

3. Stable pharmacologic, educational, behavioral and/or dietary interventions for 4 weeks
prior to the study start, and for the duration of the study.

4. Have a physical exam and laboratory results that are within the norms for PWS

5. Have a parent/caregiver/guardian that is able to consent for their participation and
complete assessments regarding the child's development and behavior improvement
throughout the study.

Exclusion Criteria:

1. Exposure to any investigational agent in the 30 days prior to randomization

2. Prior chronic treatment with oxytocin.

3. A primary psychiatric diagnosis other than ASD, including bipolar disorder, psychosis,
schizophrenia, PTSD or major depressive disorder. These patients will be excluded due
to potential confounding results.

4. Pregnant or lactating patients. IN-OXT has not been studied in pregnant or lactating
women.

5. A medical condition that might interfere with the conduct of the study, confound
interpretation of study results or endanger their own well-being.

6. Plan to initiate or change nonpharmacologic or pharmacologic interventions during the
course of the study.

7. Females using an estrogen-based contraceptive. As an alternative to an estrogen based
contraceptive, subjects will be counseled to use progesterone-based contraceptives;
cervical caps; cervical sponges; or spermicidal foam in combination with a condom.
Subjects will need to use a double barrier method to be in the study.