RecruitingPhase 2ACTRN12622000429752

Using oxytocin in individuals with body dysmorphic disorder (BDD)

The effect of using oxytocin in individuals with body dysmorphic disorder (BDD)


Sponsor

Swinburne University of Technology

Enrollment

46 participants

Start Date

Sep 15, 2022

Study Type

Interventional

Conditions

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.


Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 55 Yearss

Inclusion Criteria1

  • 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.

Exclusion Criteria1

  • 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.

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Interventions

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.

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.


Locations(1)

VIC, Australia

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ACTRN12622000429752


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