A Study of Chinese Medicine Treating Depression

只有注册用户可以翻译文章

登陆注册

链接已保存到剪贴板

状态

赞助商

The Third Affiliated Hospital of Beijing University of Chinese Medicine

合作者

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Beijing HuiLongGuan Hospital

The First Affiliated Hospital of Henan University of Traditional Chinese Medicine

First Affiliated Hospital of Heilongjiang Chinese Medicine University

The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine

Shandong University of Traditional Chinese Medicine

Capital Medical University

Xiamen Hospital of Traditional Chinese Medicine

Wu Xi Hospital of Traditional Chinese Medicine

临床试验: NCT02873234

BioSeek: nct02873234

关键词

抗抑郁药

抽象

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.

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.

日期

最后验证:	07/31/2016
首次提交:	08/15/2016
提交的预估入学人数:	08/17/2016
首次发布:	08/18/2016
上次提交的更新:	08/17/2016
最近更新发布:	08/18/2016
实际学习开始日期:	05/31/2016
预计主要完成日期:	04/30/2020
预计完成日期:	04/30/2020

状况或疾病

Depression

干预/治疗

Drug: Traditional Chinese Medicine

Drug: Antidepressants

相

手臂组

臂	干预/治疗
Traditional Chinese Medicine Including Zishui Qinggan Yin,Xiaoyao San, Longdan Xiegan Tang, Guipi Decoction, Ningshen Dingzhi Wan, HuangLian-EJiao decoction and Jiaotai Wan.
TCM plus antidepressants This is a integrative therapy that refers to a new treating system including TCM and antidepressants.
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.

资格标准

有资格学习的年龄	18 Years 至 18 Years
有资格学习的性别	All
取样方式	Probability Sample
接受健康志愿者	是
标准	Inclusion Criteria: 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 Exclusion Criteria: 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

结果

主要结果指标

1. Relapse rate [2 years]

It is the percentage of the relapse of depression including the total number of relapse cases.

2. Suicide rate [2 years]

The suicide rate includes the percentage of the cases committing suicide and the successful cases.

次要成果指标

1. Self-rating Depression Scale (SDS) [2 years]

Differences between groups are evaluated by the change of total scores from the study starting to every 2 weeks at least during 2 years. It is assessed by patients using a mobile phone APP.

2. Self-reporting Inventory (SCL-90) [2 years]

Differences between groups are evaluated by the change of total scores from the study starting to every 2 weeks at least during 2 years. It is assessed by patients using a mobile phone APP.

3. Hamilton Depression Rating Scale of 24 items (HAMD) [before recruiting]