ACTRN12612000830897已完成2 期
A double blind, placebo controlled, randomised trial to evaluate the effect of mitochondrial agents, N-acetyl cysteine or placebo on the depressive phase of bipolar disorder
Mental Health Research Institute- University of Melbourne0 个研究点目标入组 225 人开始时间: 2012年8月7日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 225
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
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •1. Must be required to meet DSM-IV criteria for bipolar disorder (I, II or NOS)
- •2. Have a current episode of depressive illness with a MADRS score greater than or equal to 20
- •3. Have capacity to consent to the study and comply with study procedures
- •4. Using effective contraception if female, sexually active and of child bearing potential
- •5. Any form of therapy must be stable for the last month.
排除标准
- •1. Participants with known or suspected active systemic medical disorder
- •2.Recent gastrointestinal ulcers
- •3. Individuals who are pregnant or lactating
- •4. Individuals with a diagnosis of epilepsy
- •5. Individuals currently taking >250mg of n-acetylcysteine; >250mg of acetyl l-carnitine; or >25mg of coenzyme Q10
- •6. Individuals taking over 200ug of selenium/ day
- •7. Individual requiring warfarin or phenytoin
- •8. Participants currently enrolled in another intervention study
- •9. Participants who are intolerant to or have had an anaphylactic reaction to any components in the preparation.
- •10. Participants who are unable to comply with requirements of informed consent or treatment protocol.
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