A Study of Chinese Medicine Treating Depression

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02873234
• Other study ID #: 201507001-12
• Status: Recruiting
• Phase: N/A
• First received: August 16, 2016
• Last updated: August 18, 2016
• Start date: June 2016
• Est. completion date: May 2020

Study information

• Verified date: August 2016
• Source: The Third Affiliated Hospital of Beijing University of Chinese Medicine
• Contact: Wenjun Sun, MD, PHD
• Phone: +86 18910259376
• Email: doctorsunwenjun[@]126.com
• Is FDA regulated: No
• Health authority: China: State Administration of Traditional Chinese Medicine of the People's Republic of China
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 4600
• Est. completion date: May 2020
• Est. primary completion date: May 2020
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

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.
• Antidepressants
Participants are treated with different antidepressants. The dosage, frequency and duration are determined according to guideline.

Locations

Country	Name	City	State
China	The Third Affiliated Hospital of Beijing University of Chinese Medicine	Beijing	Beijing

Sponsors (10)

Lead Sponsor

Collaborator

The Third Affiliated Hospital of Beijing University of Chinese Medicine

Beijing HuiLongGuan Hospital, Capital Medical University, First Affiliated Hospital of Heilongjiang Chinese Medicine University, Guang'anmen Hospital of China Academy of Chinese Medical Sciences, Shandong University of Traditional Chinese Medicine, The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine, The First Affiliated Hospital of Henan University of Traditional Chinese Medicine, Wu Xi Hospital of Traditional Chinese Medicine, Xiamen Hospital of Traditional Chinese Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Laboratory examination	Blood RT, Hepatic function and Renal function	2 years	Yes
Other	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	Yes
Other	Number of participants with adverse events		2 years	Yes
Primary	Relapse rate	It is the percentage of the relapse of depression including the total number of relapse cases.	2 years	No
Primary	Suicide rate	The suicide rate includes the percentage of the cases committing suicide and the successful cases.	2 years	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	The time of relapse		2 years	No
Secondary	The time of committing suicide	It refers to the time of committing suicide and the time of success.	2 years	No