sing oxytocin in individuals with body dysmorphic disorder (BDD)

Phase 2

• Conditions: Body Dysmorphic Disorder; Mental Health - Other mental health disorders

• Registration Number: ACTRN12622000429752
• Lead Sponsor: Swinburne University of Technology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-03-16
• Last Update Posted: 21 March 2022

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 46

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.

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

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
BDD symptom severity on the BDD-Yale Brown Obsessive Compulsive Scale (YBOCS)[ 6 weeks post intervention commencement]

Secondary Outcome Measures

Name	Time	Method
The social cognition measure: The Hinting Task (Corcoran, Mercer & Frith, 1995)[ 6 weeks post intervention commencement];Mechanisms: Brain activity and connectivity of ‘the social brain’ using functional magnetic resonance imaging (fMRI) [ 6 weeks post intervention commencement];Social Cognition Task: Reading the Mind in the Eyes (Baron-Cohen et al., 2001)[ 6 weeks post intervention commencement];Social Cognition Task: The Awareness of SocialInference Test (TASIT) (McDonald, Flanagan, Rollins, and Kinch, 2003) [ 6 weeks post intervention commencement];General functioning: Australian of Quality of Life (AQoL) (Richardson & Hawthorne 1998)[ 6 weeks post intervention commencement];General functioning: Revised Self-Efficacy Scale (RSES) (McDermott, 1995)[ 6 weeks post intervention commencement]