The Efficacy and Safety of Dayingpian in The Treatment of Bipolar Disorder
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 308
- 试验地点
- 1
- 主要终点
- Change in the Young Mania Rating Scale (YMRS) scores compared with baseline
研究概览
简要总结
The main purpose of this cohort study is to evaluate the efficiency and safety of Dayingpian to provide evidence-based medical evidence for the subsequent drug development.
详细描述
Dayingpian is a kind of formula in traditional Chinese medicine with the effect of promoting blood circulation and reducing blood stasis. It has been prescribed as an add-on in the treatment of mental disorders such as bipolar disorder. However, there is not yet much high-quality evidence of the clinical effectiveness of Dayingpian treatment. In this study, we conduct a prospective, real-world longitudinal cohort study at Shanghai Mental Health Center in China to investigate the efficacy and safety of Dayingpian for bipolar disorder patients. The observation period is 12 weeks and all participants are evaluated every 4 weeks.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 14 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meets the International Classification of Diseases-10(ICD-10) criteria for Bipolar Disorder.
- •Outpatients or inpatients in Shanghai Mental Health Center.
- •Male or female subjects aged 14-65 years.
- •education of Junior high school or above.
- •The patient fully understands and signs the informed consent form.
排除标准
- •Apparent violent aggression/suicide within the last two weeks.
- •Other patients that the investigator believes should not be included in the study.
研究组 & 干预措施
Dayingpian exposure group 1
The exposure of interest is Dayingpian. Patients in this group take Dayingpian combined with conventional mood stabilizers. The psychiatrist does not assign specific interventions to the study participants. The course of observation is 12 weeks.
干预措施: Dayingpian (Drug)
Dayingpian exposure group 1
The exposure of interest is Dayingpian. Patients in this group take Dayingpian combined with conventional mood stabilizers. The psychiatrist does not assign specific interventions to the study participants. The course of observation is 12 weeks.
干预措施: conventional mood stabilizers (Drug)
Non-exposure group
The non-exposure group is the patients who do not take Dayingpian. Patients in this group take conventional mood stabilizers. The psychiatrist does not assign specific interventions to the study participants. The course of observation is 12 weeks.
干预措施: conventional mood stabilizers (Drug)
Dayingpian exposure group 2
The exposure of interest is Dayingpian. Patients in this group take Dayingpian as monotherapy for bipolar disorder. The psychiatrist does not assign specific interventions to the study participants. The course of observation is 12 weeks.
干预措施: Dayingpian (Drug)
结局指标
主要结局
Change in the Young Mania Rating Scale (YMRS) scores compared with baseline
时间窗: 12 weeks
To assess the mania symptoms of bipolar disorder patients after 12 weeks of treatment. Patients are assessed with the scale at baseline and week 4, 8, 12(the end of study).
次要结局
- Change in total score of the Clinical Global Impression-Severity (CGI-S) scale(12 weeks)
- Response rate(12 weeks)
- Change of Traditional Chinese Medicine(TCM) syndromes scale(12 weeks)
- Change in the Montgomery-Asberg Depression Rating Scale (MADRS) scores compared with baseline(12 weeks)
- Change in total score of the Clinical Global Impression-Improvement (CGI-I) scale(12 weeks)
研究者
LI, Huafang
Executive Director of MICT
Shanghai Mental Health Center