NCT00067938已完成4 期
Lamictal for Use in Treatment of Bipolar Disorder In Adults. A Practical Clinical Assessment of Tolerability and Clinical Effectiveness.
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
- 1,200
- 试验地点
- 1
- 主要终点
- The primary endpoint will be the rate of rash during 12 weeks.
研究概览
简要总结
Bipolar study of tolerability, clinical response and patient satisfaction
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of bipolar I disorder.
- •Must be on a stable regimen of psychiatric medication for at least 2 months prior to study.
- •If female, must not be pregnant, or must be incapable of conceiving or be taking steps to prevent conception.
排除标准
- •Patients with a clinically significant psychiatric or physiologic comorbidity including significant substance abuse, depression or mania which is of an unstable of progressive nature that could interfere in participation of this study.
- •Presence of untreated thyroid disease.
- •Patient is actively suicidal or homicidal.
- •Patient has history of severe hepatic or renal insufficiency.
- •Patient is currently participating in another clinical trial.
研究组 & 干预措施
Arm 1
Other
Open label single arm study
干预措施: lamotrigine (Drug)
结局指标
主要结局
The primary endpoint will be the rate of rash during 12 weeks.
时间窗: 12 Weeks
次要结局
- Change from baseline in Week 5 and Week 12 Clinical Global Impression-Bipolar version (CGI-BP) Severityand Improvement scores.(12 Weeks)
研究者
研究点 (1)
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