Conditions: Prader-Willi Syndrome Hyperphagia
Keywords: Prader-Willi Syndrome (PWS) Hyperphagia
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 23
Healthy volunteers: no

Brief summary:
The investigators propose a randomized double-blind 8 week treatment trial of intranasal oxytocin (IN-OXT) vs. placebo in 24 subjects aged 5 to 18 years with PWS in order to assess IN-OXT's affect on (1) Eating behaviors (2) Repetitive and disruptive behaviors and (3) Salivary OXT levels.

Detailed description:
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. 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 on (1) Eating behaviors (2) Repetitive and disruptive behaviors and (3) Salivary OXT levels. 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.

Arms:
arm 1: Participants were instructed to take 16 IU/per day everyday (2 puffs per nostril, 4 IU each puff). arm 2: Participants were instructed to take 16 IU/per day everyday (2 puffs per nostril, 4 IU each puff).

Interventions: intervention 1: Intranasal Oxytocin (IN-OXT) intervention 2: Matched Placebo
Intervention descriptions: intervention 1: Participants were instructed to take 16 IU/per day everyday (2 puffs per nostril, 4 IU each puff). intervention 2: Participants were instructed to take 16 IU/per day everyday (2 puffs per nostril, 4 IU each puff).

Protocol document: