CTRI/2024/09/073258尚未招募不适用
To assess the safety, effectiveness and utility of vortioxetine as initial line therapy in the Management of depression through an observational, multicenter Study
Torrent Pharmaceuticals Ltd.1 个研究点 分布在 1 个国家目标入组 3,500 人开始时间: 2025年7月2日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 3,500
- 试验地点
- 1
- 主要终点
- Safety assessment
研究概览
简要总结
To evaluate the safety effectiveness and utility of vortioxetine as initial line therapy in Indian patients with major depressive disorder (MDD) .
study design: Post Approval Observation Study
Duration of Observation: 4 weeks
Study Drug: vortioxetine
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •Adult Male or female patients Treatment Naïve or known cases of MDD and treated with Vortioxetine as initial line therapy.
排除标准
- •Are allergic to vortioxetine or any of the ingredients in medicine.
结局指标
主要结局
Safety assessment
时间窗: At 4 week
Usage pattern for Vortioxetine
时间窗: At 4 week
o Dose of Vortioxetine
时间窗: At 4 week
o Duration of Vortioxetine therapy
时间窗: At 4 week
o Co-prescription(s) along with Vortioxetine
时间窗: At 4 week
次要结局
- Change in depression severity based on PHQ-9 scores(Demographic pattern)
研究者
Dr Vishal Damani
OM psychiatric clinic
研究点 (1)
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