NCT01428518已完成不适用
Special Drug Use Investigation for LAMICTAL Bipolar
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,036
- 主要终点
- Number of patients with any adverse drug reaction
研究概览
简要总结
This post-marketing surveillance study is designed to collect and assess information on safety and effectiveness of lamotrigine tablets in patients with bipolar disorder in routine clinical practice.
("LAMICTAL" is a trademark of the GlaxoSmithKline group of companies.)
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with bipolar disorder
- •Patients treated with lamotrigine tablets for the first time
排除标准
- •Not applicable
研究组 & 干预措施
Patients with bipolar disorder
Patients with bipolar disorder prescribed lamotrigine tablets for the first time
干预措施: Lamotrigine tablets (Drug)
结局指标
主要结局
Number of patients with any adverse drug reaction
时间窗: 1 year
次要结局
- Occurrence of skin disorder(1 year)
- Occurrence of suicide-related event and self injurious behaviour(1 year)
- Occurrence of harming others(1 year)
- Occurrence of withdrawal symptoms after treatment(1 year)
研究者
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