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Trial registered on ANZCTR


Registration number
ACTRN12609000513213
Ethics application status
Approved
Date submitted
19/03/2009
Date registered
29/06/2009
Date last updated
6/11/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
A course of oxytocin nasal spray (OT) to treat social problems in youth with autism spectrum disorders
Scientific title
A double blind randomised controlled trial of oxytocin nasal spray to treat social problems in autistic youth
Secondary ID [1] 283527 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Autism Spectrum Disorders 4400 0
Condition category
Condition code
Mental Health 237212 237212 0 0
Autistic spectrum disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In a double blind, randomized controlled trial, young people with Autism Spectrum Disorders are randomly assigned to receive an 8-week course of oxytocin nasal spray (Syntocinon) or a placebo nasal spray. Participants or their carers administer the nasal spray twice daily (morning and night). Participants aged between 12 and 15 receive 18 international units at each administration. Participants aged between 16 and 18 receive 24 international units. Participants are assess before the trial commences, 4-weeks into the trial (midpoint), at treatment completion (8-weeks from commencement) and three months following treatment completion. At each assessment point participants complete a range of assessments, including experimental tests and self-report measures. Participants also complete diagnostic assessments pre-intervention and 3 months post trial completion.
Intervention code [1] 4132 0
Treatment: Drugs
Intervention code [2] 236821 0
Behaviour
Comparator / control treatment
Placebo matched nasal spray taken containing all ingredients except the active at the same frequency as the oxytocin nasal spray (twice per day for 8 weeks).
Control group
Placebo

Outcomes
Primary outcome [1] 5519 0
Social functionining (parent and teacher reports) as indicated by the Social Responsiveness Scale.
Timepoint [1] 5519 0
One week pre-treatment assessment, 4-weeks mid-treatment assessment, 8-week treatment completion, 3-months post treatment completion.
Secondary outcome [1] 9287 0
Eye-Gaze and Reading the Mind in the Eyes Test (RMET) assessed via self-report assessment and eye-tracking equipment
Timepoint [1] 9287 0
One week pre treatment assessment, 4-week mid-treatment assessment, 8-week treatment completion, 3-months post treatment completion
Secondary outcome [2] 9288 0
Self-Reports of Repetitive Behaviour including the Repeditive Behaviour Scalce
Timepoint [2] 9288 0
One week pre treatment assessment, 4-week mid-treatment assessment, 8-week treatment completion, 3-months post treatment completion
Secondary outcome [3] 9289 0
Diagnosis and Clinician Global Assessment as indicated by interview from Clinical Psychologists and Psychiatrists
Timepoint [3] 9289 0
One week pre treatment assessment, 8-week treatment completion, 3-months post treatment completion

Eligibility
Key inclusion criteria
Male youth with a primary diagnosis of Autism or Asperger disorder with a mental age of 8 or higher.
Minimum age
12 Years
Maximum age
18 Years
Gender
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Females, mental age below 8. 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. This code has been developed by an independent pharmaist.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2 / 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)
Recruitment postcode(s) [1] 1527 0
2050

Funding & Sponsors
Funding source category [1] 5026 0
Government body
Name [1] 5026 0
National Health and Medical Research Council
Address [1] 5026 0
Level 1, 16 Marcus Clarke Street
Canberra ACT 2601
Country [1] 5026 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
94 Mallett St Camperdown, Sydney, 2050
Country
Australia
Secondary sponsor category [1] 4129 0
None
Name [1] 4129 0
Address [1] 4129 0
Country [1] 4129 0
Other collaborator category [1] 586 0
University
Name [1] 586 0
Monash University
Address [1] 586 0
Faculty of Medicine, Nursing and Health Sciences
Monash University
Victoria 3800
Country [1] 586 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6627 0
University of Sydney Human Research Ethics Committee
Ethics committee address [1] 6627 0
Human Research Ethics Comittee, Level 6, Jane Foss Russell Building G02 The University of Sydney, Darlington, NSW 2006
Ethics committee country [1] 6627 0
Australia
Date submitted for ethics approval [1] 6627 0
01/01/2009
Approval date [1] 6627 0
23/03/2009
Ethics approval number [1] 6627 0

Summary
Brief summary
This study tests whether a course of oxytocin over 8-weeks improves the social communication problems in young people with autistic spectrum disorders. It is predicted that individuals from the community diagnosed with autism or asperger's disorder and within ADOS assessment criteria for autism who receive a course of oxytocin nasal spray will show improved social functioning on self-report, diagnostic and experimental measures, in comparison to participants assigned to placebo admistration. Two single session assessment administered participants. All participants, therapists, assessors, and data entry staff are blind to condition.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29334 0
A/Prof Adam Guastella
Address 29334 0
94 Mallett St Brain & Mind Research Institute, University of Sydney, Camperdown, NSW 2050
Country 29334 0
Australia
Phone 29334 0
+61 2 9351 0539
Fax 29334 0
Email 29334 0
adam.guastella@sydney.edu.au
Contact person for public queries
Name 12581 0
A/Prof Adam Guastella
Address 12581 0
94 Mallett St
Brain & Mind Research Institute,
University of Sydney, Camperdown, 2050
Country 12581 0
Australia
Phone 12581 0
+61 2 9351 0539
Fax 12581 0
+61 2 9351 0881
Email 12581 0
adam.guastella@sydney.edu.au
Contact person for scientific queries
Name 3509 0
A/Prof Adam Guastella
Address 3509 0
94 Mallett St Brain & Mind Research Institute, University of Sydney, Camperdown, NSW 2050
Country 3509 0
Australia
Phone 3509 0
+61 2 9351 0539
Fax 3509 0
+61 2 9351 0881
Email 3509 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