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Trial registered on ANZCTR


Registration number
ACTRN12609000982213
Ethics application status
Approved
Date submitted
11/11/2009
Date registered
13/11/2009
Date last updated
2/01/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Oxytocin treatment for Prader Willi Syndrome
Scientific title
A double blind randomised controlled, cross over design trial to evaluate the effect of oxytocin nasal spray on eating behaviour, tantrums/rage and weight in people with Prader Willi Syndrome
Secondary ID [1] 262782 0
x
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prader Willi Syndrome 252102 0
Condition category
Condition code
Human Genetics and Inherited Disorders 252308 252308 0 0
Other human genetics and inherited disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 241488 0
Treatment: Drugs
Comparator / control treatment
The placebo nasal spray is a solution containing all of the ingredients used in the oxytocin nasal spray except the active oxytocin. The placebo is administered in exactly the same manner as the oxytocin spray.
Control group
Placebo

Outcomes
Primary outcome [1] 253177 0
Eating behaviours (hyperphagia and pica) as measured by the Developmental Behaviour Checklist - Monitoring Chart (DBC-M)
Timepoint [1] 253177 0
Daily during each of the 8 week trial periods of the oxytocin or nasal sprays.
Primary outcome [2] 253188 0
Rages/tantrums as measured by the Developmental Behaviour Checklist - Monitoring Chart (DBC-M)
Timepoint [2] 253188 0
Daily during each of the 8 week trial periods of the oxytocin or nasal sprays.
Primary outcome [3] 253189 0
Weight
Timepoint [3] 253189 0
Baseline at week 1
Weekly at home
Baseline at week 11
Weekly at home
End of week 18
Secondary outcome [1] 262123 0
Social cognition as measured by the Reading the Eyes in the Mind Test (RMET)
Timepoint [1] 262123 0
Week 1 - day 1 of first (oxytocin or placebo) nasal spray
Week 11 - day 1 of second (oxytocin or placebo) nasal spray
Secondary outcome [2] 262124 0
Overall behaviour and emotional problems as measured by the Developmental Behaviour Checklist - Parent/Carer version (DBC-P) for participants 18 years and younger, or Developmental Behaviour Checklist - Adult version (DBC-A)for participants over 18years, and the Developmental Behaviour Checklist - Teacher version (DBC-T), Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
Timepoint [2] 262124 0
DBC-P - baseline week 1 day 1 and end of week 8; baseline week 11 day 1 and end of week 18.
DBC-T - baseline week 1 and end of week 8; baseline week 11 and end of week 18.
Y-BOCS - baseline week 1, day 1, week 11 day 1; end of week 18.
Secondary outcome [3] 262125 0
Somnolence as measured by the Epworth Sleepiness Scale (ESS).
Timepoint [3] 262125 0
ESS- - baseline week 1, day 1, week 11 day 1; end of week 18.
Secondary outcome [4] 279487 0
The Hyperphagia Questionnaire
Timepoint [4] 279487 0
Baseline week 1, day 1; week 11, day 1; end of week 18.
Secondary outcome [5] 279488 0
The Wechsler Abbreviated Scale of Intelligence WASI.
Timepoint [5] 279488 0
Once at week 1, day 1
Secondary outcome [6] 279489 0
The Movie Stills Task
Timepoint [6] 279489 0
Week 1, day 1 and week 11, day 1

Eligibility
Key inclusion criteria
Genetically proven diagnosis of Prader Willi Syndrome
Mental age above 10 years
Minimum age
12 Years
Maximum age
30 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Drug allocation concealment is conducted by numbering all containers.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random number generation using computer software. Each number is labelled with 'a' or 'b' where a or b could represent either Oxytocin or Placebo in a cross-over design. This code has been developed by an independent pharmacist.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
All participants, assessors, therapists, and data entry staff are blind to drug condition.
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/02/2010
Actual
23/03/2010
Date of last participant enrolment
Anticipated
Actual
3/08/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 243967 0
Government body
Name [1] 243967 0
National Health and Medical Research Council
Country [1] 243967 0
Australia
Funding source category [2] 243968 0
Charities/Societies/Foundations
Name [2] 243968 0
St George Foundation
Country [2] 243968 0
Australia
Funding source category [3] 243972 0
Charities/Societies/Foundations
Name [3] 243972 0
Foundation for Prader Willi Research
Country [3] 243972 0
United States of America
Primary sponsor type
University
Name
University of Sydney
Address
Brain & Mind Research Institute (BMRI)
94 Mallett St
Camperdown NSW 2050
Country
Australia
Secondary sponsor category [1] 251321 0
None
Name [1] 251321 0
Address [1] 251321 0
Country [1] 251321 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 244082 0
University of Sydney
Ethics committee address [1] 244082 0
Human Ethics Administration
Level 6, Jane Foss Russell Building - G02
Darlington Campus
The University of Sydney NSW 2006
Ethics committee country [1] 244082 0
Australia
Date submitted for ethics approval [1] 244082 0
Approval date [1] 244082 0
Ethics approval number [1] 244082 0

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30449 0
Prof Professor Stewart Einfeld
Address 30449 0
BMRI
94 Mallett St
Camperdown
NSW 2050
Australia
Country 30449 0
Australia
Phone 30449 0
+61 2 9351 0884
Fax 30449 0
Email 30449 0
[email protected]
Contact person for public queries
Name 13696 0
Prof Stewart Einfeld
Address 13696 0
BMRI
94 Mallett St
Camperdown NSW 2050
Country 13696 0
Australia
Phone 13696 0
+61 2 9351 0884
Fax 13696 0
Email 13696 0
[email protected]
Contact person for scientific queries
Name 4624 0
Prof Stewart Einfeld
Address 4624 0
BMRI
94 Mallett St
Camperdown NSW 2050
Country 4624 0
Australia
Phone 4624 0
+61 2 9351 0884
Fax 4624 0
Email 4624 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseOxytocin system dysfunction as a common mechanism underlying metabolic syndrome and psychiatric symptoms in schizophrenia and bipolar disorders.2017https://dx.doi.org/10.1016/j.yfrne.2016.12.004
N.B. These documents automatically identified may not have been verified by the study sponsor.