ACTRN12616001546448招募中1 期
An open-label pilot trial to determine efficacy and tolerability of N-acetyl cysteine treatment for body dysmorphic disorder
St Vincent's Hospital Melbourne0 个研究点目标入组 20 人开始时间: 2016年11月9日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •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
排除标准
- •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)
研究者
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