NCT02873234

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
4,600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 16, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 19, 2016

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2020

Completed
Last Updated

August 19, 2016

Status Verified

August 1, 2016

Enrollment Period

3.9 years

First QC Date

August 16, 2016

Last Update Submit

August 18, 2016

Conditions

Depression

Keywords

TelemedicineChinese Medicine syndrome differentiationLong-term studyRelapse rateSuicide rateAntidepressants

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (11)

  • Self-rating Depression Scale (SDS)

    2 years

  • Self-reporting Inventory (SCL-90)

    2 years

  • Hamilton Depression Rating Scale of 24 items (HAMD)

    before recruiting

  • Social Disability Screening Schedule (SDSS)

    2 years

  • Traditional Chinese Medicine syndrome score

    2 years

  • +6 more secondary outcomes

Other Outcomes (3)

  • Laboratory examination

    2 years

  • Treatment Emergent Symptom Scale (TESS)

    2 years

  • Number of participants with adverse events

    2 years

Study Arms (3)

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

TCM plus antidepressants

This is a integrative therapy that refers to a new treating system including TCM and antidepressants.

Drug: Traditional Chinese MedicineDrug: 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.

Drug: Antidepressants

Interventions

Traditional Chinese MedicineDRUG

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.

Also known as: Chinese Medicine, Chinese Herb Medicine
TCM plus antidepressantsTraditional Chinese Medicine
AntidepressantsDRUG

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

AntidepressantsTCM plus antidepressants

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Third Affiliated Hospital of Beijing University of Chinese Medicine

Beijing, Beijing Municipality, 100029, China

RECRUITING

MeSH Terms

Conditions

Depression

Interventions

Medicine, Chinese TraditionalAntidepressive Agents

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Medicine, East Asian TraditionalMedicine, TraditionalComplementary TherapiesTherapeuticsPsychotropic DrugsCentral Nervous System AgentsTherapeutic UsesPharmacologic ActionsChemical Actions and Uses

Study Officials

  • Qisheng Tang, MD, PHD

    The Third Affiliated Hospital of Beijing University of Chinese Medicine

    STUDY DIRECTOR

Central Study Contacts

Wenjun Sun, MD, PHD

CONTACT

+86 18910259376doctorsunwenjun@126.com

Miao Qu, MD, PHD

CONTACT

qumiaotcm@126.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PHD

Study Record Dates

First Submitted

August 16, 2016

First Posted

August 19, 2016

Study Start

June 1, 2016

Primary Completion

May 1, 2020

Study Completion

May 1, 2020

Last Updated

August 19, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)