NCT02287259已完成4 期
A Randomized, Open Label Trial of Olanzapine Versus Lithium in the Treatment of Acute Depression in Patients With Bipolar II or Bipolar Not Otherwise Specified.
Tadashi Hasegawa1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2014年11月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change in Montgomery- Åsberg Depression Rating(MADRS)
研究概览
简要总结
Determine the efficacy and tolerability of olanzapine for treatment of acute depression in patients with bipolar II or bipolar disorder NOS compared with lithium.
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
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •major depressive episode in type2 bipolar disorder or bipolar disorder NOS.(MADRS more than 20 point)
- •18years to 65years
- •subjects who sign the informed consent document
排除标准
- •don't have Diabetes and abnormal metabolism of sugar
- •not noticed as bipolar disorder
- •have an organic brain disease
- •pregnant or breastfeeding women
- •don't have heart disease
- •have actively suicidal thought(Suicidal ideation score of MADRS is 6)
- •who are judged by the investigator to should be excluded from the study
研究组 & 干预措施
Olanzapine
Experimental
PO start with 2.5mg daily once for 7days, since then flexible dose.
干预措施: olanzapine (Drug)
Lithium
Active Comparator
PO start with 400mg daily twice for 7days, since then flexible dose.
干预措施: lithium (Drug)
结局指标
主要结局
Change in Montgomery- Åsberg Depression Rating(MADRS)
时间窗: Baseline and 8 weeks
次要结局
- Change in Young Mania Rating Scale(YMARS)(Baseline and 8 weeks)
- Clinical Global Impression for Bipolar Disorder(CGI-BP)(Baseline and 8 weeks)
- Quick Inventory of Depressive Symptomatology Japanese version(QIDS-J)(Baseline and 8 weeks)
- State Trait Anxiety Inventory Form JYZ(STAI)(Baseline and 8 weeks)
研究者
Tadashi Hasegawa
medical doctor(assistant professor)
Chiba University
研究点 (1)
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