None listed
Conditions
Brief summary
Prader-Willi Syndrome (PWS) is characterised by symptoms such as obsessions, overeating, rage attacks, skin picking, irregular sleep breathing and temperature control, and impairments in learning and understanding social cues. Evidence from brain studies suggest that such symptoms maybe related to a deficiency of oxytocin, a natural occurring hormone derived in the hypothalamus. This study aims to investigate the efficacy of oxytocin nasal spray on improving behaviour and physical health in PWS.
Interventions
In a double blind, randomised, controlled cross-over trial, young people with Prader Willi Syndrome will be randomly assigned to receive either an eight week course of oxytocin (Syntocinon) or placebo nasal spray, which will be followed by a two week wash out period. After the wash out period, participants will then receive the alternate version of the nasal spray, which will be administered for a further eight week period. The order of first nasal spray administration (either oxytocin or placeb
In a double blind, randomised, controlled cross-over trial, young people with Prader Willi Syndrome will be randomly assigned to receive either an eight week course of oxytocin (Syntocinon) or placebo nasal spray, which will be followed by a two week wash out period. After the wash out period, participants will then receive the alternate version of the nasal spray, which will be administered for a further eight week period. The order of first nasal spray administration (either oxytocin or placebo first) will be randomised across participants according to codes held by the compounding chemist. Participants 16 years and over will receive a dose of 40International Units and participants under 16 years will receive a dose of 32 International Units.
Sponsors
University of Sydney
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
12 Years to 30 Years
Healthy volunteers
No
Inclusion criteria
Genetically proven diagnosis of Prader Willi Syndrome Mental age above 10 years
Exclusion criteria
- Persons below 12 years -Persons with a mental age below 10 years - Persons without genetically proven diagnosis of Prader Willi Syndrome - Persons hypersensitive to the preservatives in the nasal spray, viz E216, E218 and chlorobutanol will be excluded.
Outcome results
None listed