ACTRN12616001546448
Recruiting
Phase 1
An open-label pilot trial to determine efficacy and tolerability of N-acetyl cysteine treatment for body dysmorphic disorder
St Vincent's Hospital Melbourne0 sites20 target enrollmentNovember 9, 2016
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Body dysmorphic disorder
- Sponsor
- St Vincent's Hospital Melbourne
- Enrollment
- 20
- Status
- Recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified
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