NCT00226356已完成4 期
Phase 4 Study: An Open Study of the Efficacy and Tolerability in Unipolar Depression of Augmentation of the One-carbon Cycle With L-methionine, Betaine and Folate
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Depressive symptoms
研究概览
简要总结
This study is being conducted to determine the clinical response rate for the regimen of L-methionine, betaine and folate for unipolar depression.
详细描述
The study is 6 weeks long, with 9 clinical visits. All visits will take place at our location in Massachusetts.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •DSM-IV diagnosis of a MDD or DDNOS; clinical indication for treatment of current depressive symptoms; HDS > 18; women of reproductive potential must use an acceptable method of birth control
排除标准
- •Treatment with another psychotropic drug; history of mania or hypomania; history of bipolar illness in first-degree relatives; active homicidality; pregnant; trying to become pregnant, or nursing; unstable medical condition; current substance abuse in the past month; history of sulfa allergy
研究组 & 干预措施
Supplements of L-methionine, betaine and folate
Experimental
干预措施: Supplements of L-methionine, betaine and folate (Drug)
结局指标
主要结局
Depressive symptoms
次要结局
未报告次要终点
研究者
研究点 (1)
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