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Trial registered on ANZCTR


Registration number
ACTRN12616001546448
Ethics application status
Approved
Date submitted
7/11/2016
Date registered
9/11/2016
Date last updated
14/12/2018
Date data sharing statement initially provided
14/12/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
An open-label pilot trial of N-acetyl cysteine treatment for body dysmorphic disorder
Scientific title
An open-label pilot trial to determine efficacy and tolerability of N-acetyl cysteine treatment for body dysmorphic disorder
Secondary ID [1] 290475 0
Nil known
Universal Trial Number (UTN)
Trial acronym
BDD-NAC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Body dysmorphic disorder 300844 0
Condition category
Condition code
Mental Health 300669 300669 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a 16 week, open-label pilot trial of N-acetyl cysteine in body dysmorphic disorder (BDD).

Participants with BDD will be asked to take NAC orally, alongside any treatment-as-usual, for the study duration. The daily dose will start at 1g twice daily (2g total per day) and will be increased up to a maximum of 1.5g twice daily (3g total per day), depending on (non-)response, and following a case review between the investigators. Response assessment and case review will take place at two-week intervals. For compliance monitoring, participants will be asked to return any empty bottles and/or unused capsules

Participants will be assessed for BDD symptom presence/severity and side-effects at two week intervals. Face-to-face assessment sessions will occur at baseline and weeks 8 and 16, and again at 2 months follow-up (week 24). Participants will be assessed via phone and completion of online measures at weeks 2, 4, 6, 10, 12 and 14. Primary outcome measure is the Body Dysmorphic Disorder Modification of the Yale-Brown Obsessive-Compulsive Scale (BDD-YBOCS). Assessments will be undertaken by a clinical psychologist with expertise in BDD, and medical oversight for the study will be provided by a consultant psychiatrist with expertise in the treatment and management of patients with BDD.
Intervention code [1] 296331 0
Treatment: Drugs
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 300095 0
Body Dysmorphic Disorder Modification of the Yale-Brown Obsessive-Compulsive Scale (BDD-YBOCS), clinician administered
Timepoint [1] 300095 0
Baseline, Week 2, Week 4, Week 6, Week 8. Week 10, Week 12, Week 14, Week 16, 8 weeks follow-up (Week 24)
Secondary outcome [1] 329015 0
Body Dysmorphic Disorder Modification of the Yale-Brown Obsessive-Compulsive Scale (BDD-YBOCS), self-report version
Timepoint [1] 329015 0
Baseline, Week 2, Week 4, Week 6, Week 8. Week 10, Week 12, Week 14, Week 16, 8 weeks follow-up (Week 24)
Secondary outcome [2] 329016 0
Appearance Anxiety Inventory (AAI) (self-report measure)
Timepoint [2] 329016 0
Baseline, Week 2, Week 4, Week 6, Week 8. Week 10, Week 12, Week 14, Week 16, Week 24 (8 weeks follow-up)
Secondary outcome [3] 329017 0
Dysmorphic Concern Questionnaire - Modified for past week (DCQ-C) (self-report measure)
Timepoint [3] 329017 0
Baseline, Week 2, Week 4, Week 6, Week 8. Week 10, Week 12, Week 14, Week 16, Week 24 (8 weeks follow-up)
Secondary outcome [4] 329018 0
Kessler Psychological Distress Scale (K10) (self-report measure)
Timepoint [4] 329018 0
Baseline, Week 4, Week 8. Week 12, Week 16, Week 24 (8 weeks follow-up)
Secondary outcome [5] 329019 0
Depression, Anxiety and Stress Scales, 21 item version (DASS-21) (self-report measure)
Timepoint [5] 329019 0
Baseline, Week 2, Week 4, Week 6, Week 8. Week 10, Week 12, Week 14, Week 16, Week 24 (8 weeks follow-up)
Secondary outcome [6] 329020 0
Yale-Brown Obsessive-Compulsive Scale (YBOCS), clinician administered
Timepoint [6] 329020 0
Baseline, Week 8, Week 16, Week 24 (8 weeks follow-up)
Secondary outcome [7] 329021 0
Yale-Brown Obsessive-Compulsive Scale (YBOCS), self-report version
Timepoint [7] 329021 0
Baseline, Week 2, Week 4, Week 6, Week 8. Week 10, Week 12, Week 14, Week 16, Week 24 (8 weeks follow-up)
Secondary outcome [8] 329022 0
Systematic Assessment of Treatment Emergent Effects (SAFTEE) (self-report measure; for assessment of safety and tolerability of the intervention)
Timepoint [8] 329022 0
Baseline, Week 2, Week 4, Week 6, Week 8. Week 10, Week 12, Week 14, Week 16, Week 24 (8 weeks follow-up)
Secondary outcome [9] 329024 0
World Health Organisation Quality of Life - BREF (WHOQOL-BREF) (self-report measure)
Timepoint [9] 329024 0
Baseline, Week 8, Week 16, Week 24 (8 weeks follow-up)
Secondary outcome [10] 329025 0
Body Image Quality of Life Inventory (BIQLI) (self-report measure)
Timepoint [10] 329025 0
Baseline, Week 8, Week 16, Week 24 (8 weeks follow-up)
Secondary outcome [11] 329026 0
Spatial Span Test
Timepoint [11] 329026 0
Baseline, Week 16, Week 24 (8 weeks follow-up)
Secondary outcome [12] 339834 0
Suicidal Ideation Attributes Scale (SIDAS) (self-report)
Timepoint [12] 339834 0
Baseline, Week 2, Week 4, Week 6, Week 8. Week 10, Week 12, Week 14, Week 16, Week 24 (8 weeks follow-up)

Eligibility
Key inclusion criteria
1. Aged 18 years or over
2. Lifetime DSM5 diagnosis of BDD made by a psychiatrist or clinical psychologist, confirmed with a score above 9 on the DCQ
3. Minimum moderate BDD symptom severity as indicated by BDD-YBOCS score of 15 or greater
4. Stabilised on any other medications (stable regimen for at least 2 months)
5. Capacity to consent to the study
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Individuals already taking NAC
2. Individuals who have identified as being allergic to NAC or any component of the preparation
3. Inability to comply with either the requirements of informed consent or the treatment protocol
4. Individuals who are currently prescribed nitro-glycerine (significant interaction)
5. Individuals who are diabetic and on insulin replacement (moderate interaction)
6. Individuals who are currently prescribed Aralen (moderate interaction)
7. Individuals who regularly take >200mg/day selenium
8. Individuals who are currently prescribed anticoagulant medication (excluding aspirin and non-steroidal anti-inflammatories) (moderate interaction)
9. Individuals with a known or suspected active systemic disorder
10. Individuals who have had recent gastrointestinal ulcers or renal stones
11. Females who are pregnant or lactating
Page 9 of 19
12. Individuals with epilepsy
13. Individuals enrolled in any other interventional study
14. Individuals who have had a recent (within the last 2 months) change to other medications
15. Individuals with a known autoimmune disorder
16. Individuals regularly using recreational drugs (a participation requirement is that individuals refrain from any recreational drug use for the duration of the study and follow-up period)

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
30/10/2017
Actual
17/10/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
2
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 6891 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Recruitment postcode(s) [1] 14559 0
3065 - Fitzroy

Funding & Sponsors
Funding source category [1] 294893 0
Charities/Societies/Foundations
Name [1] 294893 0
Barbara Dicker Brain Sciences Foundation
Country [1] 294893 0
Australia
Primary sponsor type
Hospital
Name
St Vincent's Hospital Melbourne
Address
41 Victoria Pde
Fitzroy VIC 3065
Country
Australia
Secondary sponsor category [1] 293730 0
University
Name [1] 293730 0
Swinburne University of Technology
Address [1] 293730 0
John St
Hawthorn VIC 3122
Country [1] 293730 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296271 0
St Vincent's Hospital Melbourne Human Research Ethics Committee D
Ethics committee address [1] 296271 0
41 Victoria Pde
Fitzroy VIC 3065
Ethics committee country [1] 296271 0
Australia
Date submitted for ethics approval [1] 296271 0
15/03/2016
Approval date [1] 296271 0
06/07/2016
Ethics approval number [1] 296271 0
Ethics committee name [2] 296272 0
Swinburne University Human Research Ethics Committee
Ethics committee address [2] 296272 0
Research Ethics Office
Swinburne Research (H68)
Swinburne University of Technology
P O Box 218
Hawthorn VIC 3122
Ethics committee country [2] 296272 0
Australia
Date submitted for ethics approval [2] 296272 0
18/10/2016
Approval date [2] 296272 0
19/10/2016
Ethics approval number [2] 296272 0

Summary
Brief summary
The aim of this study is to investigate the efficacy and tolerability of NAC in BDD. There is a growing body of research pointing to NAC's possible effectiveness in treating a range of psychiatric conditions. In particular, accumulating evidence points to its probable efficacy in treating obsessive-compulsive and related disorders including obsessive-compulsive disorder, trichotillomania, compulsive nail-biting and pathological gambling. BDD, another obsessive-compulsive spectrum disorder, is an often-debilitating condition affecting up to 2.5% of the population. This study will investigate whether NAC holds any promise as a new treatment for BDD. Participants will undergo treatment with NAC, at a starting dose of 1g twice daily (total 2g per day). Response will be assessed every two weeks and dosage will be adjusted depending on response and tolerability of the NAC, up to a maximum daily dose of 3g. Change in BDD symptoms and other scores over time will be assessed relative to baseline.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 70066 0
Prof David Castle
Address 70066 0
Department of Mental Health
St Vincent's Hospital
Level 2, 46 Nicholson St
Fitzroy VIC 3065
Country 70066 0
Australia
Phone 70066 0
+61 3 9231 4751
Fax 70066 0
Email 70066 0
david.castle@svha.org.au
Contact person for public queries
Name 70067 0
Dr Ryan Kaplan
Address 70067 0
Brain and Psychological Sciences Research Centre
Faculty of Health, Arts and Design
Swinburne University of Technology
PO Box 218
Hawthorn VIC 3122
Country 70067 0
Australia
Phone 70067 0
+61 431136523
Fax 70067 0
Email 70067 0
rkaplan@swin.edu.au
Contact person for scientific queries
Name 70068 0
Dr Ryan Kaplan
Address 70068 0
Brain and Psychological Sciences Research Centre
Faculty of Health, Arts and Design
Swinburne University of Technology
PO Box 218
Hawthorn VIC 3122
Country 70068 0
Australia
Phone 70068 0
+61 431136523
Fax 70068 0
Email 70068 0
rkaplan@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
Not approved by HREC


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.