Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study of Chinese Medicine Treating Depression

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02873234
Recruitment Status : Recruiting
First Posted : August 19, 2016
Last Update Posted : August 19, 2016
Sponsor:
Collaborators:
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
Information provided by (Responsible Party):
Qisheng Tang, The Third Affiliated Hospital of Beijing University of Chinese Medicine

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.


Condition or disease Intervention/treatment
Depression 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.


Layout table for study information
Study Type : Observational
Estimated Enrollment : 4600 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Multicentre Prospective Cohort Study of Traditional Chinese Medicine Treating Depression With The Use of Cloud Data
Study Start Date : June 2016
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine


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 Name: 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 Name: 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.




Primary Outcome Measures :
  1. Relapse rate [ Time Frame: 2 years ]
    It is the percentage of the relapse of depression including the total number of relapse cases.

  2. Suicide rate [ Time Frame: 2 years ]
    The suicide rate includes the percentage of the cases committing suicide and the successful cases.


Secondary Outcome Measures :
  1. Self-rating Depression Scale (SDS) [ Time Frame: 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.

  2. Self-reporting Inventory (SCL-90) [ Time Frame: 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.

  3. Hamilton Depression Rating Scale of 24 items (HAMD) [ Time Frame: before recruiting ]
    Differences between groups are evaluated by change of total scores from the study intake to every 3 months in 2 years.

  4. Social Disability Screening Schedule (SDSS) [ Time Frame: 2 years ]
    Differences between groups are evaluated by change of total scores from the study intake to every 3 months in 2 years.

  5. Traditional Chinese Medicine syndrome score [ Time Frame: 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.

  6. Recovery Rate [ Time Frame: 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.

  7. Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: 2 years ]
    Differences between groups are evaluated by change of total scores from the study intake to every 3 months in 2 years.

  8. Mini-mental State Examination (MMSE) [ Time Frame: 2 years ]
    Differences between groups are evaluated by change of total scores from the study intake to every 3 months in 2 years.

  9. Montreal Cognitive Assessment Scale (MoCA) [ Time Frame: 2 years ]
    Differences between groups are evaluated by change of total scores from the study intake to every 3 months in 2 years.

  10. The time of relapse [ Time Frame: 2 years ]
  11. The time of committing suicide [ Time Frame: 2 years ]
    It refers to the time of committing suicide and the time of success.


Other Outcome Measures:
  1. Laboratory examination [ Time Frame: 2 years ]
    Blood RT, Hepatic function and Renal function

  2. Treatment Emergent Symptom Scale (TESS) [ Time Frame: 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.

  3. Number of participants with adverse events [ Time Frame: 2 years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Depressive subjects with proven primary depression will be asked to participate in this study.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02873234


Contacts
Layout table for location contacts
Contact: Wenjun Sun, MD, PHD +86 18910259376 doctorsunwenjun@126.com
Contact: Miao Qu, MD, PHD qumiaotcm@126.com

Locations
Layout table for location information
China, Beijing
The Third Affiliated Hospital of Beijing University of Chinese Medicine Recruiting
Beijing, Beijing, China, 100029
Contact: Wenjun Sun, MD, PHD    +86 18910259376    doctorsunwenjun@126.com   
Sponsors and Collaborators
The Third Affiliated Hospital of Beijing University of Chinese Medicine
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
Investigators
Layout table for investigator information
Study Director: Qisheng Tang, MD, PHD The Third Affiliated Hospital of Beijing University of Chinese Medicine

Layout table for additonal information
Responsible Party: Qisheng Tang, MD, PHD, The Third Affiliated Hospital of Beijing University of Chinese Medicine
ClinicalTrials.gov Identifier: NCT02873234     History of Changes
Other Study ID Numbers: 201507001-12
First Posted: August 19, 2016    Key Record Dates
Last Update Posted: August 19, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Qisheng Tang, The Third Affiliated Hospital of Beijing University of Chinese Medicine:
Telemedicine
Chinese Medicine syndrome differentiation
Long-term study
Relapse rate
Suicide rate
Antidepressants
Additional relevant MeSH terms:
Layout table for MeSH terms
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Antidepressive Agents
Psychotropic Drugs