ANZCTR - Registration

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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]

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

Condition category

Condition code

Mental Health

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]

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]

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]

The data will be collected in the 50-80 min post drug administration and will be analysed post all data collection.

Secondary outcome [1]

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]

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

Sex

Both males and females

Can healthy volunteers participate?

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

1/11/2014

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]

University

Name [1]

Prof Susan Rossell's Research Initiative Scheme within the Faculty of Health, Arts and Design, Swinburne University of Technology, Melbourne, Australia.

Address [1]

PO Box 218
Hawthorn VIC 3122

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Not yet submitted

Ethics committee name [1]

St Vincent's Hospital Melbourne (SVHM)

Ethics committee address [1]

41 Victoria Parade 
Fitzroy
VIC 3065

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

28/07/2014

Approval date [1]

Ethics approval number [1]

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

Prof Susan Rossell

Address

PO Box 218
Brain and Psychological Sciences Research Institute (BPsyC)
Swinburne University of Technology
Hawthorn VIC 3122

Country

Australia

Phone

+61 3 9214 8173

Fax

[email protected]

Contact person for public queries

Name

Sally Grace

Address

400B Burwood Road, Level 2
Swinburne University of Technology
Hawthorn VIC 3122

Country

Australia

Phone

+61392148415

Fax

[email protected]

Contact person for scientific queries

Name

Sally Grace

Address

400B Burwood Road, Level 2
Swinburne University of Technology
Hawthorn VIC 3122

Country

Australia

Phone

+61392148415

Fax

[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

Type	Is Peer Reviewed?	DOI	Citations or Other Details	Attachment
Plain language summary	No		We completed a randomized, double-blind placebo-co... [More Details]
Study results article	Yes		Grace, S. A., Labuschagne, I., Castle, D. J., & Ro... [More Details]

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Intranasal oxytocin alters amygdala-temporal resting-state functional connectivity in body dysmorphic disorder: A double-blind placebo-controlled randomized trial.	2019	https://dx.doi.org/10.1016/j.psyneuen.2019.05.022

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically