A Study of Chinese Medicine Treating Depression

Phase

N/A

Condition

Depression

Treatment

N/A

Clinical Study ID

NCT02873234

201507001-12

Ages 18-70
All Genders

Study 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.

Eligibility Criteria

Inclusion

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

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

Study Design

June 01, 2016

May 31, 2020

Study 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.

Connect with a study center

The Third Affiliated Hospital of Beijing University of Chinese Medicine
Beijing, Beijing 100029
China
Active - Recruiting

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