跳至主要内容
临床试验/jRCTs041180033
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

发起方
未提供

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