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Trial registered on ANZCTR


Registration number
ACTRN12614000991617
Ethics application status
Not yet submitted
Date submitted
8/09/2014
Date registered
15/09/2014
Date last updated
15/09/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
An investigation of the effects of intranasal oxytocin spray on socio-emotional brain regions in participants with Body Dysmorphic Disorder.
Scientific title
An investigation of the effects of intranasal oxytocin spray on socio-emotional brain regions in participants with Body Dysmorphic Disorder.
Secondary ID [1] 285225 0
Nil
Universal Trial Number (UTN)
U1111-1160-8784
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Body Dysmorphic Disorder 292854 0
Condition category
Condition code
Mental Health 293155 293155 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Two acute treatment (24 IU each) conditions including; a) intranasal placebo, and b) intranasal oxytocin (Syntocinon, Novartis, Switzerland). The two treatment conditions will be separated by a minimum of 1 week (washout period). The nasal sprays will be administered 50 mins prior to the functional magnetic resonance (fMRI) protocol. The fMRI protocol will be one hour in duration and involve showing participants a brief task involving pictures of human faces expressing different emotions. The fMRI protocol will also involve taking structural, resting state and diffusion tensor imaging (DTI) images of the brain while the participant is not engaged in a task.
Intervention code [1] 290101 0
Treatment: Drugs
Comparator / control treatment
Placebo, a saline solution without the active (peptide) ingredient.
Healthy controls will be used in comparisons to the Body Dysmorphic Disorder (BDD) patients.
Control group
Placebo

Outcomes
Primary outcome [1] 293013 0
Functional MRI (fMRI) data will be collected in response to an emotional face expression task. The fMRI data will be compared within the patient (Body Dysmorphic Disorder) group for differences in brain response (e.g., in the amygdala) between placebo and oxytocin conditions.
Timepoint [1] 293013 0
The data will be collected in the 50-80 min post drug administration and will be analysed post all data collection.
Secondary outcome [1] 310145 0
Using the fMRI data, the patients with BDD will be compared to healthy controls on brain response (e.g., amygdala) under normal (placebo) conditions to see whether any differences in brain activity is present.

Using the DTI and structural MRI data, the whole-brain and white matter structure of the brains of patients with BDD will be examined in comparison to the healthy control group to see if any structural or white matter differences are present.
Timepoint [1] 310145 0
The data will be collected in the 50-80 min post drug administration and will be analysed post all data collection.

Eligibility
Key inclusion criteria
For Healthy controls: Right-handed; between the ages of 18-65 years; non-smoker and no drug/alcohol abuse; medication free; no neurological disorders, and no metal objects present in body (or which can't be removed or which is not MRI safe). Women who have not experienced menopause.
For Body Dysmorphic Disorder (BDD): As above plus a diagnosis of the disorder is required.
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Clinically significant medical or neurological condition (other than BDD for the patients), significant head injury (or loss of consciousness from longer than 5 mins), presence of ferrous-containing metals within the body, inability to tolerate small enclosed spaces without anxiety.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
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)
VIC

Funding & Sponsors
Funding source category [1] 289920 0
University
Name [1] 289920 0
Prof Susan Rossell's Research Initiative Scheme within the Faculty of Health, Arts and Design, Swinburne University of Technology, Melbourne, Australia.
Address [1] 289920 0
PO Box 218
Hawthorn VIC 3122
Country [1] 289920 0
Australia
Primary sponsor type
Individual
Name
Prof Susan Rossell
Address
PO Box 218
Swinburne University of Technology
Hawthorn VIC 3122
Country
Australia
Secondary sponsor category [1] 288610 0
None
Name [1] 288610 0
Address [1] 288610 0
Country [1] 288610 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 291569 0
St Vincent's Hospital Melbourne (SVHM)
Ethics committee address [1] 291569 0
41 Victoria Parade
Fitzroy
VIC 3065
Ethics committee country [1] 291569 0
Australia
Date submitted for ethics approval [1] 291569 0
28/07/2014
Approval date [1] 291569 0
Ethics approval number [1] 291569 0
HREC-D 089/14

Summary
Brief summary
The overall aim of the current study is to examine the brain correlates of emotion recognition in patients with Body Dysmorphic Disorder using a double-blind placebo controlled intranasal oxytocin design and two MRI techniques involving fMRI and diffusion tensor imaging (DTI).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 50942 0
Prof Susan Rossell
Address 50942 0
PO Box 218
Brain and Psychological Sciences Research Institute (BPsyC)
Swinburne University of Technology
Hawthorn VIC 3122
Country 50942 0
Australia
Phone 50942 0
+61 3 9214 8173
Fax 50942 0
Email 50942 0
SRossell@SRossell.com
Contact person for public queries
Name 50943 0
Miss Sally Grace
Address 50943 0
400B Burwood Road, Level 2
Swinburne University of Technology
Hawthorn VIC 3122
Country 50943 0
Australia
Phone 50943 0
+61392148415
Fax 50943 0
Email 50943 0
sgrace@swin.edu.au
Contact person for scientific queries
Name 50944 0
Miss Sally Grace
Address 50944 0
400B Burwood Road, Level 2
Swinburne University of Technology
Hawthorn VIC 3122
Country 50944 0
Australia
Phone 50944 0
+61392148415
Fax 50944 0
Email 50944 0
sgrace@swin.edu.au

No data has been provided for results reporting
Summary results
Not applicable