An open-label pilot trial of N-acetyl cysteine treatment for body dysmorphic disorder

Phase 1

Recruiting

• Conditions: Body dysmorphic disorder; Mental Health - Other mental health disorders

• Registration Number: ACTRN12616001546448
• Lead Sponsor: St Vincent's Hospital Melbourne

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-11-09
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 20

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
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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

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Body Dysmorphic Disorder Modification of the Yale-Brown Obsessive-Compulsive Scale (BDD-YBOCS), clinician administered[Baseline, Week 2, Week 4, Week 6, Week 8. Week 10, Week 12, Week 14, Week 16, 8 weeks follow-up (Week 24)]