jRCTs041180033已完成不适用
Lacosamide for treatment-resistant bipolar disorder: a open-label study (Lacosamide for bipolar disorder)
未提供0 个研究点目标入组 20 人开始时间: 2018年4月16日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Single Arm Study
- 干预模型
- Single Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 20age old 至 74age old(—)
- 性别
- All
入选标准
- •The clinical trial was described in detail to the subjects, and written informed consent was obtained from all participants and their guardians.
- •patients age: 20 > years olds and < 70 years old
- •Patients met at least 2 the following inclusion criteria -Patients did not improve their symptoms using at least one mood stabilizer with adequate dose for 4 weeks or more than 4 weeks.
- •Patients did not improve their symptoms using at least one second generation antipsychotic with adequate dose for 4 weeks or more than 4 weeks.
- •Patients did not improve their symptoms using combination therapy of mood stabilizer with second generation antipsychotic with adequate dose for 4 weeks or more than 4 weeks.
排除标准
- •patients receiving electroconvulsive therapy within 6 months prior to the study enrollment.
- •no pregnancy, no lactation.
- •no severe physical illness.
- •no neurological disease.
- •patients have suicidal ideation.
- •patients judged that researchers are inappropriate to participate in the study
结局指标
主要结局
-
Clinical Global Impression-Severity
次要结局
未报告次要终点
研究者
相似试验
招募中
不适用
acosamide for treatment-resistant bipolar disorder: a open-label studytreatment-resistant bipolar disorderJPRN-UMIN000031579Fujita Health University School of Medicine20
已完成
2 期
acosamide for bipolar disorderbipolar disorderJPRN-jRCTs041180033Kishi Taro20
已完成
3 期
Lurasidone HCI - A 6-week Phase 3 Study of Patients With Bipolar I DepressionBipolar DepressionNCT01284517Sumitomo Pharma America, Inc.356
进行中(未招募)
1 期
BALANCE 2: Bipolar disorder:Antidepressant/Lamotrigine/ANtipsychotic Comparative Evaluation - BALANCE 2EUCTR2006-001317-15-GBniversity of Oxford630
终止
2 期
Trial to Assess Efficacy and Safety of Lacosamide in Subjects With Osteoarthritis of the KneeOsteoarthritisNCT00485472UCB Pharma194
