Taurine as an Anti-manic Agent: a Double-blind Placebo-controlled Study.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Scores on standardized measures of manic and depressive symptoms (HAM-D, MADRS, YMRS)
研究概览
简要总结
The purpose of this study is to determine whether the amino acid taurine has effects on mood stability in bipolar disorder.
详细描述
Taurine is an amino acid that has some actions similar to mood stabilizers. Taurine is widely sold as a component of over-the-counter mood enhancing agents. However, controlled studies examining the mood effects of taurine are limited. An initial study in this laboratory looked at taurine's mood effects in individuals with bipolar disorder. This follow-up study is designed to further examine taurine's effects on manic symptoms. Subjects in the current follow-up study will add taurine or placebo to their current treatment regimen. Both depressive and manic symptoms will be tracked for three months to determine whether the addition of taurine affects mood symptoms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 68 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •bipolar disorder, type I bipolar disorder, type II mania hypomania mixed manic symptoms
排除标准
- •significant medical or psychiatric co-morbidity pregnancy or planning pregnancy current substance abuse or dependence
研究组 & 干预措施
placebo
cellulose
干预措施: taurine (Drug)
active drug
taurine
干预措施: taurine (Drug)
结局指标
主要结局
Scores on standardized measures of manic and depressive symptoms (HAM-D, MADRS, YMRS)
时间窗: 12 weeks
MADRS and YMRS
次要结局
- Side-effect ratings, general health ratings(12 weeks)
- Drop-outs due to medication changes(12 weeks)
研究者
Beth L. Murphy MD, PhD
Principal Investigator
Mclean Hospital