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Trial registered on ANZCTR


Registration number
ACTRN12609000368235
Ethics application status
Approved
Date submitted
18/11/2008
Date registered
27/05/2009
Date last updated
6/11/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of Oxytocin (OT) on social cognition and behaviour in youth with Autism Spectrum Disorders (ASD).
Scientific title
THe effects of Oxytocin in young people with Autism to treat social communication problems
Secondary ID [1] 754 0
Therapeutic Goods Association Clinical Trial Notification (TGA CTN): 2008/596
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Autism 3993 0
Condition category
Condition code
Mental Health 4192 4192 0 0
Autistic spectrum disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Young people with Autism Spectrum Disorders are given a single dose of oxytocin nasal spray or an identical placebo in a crossover design with a one-week washout period. For children between the age of 12 and 15 we use a 18 International Unit dose, while people between the age of 16 and 20 receive a 24 International Unit dose. Participants receive the nasal spray, wait 45 minutes and complete experimental tasks. Participants return one week later to receive the nasal spray again, wait 45 minutes and complete the same experimental tasks. On both occasions participants are observed for a period of 1.5 hours while they complete social cognition tasks. These tasks include emotion recognition (Reading the mind in the eyes) as well as eye-tracking when viewing human faces. The entire trial is completed within these two experimental testing sessions.
Intervention code [1] 3718 0
Treatment: Drugs
Comparator / control treatment
The placebo nasal spray is a solution containing all of the ingredients used in the OT nasal spray except the active OT. It is administered 45 minutes before participants complete experimental cognition tasks. The placebo is administered once in exactly the same manner as the OT spray. Participants receive 18IU for 12 - 15 year olds and 24 IU for 16 to 20 year olds.
Control group
Placebo

Outcomes
Primary outcome [1] 5086 0
Performance on emotion recognition (Reading the mind in the eyes test)
Timepoint [1] 5086 0
Assessed 45 minutes post nasal spray administration.
Secondary outcome [1] 8542 0
Side effect reports noted from participants
Timepoint [1] 8542 0
Assessed 45 minutes post nasal spray administration.

Eligibility
Key inclusion criteria
Male youth with a primary diagnosis of Autism or Asperger disorder with a mental age of 12 or higher.
Minimum age
12 Years
Maximum age
20 Years
Gender
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Females, mental age below 12. Chronological age below 12.

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.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
All subjects, assessors, therapists, and data entry staff are blind to drug condition
Phase
Phase 3
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4576 0
Government body
Name [1] 4576 0
National Health and Medical Research Council
Address [1] 4576 0
GPO Box 1421
Canberra ACT 2601
Country [1] 4576 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
94 Mallett St
Camperdown, Sydney, NSW, 2050
Country
Australia
Secondary sponsor category [1] 3759 0
None
Name [1] 3759 0
Address [1] 3759 0
Country [1] 3759 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6239 0
University of Sydney Human Research Ethics Committee
Ethics committee address [1] 6239 0
Human Research Ethics Comittee,
Level 6, Jane Foss Russell Building G02
The University of Sydney, Darlington, NSW, 2006
Ethics committee country [1] 6239 0
Australia
Date submitted for ethics approval [1] 6239 0
01/02/2008
Approval date [1] 6239 0
14/05/2008
Ethics approval number [1] 6239 0
10755

Summary
Brief summary
This study tests whether Oxytocin improves the social communication problems in young people with Autism. It is predicted that individuals from the community diagnosed with autism or asperger's disorder who receive a single dose of oxytocin nasal spray will show improved performance on social cognition tests in comparison to performance on these tests under a placebo. Two single session assessment sessions within a two week period are conducted using a crossover design. All subjects, therapists, assessors, and data entry staff are blind to condition.
Trial website
None
Trial related presentations / publications
Published Manuscript:

Guastella, A.J., Einfeld, S.E., Gray, K., Rinehart, N., Tonge, B., Lambert, T., & Hickie, I.B. (2010). Oxytocin improves emotion recognition for youth with Autism. Biological Psychiatry, 67(7):692-4.
Public notes

Contacts
Principal investigator
Name 29142 0
A/Prof Adam Guastella
Address 29142 0
Brain & Mind Research Institute, University of Sydney, 94 Mallett St, Camperdown, NSW, 2050
Country 29142 0
Australia
Phone 29142 0
+61 2 9351 0539
Fax 29142 0
Email 29142 0
adam.guastella@sydney.edu.au
Contact person for public queries
Name 12299 0
A/Prof Adam Guastella
Address 12299 0
Brain & Mind Research Institute,
University of Sydney, 94 Mallett St, Camperdown, NSW, 2050
Country 12299 0
Australia
Phone 12299 0
+61 2 9351 0539
Fax 12299 0
+61 2 9351 0881
Email 12299 0
adam.guastella@sydney.edu.au
Contact person for scientific queries
Name 3227 0
A/Prof Adam Guastella
Address 3227 0
Brain & Mind Research Institute,
University of Sydney, 94 Mallett St, Camperdown, NSW, 2050
Country 3227 0
Australia
Phone 3227 0
+61 2 9351 0539
Fax 3227 0
+61 2 9351 0881
Email 3227 0
adam.guastella@sydney.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary