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A Study of Chinese Medicine Treating Depression

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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

Tracking Information
First Submitted Date August 16, 2016
First Posted Date August 19, 2016
Last Update Posted Date August 19, 2016
Study Start Date June 2016
Estimated Primary Completion Date May 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 18, 2016)
  • Relapse rate [ Time Frame: 2 years ]
    It is the percentage of the relapse of depression including the total number of relapse cases.
  • Suicide rate [ Time Frame: 2 years ]
    The suicide rate includes the percentage of the cases committing suicide and the successful cases.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: August 18, 2016)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • The time of relapse [ Time Frame: 2 years ]
  • The time of committing suicide [ Time Frame: 2 years ]
    It refers to the time of committing suicide and the time of success.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: August 18, 2016)
  • Laboratory examination [ Time Frame: 2 years ]
    Blood RT, Hepatic function and Renal function
  • 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.
  • Number of participants with adverse events [ Time Frame: 2 years ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title A Study of Chinese Medicine Treating Depression
Official Title A Multicentre Prospective Cohort Study of Traditional Chinese Medicine Treating Depression With The Use of Cloud Data
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.

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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Depressive subjects with proven primary depression will be asked to participate in this study.
Condition Depression
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.
    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.
Study Groups/Cohorts
  • Traditional Chinese Medicine
    Including Zishui Qinggan Yin,Xiaoyao San, Longdan Xiegan Tang, Guipi Decoction, Ningshen Dingzhi Wan, HuangLian-EJiao decoction and Jiaotai Wan.
    Intervention: Drug: Traditional Chinese Medicine
  • TCM plus antidepressants
    This is a integrative therapy that refers to a new treating system including TCM and antidepressants.
    Interventions:
    • Drug: Traditional Chinese Medicine
    • Drug: Antidepressants
  • 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.
    Intervention: Drug: Antidepressants
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: August 18, 2016)
4600
Original Estimated Enrollment Same as current
Estimated Study Completion Date May 2020
Estimated Primary Completion Date May 2020   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Wenjun Sun, MD, PHD +86 18910259376 doctorsunwenjun@126.com
Contact: Miao Qu, MD, PHD qumiaotcm@126.com
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT02873234
Other Study ID Numbers 201507001-12
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Qisheng Tang, The Third Affiliated Hospital of Beijing University of Chinese Medicine
Study Sponsor The Third Affiliated Hospital of Beijing University of Chinese Medicine
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
Investigators
Study Director: Qisheng Tang, MD, PHD The Third Affiliated Hospital of Beijing University of Chinese Medicine
PRS Account The Third Affiliated Hospital of Beijing University of Chinese Medicine
Verification Date August 2016