Effects of Intranasal Administration of Oxytocin in Adults With Prader-Willi Syndrome
Overview
- Phase
- Phase 2
- Intervention
- Placebo continuous
- Conditions
- Prader-Willi Syndrome
- Sponsor
- University Hospital, Toulouse
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Change in Behaviour as assessed by score variations in specific questionaries
- Status
- Completed
- Last Updated
- 4 months ago
Overview
Brief Summary
The investigator thinks that the oxytocin (OT) can improve durably and significantly the behavior disorders and thus the socialization but also the satisfaction and could thus be an interesting therapeutic alternative for the patients presenting a Prader-Willi Syndrome (SPW). Although today several studies demonstrated the effects of the OT in various domains of the behavior, the investigator do not know either its specificity of action about the cerebral level, or its duration of action, or the optimal modalities of administration and in particular at patients SPW.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Prader-Willi syndrome genetically confirmed
- •Absence of extension of the QT interval in the electrocardiogram
- •Absence of hypokalemia
Exclusion Criteria
- •Psychiatric troubles
- •Anomalies of the heart rhythm in significant ECG
- •Hepatic insufficiency
- •Renal insufficiency
- •Patients presenting a pregnancy or breast-feeding
- •High sensibility to OT
- •High sensibility to the excipients of the product
- •Patients having family history of genetic pathology causing an extension of the interval QT
- •Patients having risk factors of advanced twist
Arms & Interventions
placebo daily
daily administration of placebo during 28 days : placebo continuous
Intervention: Placebo continuous
24 IU of oxytocin daily
24 IU of daily oxytocin administration during 28 days : oxytocin continuous
Intervention: Oxytocin (OXT) continuous
24 IU of oxytocin every 3 days
24 IU of daily oxytocin every 3 days and placebo the following 2 days after each oxytocin administration during 28 days
Intervention: Placebo
24 IU of oxytocin every 3 days
24 IU of daily oxytocin every 3 days and placebo the following 2 days after each oxytocin administration during 28 days
Intervention: Oxytocin
Outcomes
Primary Outcomes
Change in Behaviour as assessed by score variations in specific questionaries
Time Frame: Every day before and after administration of treatment during 28 days
Change in eating Behaviour as assessed by score variations in specific questionaries
Time Frame: Every day before and after administration of treatment during 28 days
Secondary Outcomes
- Change in eating behaviour as assessed by score variations in hunger visual analogic scale(Every day before and after administration of treatment during 28 days)
- Cerebral Metabolism variations as assessed by Positron Emission Tomography (PET-scan)(Day 1, day 2 and day 30)
- Evaluation of social skills assessed by specific questionnaires(Day 1, day 2 and day 30)
- Social processing assessed by oculomotor exploration(Day 1, day 2 and day 30)
- Multisensory processing assessed by Neurovisual task(Day 1, day 2 and day 30)
- Hormon blood concentration levels as assessed by bioassays(Day 2 and day 30)
- Cerebral Metabolism variations as assessed by functional Magnetic Resonance Imaging (f-RMI)(Day 1, day 2 and day 29)
- Evaluation of executive function assessed by specific questionnaires(Day 1, day 2 and day 30)
- Evaluation of theory of mind assessed by specific questionnaires(Day 1, day 2 and day 30)