An investigation of the effects of intranasal oxytocin spray on socio-emotional brain regions in participants with Body Dysmorphic Disorder.

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12614000991617
• Date of registration: 15/09/2014
• Prospective Registration: Yes
• Primary sponsor: Prof Susan Rossell
• 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.
• Date of first enrolment: 01/11/2014
• Target sample size: 64
• Recruitment status: Not yet recruiting
• URL: https://anzctr.org.au/ACTRN12614000991617.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Randomised controlled trial;

Countries of recruitment

Australia

Contacts

• Name: Miss Sally Grace

• Name: Miss Sally Grace

Key inclusion & exclusion criteria

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.
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.

Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Body Dysmorphic Disorder;
Body Dysmorphic Disorder

Mental Health - Anxiety

Intervention(s)

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.

Primary Outcome(s)

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

Secondary Outcome(s)

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

Secondary ID(s)

Nil

Source(s) of Monetary Support

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

Ethics review

Status: Not approved
Approval date:
Contact:

St Vincent's Hospital Melbourne (SVHM)