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

Plain Language Summary

Simplified for easier understanding

Body dysmorphic disorder (BDD) is a serious mental health condition in which a person becomes preoccupied with perceived flaws in their appearance — flaws that are minor or not visible to others. It affects about 2% of the population and is highly debilitating, causing social isolation, depression, and significant risk of suicide. Existing treatments help some people but many do not respond fully. This study investigates whether a nasal spray of oxytocin — a naturally occurring brain hormone involved in social bonding and trust — can help treat BDD. Oxytocin may specifically address the social withdrawal and avoidance that drives much of the disability in BDD. Participants will use the oxytocin spray daily for several weeks, with brain MRI scans and clinical assessments taken before and after to measure effects. You may be eligible if you are aged 18–55, have a confirmed primary BDD diagnosis of at least moderate severity, and have been stable on any psychiatric medications for at least 8 weeks. Right-handedness is required for MRI suitability. Those with substance use disorder, neurological conditions, pregnancy, ongoing sinus conditions, or MRI contraindications would not be eligible.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

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

View Full Details on ANZCTR

For the most up-to-date information, visit the official listing.

Visit

ACTRN12622000429752


Related Trials