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Trial registered on ANZCTR


Registration number
ACTRN12611000061932
Ethics application status
Approved
Date submitted
2/12/2010
Date registered
17/01/2011
Date last updated
4/11/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects of Oxytocin on Social Behavior and Repetitive Behavior in Children with Autism.
Scientific title
A Course of Oxytocin To Improve Social Interaction and Repetitive Behaviors In Children With Autism Spectrum Disorders.
Secondary ID [1] 253227 0
Nil
Universal Trial Number (UTN)
U1111-1118-3796
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Autism Spectrum Disorders. 258761 0
Condition category
Condition code
Mental Health 258907 258907 0 0
Autistic spectrum disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Oxytocin nasal spray.
Duration: 5 week treatment. First week, the dose will start at 3 International Units (IU) and increase by 3IU every 2 days. From the 7th day onwards, participants will receive 12IU for the remaining 4 weeks. The nasal spray will be delivered everyday, morning and night, one spray per nostril
This is a crossover study, so after the first course of treatment, participants will have a 4 week washout period and then commence the alternative treatment. The alternative treatment will follow the same dose escalation procedure as the first course of treatment.
Intervention code [1] 257696 0
Treatment: Drugs
Intervention code [2] 257870 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 5 weeks).
Control group
Placebo

Outcomes
Primary outcome [1] 259763 0
Positive social interaction as indexed by observational tasks, parent and teacher questionnaires and a coding protocol to tally the frequency of social behaviors during observational assessments and home therapy sessions.
Timepoint [1] 259763 0
Four; pre and post for spray 1 and pre and post for spray 2
Primary outcome [2] 259765 0
Severity of repetitive behavior will be measured using the caregiver/guardian and teacher repetitive behavior scale- revised. in addition, a coding protocol will be used to tally the frequency of specific repetitive behaviors during observational assessments and home therapy sessions.
Timepoint [2] 259765 0
Four; pre and post for spray 1 and pre and post for spray 2
Secondary outcome [1] 268530 0
Eye gaze to dynamic human faces portrayed on a computer screen. Eye tracking equipment will record the duration and frequency of fixations to facial features during a video scene.
Timepoint [1] 268530 0
Four; pre and post for spray 1 and pre and post for spray 2
Secondary outcome [2] 268531 0
General improvement as indicated by the clinical Global Impressions score
Timepoint [2] 268531 0
Four; pre and post for spray 1 and pre and post for spray 2
Secondary outcome [3] 268878 0
Level of executive functioning measured with four behavioral tasks.
Timepoint [3] 268878 0
Four; pre and post for spray 1 and pre and post for spray 2
Secondary outcome [4] 268879 0
Preferential attention to social stimuli will be assessed using a visual exploration task and eye tracking equipment.
Timepoint [4] 268879 0
Four; pre and post for spray 1 and pre and post for spray 2
Secondary outcome [5] 268882 0
Behavioral and emotional problems as assessed by the Developmental Behavior Checklist (DBC)
Timepoint [5] 268882 0
Four; pre and post for spray 1 and pre and post for spray 2
Secondary outcome [6] 268883 0
Quality of social interactions as indexed by the quality of social behavior scale (therapist and teacher reports)
Timepoint [6] 268883 0
reports to be filled out each week for 4 weeks prior to each treatment, then each week the participant is on the full dose of nasal spray (4 weeks).

Eligibility
Key inclusion criteria
Meet DSM-IV-TR criteria for ASD
Minimum age
3 Years
Maximum age
8 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Not sensitive to preservatives (in particular E 216, E 218, and chlorobutanol hemihydrate)

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)
enrolling: A flyer advertising the study will be emailed to parents of children who attend the Lizards Children’s centre. Potential participants will be referred to the Brain & Mind Research Institute, The University of Sydney for a medical interview to determine eligibility for the active medication and a diagnostic assessment to confirm autism diagnosis. Caregivers of the participants will provide written informed consent before the assessment begins.

Participants will be randomly allocated either oxytocin or placebo during phase 1 treatment. Then the alternative treatment during phase 2. Each participant is assigned a prepacked numbered container containing either oxytocin or placebo according to the randomization schedule developed by the compounding chemist
randomized allocation:
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random number generation using computer software. Each number is labeled with 'a' or 'b' where a or b could represent either oxytocin or placebo. This code has been developed by an independent pharmacist.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 2
Type of endpoint(s)
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] 258169 0
Self funded/Unfunded
Name [1] 258169 0
Address [1] 258169 0
Country [1] 258169 0
Primary sponsor type
University
Name
University of Sydney
Address
The University of Sydney
Sydney
NSW 2006
Country
Australia
Secondary sponsor category [1] 257343 0
None
Name [1] 257343 0
Address [1] 257343 0
Country [1] 257343 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260156 0
University of Sydney Human ethics committee
Ethics committee address [1] 260156 0
Level 6
Jane Foss Russell Building G02
The University of Sydney NSW 2006
Ethics committee country [1] 260156 0
Australia
Date submitted for ethics approval [1] 260156 0
06/07/2010
Approval date [1] 260156 0
21/09/2010
Ethics approval number [1] 260156 0
12261

Summary
Brief summary
Oxytocin is a natural hormone which plays a critical role in social behavior such as bonding, cooperativeness, trust, emotion recognition and face processing. Autism is a developmental disorder characterized by profound impairments in social behavior, communication and presence of repetitive behaviors. This study aims to assess the efficacy of oxytocin treatment in ameliorating social impairments in young children with autism. In particular, we aim to assess whether oxytocin treatment can improve the capacity for social interaction, face processing and reduce the occurrence of repetitive behaviors.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31982 0
A/Prof Adam Guastella
Address 31982 0
Brain and Mind Research Institute, University of Sydney
94 mallett street Camperdown, NSW, 2050
Country 31982 0
Australia
Phone 31982 0
+61 293510539
Fax 31982 0
Email 31982 0
Adam.Guastella@Sydney.edu.au
Contact person for public queries
Name 15229 0
Miss Chathuri (CJ) Yatawara
Address 15229 0
100 Mallett st,
Brain & Mind Research Institute,
University of Sydney,
Camperdown, NSW, 2050
Country 15229 0
Australia
Phone 15229 0
+61 2 9114 4106
Fax 15229 0
Email 15229 0
chathuri.yatawara@sydney.edu.au
Contact person for scientific queries
Name 6157 0
A/Prof Adam Guastella
Address 6157 0
94 Mallett St
Brain & Mind Research Institute,
University of Sydney, Camperdown, NSW, 2050
Country 6157 0
Australia
Phone 6157 0
+61 2 9351 0539
Fax 6157 0
+61 2 9351 0881
Email 6157 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