Trial Review

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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
Sex
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
1/12/2010
Actual
2/12/2010
Date of last participant enrolment
Anticipated
Actual
10/11/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
40
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
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
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
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
[email protected]
Contact person for public queries
Name 15229 0
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
[email protected]
Contact person for scientific queries
Name 6157 0
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
[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
No additional documents have been identified.