NCT02873234

A Study of Chinese Medicine Treating Depression

A Multicentre Prospective Cohort Study of Traditional Chinese Medicine Treating Depression With The Use of Cloud Data

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 4,600 (estimated)
• Sponsor: The Third Affiliated Hospital of Beijing University of Chinese Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Depression

Interventions

Type	Name	Description
DRUG	Traditional 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.
DRUG	Antidepressants	Participants are treated with different antidepressants. The dosage, frequency and duration are determined according to guideline.

Timeline

• Start date: 2016-06-01
• Primary completion: 2020-05-01
• Completion: 2020-05-01
• First posted: 2016-08-19
• Last updated: 2016-08-19

Locations

1 site across 1 country: China