None listed
Conditions
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.
Interventions
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-we
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.
Sponsors
St Vincent's Hospital Melbourne
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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
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)
Outcome results
None listed