Depression
Conditions
Keywords
Telemedicine, Chinese Medicine syndrome differentiation, Long-term study, Relapse rate, Suicide rate, Antidepressants
Brief summary
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.
Detailed description
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.
Interventions
DRUGTraditional Chinese Medicine
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.
DRUGAntidepressants
Participants are treated with different antidepressants. The dosage, frequency and duration are determined according to guideline.
Sponsors
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
The Third Affiliated Hospital of Beijing University of Chinese Medicine
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Relapse rate | 2 years | It is the percentage of the relapse of depression including the total number of relapse cases. |
| Suicide rate | 2 years | The suicide rate includes the percentage of the cases committing suicide and the successful cases. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Hamilton Depression Rating Scale of 24 items (HAMD) | before recruiting | Differences between groups are evaluated by change of total scores from the study intake to every 3 months in 2 years. |
| Social Disability Screening Schedule (SDSS) | 2 years | Differences between groups are evaluated by change of total scores from the study intake to every 3 months in 2 years. |
| Traditional Chinese Medicine syndrome score | 2 years | 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. |
| Recovery Rate | 2 years | 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. |
| 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. |
| Montreal Cognitive Assessment Scale (MoCA) | 2 years | Differences between groups are evaluated by change of total scores from the study intake to every 3 months in 2 years. |
| The time of relapse | 2 years | — |
| The time of committing suicide | 2 years | It refers to the time of committing suicide and the time of success. |
| Montgomery-Asberg Depression Rating Scale (MADRS) | 2 years | Differences between groups are evaluated by change of total scores from the study intake to every 3 months in 2 years. |
| Mini-mental State Examination (MMSE) | 2 years | Differences between groups are evaluated by change of total scores from the study intake to every 3 months in 2 years. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Laboratory examination | 2 years | Blood RT, Hepatic function and Renal function |
| Treatment Emergent Symptom Scale (TESS) | 2 years | 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. |
| Number of participants with adverse events | 2 years | — |
Countries
China
Contacts
Primary ContactWenjun Sun, MD, PHD
Backup ContactMiao Qu, MD, PHD
Outcome results
None listed