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| Name | Class |
|---|---|
| Guang'anmen Hospital of China Academy of Chinese Medical Sciences | OTHER |
| Beijing HuiLongGuan Hospital | OTHER |
| The First Affiliated Hospital of Henan University of Traditional Chinese Medicine | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Traditional Chinese Medicine | Drug | Participants are treated with TCM twice per day according to syndrome differentiation. For example, the syndrome of one participant with depression is kidney deficiency. He will take Zishui Qinggan Yin twice per day before the breakfast and dinner. |
| Measure | Description | Time Frame |
|---|---|---|
| Relapse rate | It is the percentage of the relapse of depression including the total number of relapse cases. | 2 years |
| Suicide rate | The suicide rate includes the percentage of the cases committing suicide and the successful cases. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Self-rating Depression Scale (SDS) | 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 years |
| Self-reporting Inventory (SCL-90) |
| Measure | Description | Time Frame |
|---|---|---|
| Laboratory examination | Blood RT, Hepatic function and Renal function | 2 years |
| Treatment Emergent Symptom Scale (TESS) | TESS documents the presence of common side effects. Low scores or decrease in scores represent less side effects and high scores or increase in scores represent more side effects. |
Inclusion Criteria:
Subjects meeting all of the following criteria can be included in this study:
Exclusion Criteria:
Subjects meeting anyone of the following criteria will be excluded from this study:
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Depressive subjects with proven primary depression will be asked to participate in this study.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wenjun Sun, MD, PHD | Contact | +86 18910259376 | doctorsunwenjun@126.com | |
| Miao Qu, MD, PHD | Contact | qumiaotcm@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Qisheng Tang, MD, PHD | The Third Affiliated Hospital of Beijing University of Chinese Medicine | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Third Affiliated Hospital of Beijing University of Chinese Medicine | Recruiting | Beijing | Beijing Municipality | 100029 | China |
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| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D008516 | Medicine, Chinese Traditional |
| D000928 | Antidepressive Agents |
| ID | Term |
|---|---|
| D008518 | Medicine, East Asian Traditional |
| D008519 | Medicine, Traditional |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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| First Affiliated Hospital of Heilongjiang Chinese Medicine University | OTHER |
| The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine | OTHER |
| Shandong University of Traditional Chinese Medicine | OTHER |
| Capital Medical University | OTHER |
| Xiamen Hospital of Traditional Chinese Medicine | OTHER |
| Wu Xi Hospital of Traditional Chinese Medicine | UNKNOWN |
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| Antidepressants | Drug | Participants are treated with different antidepressants. The dosage, frequency and duration are determined according to guideline. |
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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 years |
| Hamilton Depression Rating Scale of 24 items (HAMD) | Differences between groups are evaluated by change of total scores from the study intake to every 3 months in 2 years. | before recruiting |
| Social Disability Screening Schedule (SDSS) | Differences between groups are evaluated by change of total scores from the study intake to every 3 months in 2 years. | 2 years |
| Traditional Chinese Medicine syndrome score | Before the study, all investigators took standardized training and conformance testing. Syndrome differentiation and syndrome scores were took by 2 investigators together, and the results needed to obtain their consent. | 2 years |
| Recovery Rate | The differences between groups are evaluated by the number and rate of recovery cases from the study intake to every 3 months in 2 years. | 2 years |
| Montgomery-Asberg Depression Rating Scale (MADRS) | Differences between groups are evaluated by change of total scores from the study intake to every 3 months in 2 years. | 2 years |
| Mini-mental State Examination (MMSE) | Differences between groups are evaluated by change of total scores from the study intake to every 3 months in 2 years. | 2 years |
| Montreal Cognitive Assessment Scale (MoCA) | Differences between groups are evaluated by change of total scores from the study intake to every 3 months in 2 years. | 2 years |
| The time of relapse | 2 years |
| The time of committing suicide | It refers to the time of committing suicide and the time of success. | 2 years |
| 2 years |
| Number of participants with adverse events | 2 years |
| D011619 | Psychotropic Drugs |
| D002491 | Central Nervous System Agents |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |