Intranasal administration of oxytocin in children with Prader-Willi Syndrome. A randomized, open-label, cross-over trial of different treatment regimens of oxytocin administration. Effects on eating behaviour and social behaviour.

Withdrawn

Conditions: Prader-Willi Syndrome
10083624

Registration Number: NL-OMON43050

Lead Sponsor: Stichting Kind en Groei

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 44

Inclusion Criteria

In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- Genetically confirmed diagnosis of Prader-Willi syndrome
- Age between 3 and 16 years
- Currently on growth hormone treatment for at least 1 year
- Behavioural problems (for example temper tantrums and autistic behaviour) and/or be in nutritional phase 2b or 3 according to Miller.;For fMRI: age > 6 years

Exclusion Criteria

- Severe psychiatric problems
- Non-cooperatieve behaviour
- Allergic reactions or hypersensitivity for oxytocin
- Serious illness
- Cardiac abnormalities
- Extremely low dietary intake or less than minimal required intake acoording to WHO
- Medication to reduce weight (fat)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The effect of different dosing regimens of intranasal oxytocin administration<br /><br>on changes in social behaviour assessed by the oxytocin study questionnaire. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The effect of different dosing regimens of intranasal oxytocin administration<br /><br>on changes in:<br /><br>- Body composition (anthropometric measurements, BMI and DXA-scan)<br /><br>- Quality of life (DUX25 and DUXPWS)<br /><br>- Hyperphagia questionnaire (hyperphagia questionnaire Dykens)<br /><br>- Theory of Mind (TOM test)<br /><br>- Change in social and eating behaviour (diary)<br /><br>- fMRI (BOLD responses during a task with food pictures<br /><br>- Laboratory parameters (oxytocin in saliva and blood)<br /><br>- Safety parameters (laboratory parameters and medical assessments).</p><br>