A Multicentre Prospective Cohort Study of Traditional Chinese Medicine Treating Depression With The Use of Cloud Data
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 4,600
- 试验地点
- 1
- 主要终点
- Suicide rate
研究概览
简要总结
Chinese Medicine syndrome differentiation has been a prevalent therapy in China for thousands of years. It is based on patients' symptoms, pulse, tongue and coating on the tongue. Therefore, the syndrome of patients and corresponding Traditional Chinese Medicine (TCM) may vary.
This multicenter prospective cohort studies the efficiency and safety of TCM compared with antidepressants. A total number of 4600 cases with primary depression are expected to be collected and divided into 3 cohorts based on the patients' requirement and choices. Patients in one group will receive TCM, and patients in the other two groups will respectively receive antidepressants only and integrated treatment of TCM and antidepressants. This study has 2 phases: treating period and the follow-up.
The main purpose of this long-term study is to evaluate the efficiency of TCM compared with antidepressants in reducing relapse and suicide rate, changing lifestyle, improving patient compliance as well as the safety.
详细描述
This multicenter prospective cohort uses a modern technique. With its help participants can assess themselves at any time and doctors can supervise patients in case of some adverse events or intervene when patients commit suicide.
The main purpose of this study is to observe the differences between cohorts. However, the intra-group differences are also needed to be evaluated, as the therapies of different participants are various. Therefore, the number of participants treated with each therapy and the time of recovery need to be counted and analyzed. This is a long-term and natural study that participants lost, drug withdrawal and changes in participants'choices of the therapy cannot be avoided. So the reason and number of the previous conditions need to be observed. The safety of TCM and antidepressants is also a considerable outcome which will be evaluated by laboratory examination, Treatment Emergent Symptom Scale (TESS) and the number of participants with adverse events.
Some of the outcomes are measured by questionnaires which can be divided into two parts. One is self-rated assessments including Self-rating Depression Scale (SDS) and Self-reporting Inventory (SCL-90). The other one is evaluated by doctors, such as Hamilton Depression Rating Scale of 24 items (HAMD), Montgomery-Asberg Depression Rating Scale (MADRS), Social Disability Screening Schedule (SDSS), Mini-mental State Examination (MMSE), Montreal Cognitive Assessment (MoCA)and Traditional Chinese Medicine syndrome score.
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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects meeting all of the following criteria can be included in this study:
- •Clinical diagnosis of depression
- •The scores of Hamilton Depression scale ( HAMD )≥18
- •With stable vital signs, conscious mind and acceptable communication ability
- •Can use the mobile phone to do self-evaluation
- •Male or female patients between 18 and 65 years old
- •Signing the informed consent and agreeing to participate in this study
排除标准
- •Subjects meeting anyone of the following criteria will be excluded from this study:
- •Depression caused by other diseases
- •Unstable vital signs
- •Severe aphasia and agnosia causing disability to communicate
- •Alcoholism and other substance dependence
- •Diagnosis of other mental disorders except depression
- •Serious hepatic or renal insufficiency
- •Pregnancy or lactation
研究组 & 干预措施
Traditional Chinese Medicine
Including Zishui Qinggan Yin,Xiaoyao San, Longdan Xiegan Tang, Guipi Decoction, Ningshen Dingzhi Wan, HuangLian-EJiao decoction and Jiaotai Wan.
干预措施: Traditional Chinese Medicine (Drug)
TCM plus antidepressants
This is a integrative therapy that refers to a new treating system including TCM and antidepressants.
干预措施: Traditional Chinese Medicine (Drug)
TCM plus antidepressants
This is a integrative therapy that refers to a new treating system including TCM and antidepressants.
干预措施: Antidepressants (Drug)
Antidepressants
Antidepressants include Selective serotonin reuptake inhibitors (SSRIs), Norepinephrine-reuptake inhibitors and other antidepressants, such as Paroxetine, Citalopram, Venlafaxine, Sertraline, Trazodone, Maprotiline and so on.
干预措施: Antidepressants (Drug)
结局指标
主要结局
Suicide rate
时间窗: 2 years
The suicide rate includes the percentage of the cases committing suicide and the successful cases.
Relapse rate
时间窗: 2 years
It is the percentage of the relapse of depression including the total number of relapse cases.
次要结局
- Self-rating Depression Scale (SDS)(2 years)
- Self-reporting Inventory (SCL-90)(2 years)
- Montreal Cognitive Assessment Scale (MoCA)(2 years)
- Recovery Rate(2 years)
- Montgomery-Asberg Depression Rating Scale (MADRS)(2 years)
- The time of committing suicide(2 years)
- The time of relapse(2 years)
- Hamilton Depression Rating Scale of 24 items (HAMD)(before recruiting)
- Social Disability Screening Schedule (SDSS)(2 years)
- Traditional Chinese Medicine syndrome score(2 years)
- Mini-mental State Examination (MMSE)(2 years)
研究者
Qisheng Tang
MD, PHD
The Third Affiliated Hospital of Beijing University of Chinese Medicine