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Trial registered on ANZCTR


Registration number
ACTRN12622000429752p
Ethics application status
Submitted, not yet approved
Date submitted
4/02/2022
Date registered
16/03/2022
Date last updated
16/03/2022
Date data sharing statement initially provided
16/03/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Using oxytocin in individuals with body dysmorphic disorder (BDD)
Scientific title
The effect of using oxytocin in individuals with body dysmorphic disorder (BDD)
Secondary ID [1] 306329 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Body Dysmorphic Disorder 325117 0
Condition category
Condition code
Mental Health 322529 322529 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Oxytocin, 0.6ml (24IU), once daily, as a nasal spray, for six weeks.
Adherence will be checked during weekly phone calls and by way of medication return at each visit.
Intervention code [1] 322763 0
Treatment: Drugs
Comparator / control treatment
placebo, 0.6ml (24IU), once daily, as a nasal spray, for six weeks.
Contains: Preserved Water, Methyl Paraben, Propyl Paraben and Glycerine
Weekly phone calls and examinations of returned drug will allow us to monitor adherence
Control group
Placebo

Outcomes
Primary outcome [1] 330320 0
BDD symptom severity on the BDD-Yale Brown Obsessive Compulsive Scale (YBOCS)
Timepoint [1] 330320 0
6 weeks post intervention commencement
Secondary outcome [1] 405815 0
The social cognition measure: The Hinting Task (Corcoran, Mercer & Frith, 1995)
Timepoint [1] 405815 0
6 weeks post intervention commencement
Secondary outcome [2] 405816 0
Mechanisms: Brain activity and connectivity of ‘the social brain’ using functional magnetic resonance imaging (fMRI)
Timepoint [2] 405816 0
6 weeks post intervention commencement
Secondary outcome [3] 406661 0
Social Cognition Task: Reading the Mind in the Eyes (Baron-Cohen et al., 2001)
Timepoint [3] 406661 0
6 weeks post intervention commencement
Secondary outcome [4] 406662 0
Social Cognition Task: The Awareness of Social
Inference Test (TASIT) (McDonald, Flanagan, Rollins, and Kinch, 2003)
Timepoint [4] 406662 0
6 weeks post intervention commencement
Secondary outcome [5] 406663 0
General functioning: Australian of Quality of Life (AQoL) (Richardson & Hawthorne 1998)
Timepoint [5] 406663 0
6 weeks post intervention commencement
Secondary outcome [6] 406664 0
General functioning: Revised Self-Efficacy Scale (RSES) (McDermott, 1995)
Timepoint [6] 406664 0
6 weeks post intervention commencement

Eligibility
Key inclusion criteria
Participants will i) be aged between 18-55 years (inclusive); ii) have a primary diagnosis of BDD according to the Diagnostic and Statistical Manual-5 (DSM-5); iii) score of 24 or higher on the BDD-YBOCS (to ensure at least moderate symptom severity); iv) have an estimated IQ of 70 or higher as assessed using the Test of Premorbid Functioning (TOPF) to ensure no intellectual disability and study instructions are understood; v) have been stabilised on psychotropic medications, if prescribed, for 8weeks or longer; vi) be right-handed (to meet eligibility for MRI); vii) utilising effective contraception if female and of childbearing age; and viii) have capacity to consent to the study. Further, BDD patients frequently report co-morbid depression, social anxiety and psychoses. To ensure our sample is representative, patients with co-morbidities will be included.
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded if i) substance use disorder is present; ii) they are unable to meaningfully converse in, or read, English; iii) they have metal implants or a history of claustrophobia (to meet eligibility for an MRI); iv) neuroendocrine dysfunction or steroid use is present; vi) they have been diagnosed with any known neurological disorder; v) they are currently pregnant or breastfeeding, vi) have an ongoing sinus condition and vii) history of hypersensitivity to oxytocin.

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)
central randomisation by phone/computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis
Recruitment data:
Descriptive statistics will be used to summarise assessments of recruitment.

Clinical and cognitive data:
Primary and Secondary Outcomes Baseline values for the two groups will be compared using chi-squared tests of association for categorical variables (or Fisher’s exact test for small samples) and univariate ANOVA tests (or Kruskal-Wallis tests) for continuous variables. Any significant clinical differences are unlikely, due to the random allocation of participants across conditions. For the primary analysis, an intention-to-treat (ITT) analysis will be conducted using hierarchical linear models with individuals entered as a random effect to account for correlated readings. The dependent variable will be BDD-YBOCS scores and the independent variables will be Group (OXT versus placebo), Visit and the interaction term Visit by Group (together with any clinical variables found to significantly differ between the groups at baseline). The same analytic approach will be used for the secondary outcomes (social cognition and general functioning measures). Exploratory analyses will be performed by re-running the models with Visit 3 (12 weeks) included to examine for sustainability of oxytocin across primary and secondary outcomes.

fMRI data:
Mechanisms Data will be analysed using standard procedures within Statistical Parametric Mapping 12. Our initial approach will focus on conventional brain activation mapping (via general linear model (GLM) subtraction tests). We will also complete connectivity analyses, specifically Dynamic Causal Models (DCMs). Analyses using Visit 1 and 2 data, using Linear Mixed Effects (LME) will account for within-subject covariance across time, via fixed and random intercepts and slopes as well as time-lagged covariance on the residuals and interactions.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
21/03/2022
Actual
Date of last participant enrolment
Anticipated
30/04/2023
Actual
Date of last data collection
Anticipated
31/07/2023
Actual
Sample size
Target
46
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 310682 0
Government body
Name [1] 310682 0
Victorian State Government (Victorian Medical Research Acceleration Fund)
Country [1] 310682 0
Australia
Primary sponsor type
University
Name
Swinburne University of Technology
Address
Swinburne University of Technology
John Street, Hawthorn,
Melbourne, Victoria, 3122
Country
Australia
Secondary sponsor category [1] 311904 0
None
Name [1] 311904 0
Address [1] 311904 0
Country [1] 311904 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 310267 0
Swinburne University of Technology
Ethics committee address [1] 310267 0
Swinburne University of Technology
John Street, Hawthorn,
Melbourne, Victoria, 3122
Ethics committee country [1] 310267 0
Australia
Date submitted for ethics approval [1] 310267 0
02/07/2021
Approval date [1] 310267 0
Ethics approval number [1] 310267 0

Summary
Brief summary
BDD is one of the most debilitating chronic mental health conditions, with impacts across multiple domains of functioning. Approximately 2% of the Australian population live with this serious disorder. Reappropriated pharmacological and psychological treatments (developed for mental health disorders with some similar symptoms, i.e. social anxiety disorder (SAD)) have efficacy for some people with BDD; however, most patients remain symptomatic and impaired, and many fail to respond at all. Thus, there is an urgent and immediate need for new BDD-targeted treatments given this significant clinical gap. There are only a few researchers worldwide attempting to improve the knowledge gaps in our understanding of BDD in a bid to develop novel interventions. Our CI team represents one of these groups. We have pilot data using a single dose of intranasal oxytocin (OXT) that restored activity in the ‘social brain’ (i.e. amygdala) in a double-blind placebo-controlled trial of BDD patients (d=0.78). This study seeks funding to extend and expand this world-leading work. Patients with BDD have a chronic illness course that has a major negative impact on social engagement, leading to social isolation and a quality of life that is worse than that associated with many chronic physical illnesses, let alone other psychiatric disorders (e.g. SAD). People with BDD are socially anxious, fear negative evaluations, hide their perceived appearance “flaws” from others, disconnect from family and friends, become depressed and are often suicidal. Despite these prominent social impacts, no treatments for BDD address social affiliation directly. We postulate (supported by our pilot data) that treatments which directly address social aspects of BDD, that is intranasal OXT, will have the potential to achieve symptom reduction/remission as well as substantially improve social functioning (i.e. reduced isolation and a better quality of life). Thus, we are proposing to conduct an innovative phase II randomised-controlled trial (RCT) to investigate whether daily intranasal OXT compared to placebo is an effective intervention for the treatment of BDD symptoms as well as related social impairments.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 117062 0
Prof Susan Rossell
Address 117062 0
Swinburne University of Technology
John Street, Hawthorn,
Melbourne, Victoria, 3122
Country 117062 0
Australia
Phone 117062 0
+61 414493784
Fax 117062 0
Email 117062 0
srossell@swin.edu.au
Contact person for public queries
Name 117063 0
Dr Erica Neill
Address 117063 0
Swinburne University of Technology
John Street, Hawthorn,
Melbourne, Victoria, 3122
Country 117063 0
Australia
Phone 117063 0
+61 414423573
Fax 117063 0
Email 117063 0
eneill@swin.edu.au
Contact person for scientific queries
Name 117064 0
Prof Susan Rossell
Address 117064 0
Swinburne University of Technology
John Street, Hawthorn,
Melbourne, Victoria, 3122
Country 117064 0
Australia
Phone 117064 0
+61 414493784
Fax 117064 0
Email 117064 0
srossell@swin.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
14937Ethical approval  eneill@swin.edu.au This study has been conditionally approved by Swin... [More Details]



Results publications and other study-related documents

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