A Study of Chinese Medicine Treating Depression

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

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.

Study Overview

• Status: Unknown
• Conditions: Depression
• Intervention / Treatment: Drug: Traditional Chinese Medicine; Drug: Antidepressants

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.

• Study Type: Observational
• Enrollment (Anticipated): 4600

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100029
      • Recruiting
      • The Third Affiliated Hospital of Beijing University of Chinese Medicine
      • Contact: Wenjun Sun, MD, PHD; Phone Number: +86 18910259376; Email: doctorsunwenjun@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Depressive subjects with proven primary depression will be asked to participate in this study.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Traditional Chinese Medicine; Including Zishui Qinggan Yin,Xiaoyao San, Longdan Xiegan Tang, Guipi Decoction, Ningshen Dingzhi Wan, HuangLian-EJiao decoction and Jiaotai Wan.	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.; Other Names: Chinese Medicine, Chinese Herb Medicine
TCM plus antidepressants; This is a integrative therapy that refers to a new treating system including TCM and antidepressants.	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.; Other Names: Chinese Medicine, Chinese Herb Medicine; Drug: Antidepressants; Participants are treated with different antidepressants. The dosage, frequency and duration are determined according to guideline.
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.	Drug: Antidepressants; Participants are treated with different antidepressants. The dosage, frequency and duration are determined according to guideline.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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)	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

Other Outcome Measures

Outcome Measure	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.	2 years
Number of participants with adverse events		2 years

Collaborators and Investigators

• Sponsor: The Third Affiliated Hospital of Beijing University of Chinese Medicine
• Collaborators: Beijing HuiLongGuan Hospital; Guang'anmen Hospital of China Academy of Chinese Medical Sciences; The First Affiliated Hospital of Henan University of Traditional Chinese Medicine; Capital Medical University; First Affiliated Hospital of Heilongjiang Chinese Medicine University; Shandong University of Traditional Chinese Medicine; The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine; Xiamen Hospital of Traditional Chinese Medicine; Wu Xi Hospital of Traditional Chinese Medicine
• Investigators: Study Director: Qisheng Tang, MD, PHD, The Third Affiliated Hospital of Beijing University of Chinese Medicine

Study record dates

Study Major Dates

• Study Start: June 1, 2016
• Primary Completion (Anticipated): May 1, 2020
• Study Completion (Anticipated): May 1, 2020

Study Registration Dates

• First Submitted: August 16, 2016
• First Submitted That Met QC Criteria: August 18, 2016
• First Posted (Estimate): August 19, 2016

Study Record Updates

• Last Update Posted (Estimate): August 19, 2016
• Last Update Submitted That Met QC Criteria: August 18, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Keywords: Telemedicine; Antidepressants; Relapse rate; Chinese Medicine syndrome differentiation; Long-term study; Suicide rate
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Psychotropic Drugs; Antidepressive Agents
• Other Study ID Numbers: 201507001-12

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No