Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000776505
Ethics application status
Approved
Date submitted
13/07/2015
Date registered
27/07/2015
Date last updated
27/07/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of oxytocin on body perception in healthy volunteers
Scientific title
Effects of oxytocin on body perception in healthy volunteers
Secondary ID [1] 286926 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Body perception 295349 0
Condition category
Condition code
Mental Health 295618 295618 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study will employ a double-blind placebo controlled within-subjects design. Each participant will complete two treatment conditions, separated by a minimum of one week. The treatment conditions will involve a single dose of either placebo or oxytocin (24 IU of Syntocinon spray), delivered by intranasal spray. Participants will receive each treatment in the laboratory, supervised by an experimenter.
Intervention code [1] 292117 0
Treatment: Drugs
Comparator / control treatment
The control condition will consist of an intranasal placebo spray. The placebo spray consists of 5 ml Sorbitol, Glycerin and preserved water containing parabens.
Control group
Placebo

Outcomes
Primary outcome [1] 295332 0
Body perception will be examined via the experience of a multi-sensory perceptual illusion, as assessed by self-report ratings, proprioceptive estimates, and kinematic measures. Self-report ratings are assessed on a 20 cm visual analogue scale. Proprioceptive estimates are assessed by recording the felt position of the arm in the horizontal/lateral plane directly before and after the experience of the illusion. Specifically, participants indicate the felt position of their arm with the use of a marker that can be slide across a bar positioned above a box in which their arm is hidden; the marker position is recorded to the nearest mm with a ruler. Kinematic measures relate to a grasping movement recorded with an electromagnetic tracker, and include integrated jerk and modelled sub-movement parameters.
Timepoint [1] 295332 0
The study will consist of two testing sessions – oxytocin and placebo – separated by a minimum of one week. Experience of the illusion will be assessed 45 minutes after each intervention is delivered, and compared between the two sessions.
Secondary outcome [1] 315370 0
Autism spectrum traits in the sample of healthy volunteers will be assessed using the Autism Spectrum Quotient. The effect of oxytocin on the experience of the illusion will be assessed in relation to these traits.
Timepoint [1] 315370 0
Autism spectrum traits will be assessed only once, directly before delivery of the first intervention (whether placebo or oxytocin).

Eligibility
Key inclusion criteria
Healthy male adults.
Minimum age
18 Years
Maximum age
55 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Individuals who meet the following criteria will be excluded from participating in this study:
- Current depression or psychosis.
- A personal or family history of a diagnosis of any neurological/psychiatric disorders
- Currently on medication known to have an impact on mood or cognitive performance (e.g., antidepressants, anxiolytics, etc)
- A history of substance abuse or head injury
- Current smokers
- Have an artificial cardiac pacemaker.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
This study involves a single sample of healthy volunteers. A repeated measures design will be used to compare the effects of oxytocin to placebo. Hence, all participants will complete both the treatment (oxytocin) and control (placebo) conditions. The order that participants complete these conditions will be counterbalanced, and the treatment received in each session will be double-blinded.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
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
Intervention assignment
Crossover
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
10/08/2015
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 291494 0
Government body
Name [1] 291494 0
Australian Research Council
Country [1] 291494 0
Australia
Funding source category [2] 291495 0
University
Name [2] 291495 0
Monash University
Country [2] 291495 0
Australia
Primary sponsor type
Individual
Name
Professor Jakob Hohwy
Address
20 Chancellors Walk
Monash University
Clayton campus
Wellington Road
Clayton
Victoria 3800
Australia
Country
Australia
Secondary sponsor category [1] 290173 0
None
Name [1] 290173 0
Address [1] 290173 0
Country [1] 290173 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293036 0
Monash University Human Research Ethics Committee (MUHREC)
Ethics committee address [1] 293036 0
Ethics committee country [1] 293036 0
Australia
Date submitted for ethics approval [1] 293036 0
Approval date [1] 293036 0
01/07/2015
Ethics approval number [1] 293036 0
CF15/2291 - 2015000925

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 58150 0
Prof Jakob Hohwy
Address 58150 0
20 Chancellors Walk
Monash University
Clayton campus
Wellington Road
Clayton
Victoria 3800
Australia
Country 58150 0
Australia
Phone 58150 0
+61 3 99053208
Fax 58150 0
Email 58150 0
[email protected]
Contact person for public queries
Name 58151 0
Jakob Hohwy
Address 58151 0
20 Chancellors Walk
Monash University
Clayton campus
Wellington Road
Clayton
Victoria 3800
Australia
Country 58151 0
Australia
Phone 58151 0
+61 3 99053208
Fax 58151 0
Email 58151 0
[email protected]
Contact person for scientific queries
Name 58152 0
Jakob Hohwy
Address 58152 0
20 Chancellors Walk
Monash University
Clayton campus
Wellington Road
Clayton
Victoria 3800
Australia
Country 58152 0
Australia
Phone 58152 0
+61 3 99053208
Fax 58152 0
Email 58152 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.