St. John's Wort Extract LI 160 for the Treatment of Atypical Depression
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 201
研究概览
简要总结
The aim of tis study is to assess the efficacy and safety of Jarsin® 300 mg as an acute treatment in mild to moderate depression with atypical features.
详细描述
The general picture of depression is still that of the traditionally called endogenous type, which is also the form that was characterized extensively in clinical trials. Atypical depression with reversed vegetative signs, such as hyperphagia or hypersomnia, is traditionalla neglected, demonstrated by the fact that in the most widely used depression scales, such as the Hamilton Depression Scale, melancholic symptoms have a specific weight, while, by contrast, reversed vegetative signs are not included. This etablishes a tendency to underestimate the severity of atypical depression.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Mild to moderate depression (ICD-10 F32.0, F32.1) with atypical features according to DSM-IV, lasting at least 3 months
- •Female and male Caucasians aged 18 to 70 years
- •At least one of HAMD-28 scale items 22-26 scores >1
排除标准
- 未提供
研究组 & 干预措施
1
干预措施: Placebo (Drug)
2
干预措施: St. John's Wort extract (Drug)