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临床试验/NCT02009371
NCT02009371已完成不适用

A Clinical Study of Light Therapy on Depressive Episodes of Bipolar Disorder

Peking University1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2013年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
80
试验地点
1
主要终点
Reducing rate of HAMD

研究概览

简要总结

The purpose of this study is to investigate the efficacy and safety of light-emitting diode(LED) light therapy on Chinese patients with Depressive Episodes of Bipolar Disorder and to gather prime research data and application parameters of LED light source which is not currently available in China.

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
Double (Participant, Outcomes Assessor)

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

入选标准

  • ages 18 to 65 years
  • comply with the DSM-IV diagnosis of Bipolar I or II Disorder and a current depressive episode
  • HAMD score ≥17 points
  • intake of just one particular psychotropic drug(a mood stabilizer or an atypical antipsychotic drug) except of antidepressants and lasted 2 weeks.

排除标准

  • inability to provide informed consent;
  • previous treatment with BLT
  • presence of another major psychiatric illness such as schizophrenia, schizoaffective disorder, lifetime alcohol or substance dependence
  • diagnosed with a rapid-cycling bipolar disorder or currently in the mixed state or YMRS score>12 points
  • use of antidepressants medications
  • significant medical illness such as diabetes mellitus,heart failure, renal failure, severe liver function abnormalities,hyperthyroidism or hypothyroidism
  • pregnancy;
  • received magnified electroconvulsive therapy orRepetitive Transcranial Magnetic Stimulation in the past 3 months
  • an eye condition that could be negatively affected by bright light
  • suicidal risk or other factor making trial participation clinically inappropriate.

结局指标

主要结局

Reducing rate of HAMD

时间窗: Change from baselin to 2 weeks after

We used HAMD to evaluate the major state of depression.

次要结局

  • Reducing rate of CGI(Change from baseline to 2 week after)

研究者

发起方
Peking University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Xin Yu

President

Peking University

研究点 (1)

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