Clinical trial NCT02873234: 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Depression
Keywords: Telemedicine
Chinese Medicine syndrome differentiation
Long-term study
Relapse rate
Suicide rate
Antidepressants
Lead sponsor: The Third Affiliated Hospital of Beijing University of Chinese Medicine
Sponsor class: OTHER
Collaborators: name: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
name: Beijing HuiLongGuan Hospital
name: The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
name: First Affiliated Hospital of Heilongjiang Chinese Medicine University
name: The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine
name: Shandong University of Traditional Chinese Medicine
name: Capital Medical University
name: Xiamen Hospital of Traditional Chinese Medicine
name: Wu Xi Hospital of Traditional Chinese Medicine
First posted: 2016-08-19
Enrollment: 4600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Depressive subjects with proven primary depression will be asked to participate in this study.

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.

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

Primary outcomes:
measure: Relapse rate
timeFrame: 2 years
measure: Suicide rate
timeFrame: 2 years
Secondary outcomes:
measure: Self-rating Depression Scale (SDS)
timeFrame: 2 years
measure: Self-reporting Inventory (SCL-90)
timeFrame: 2 years
measure: Hamilton Depression Rating Scale of 24 items (HAMD)
timeFrame: before recruiting
measure: Social Disability Screening Schedule (SDSS)
timeFrame: 2 years
measure: Traditional Chinese Medicine syndrome score
timeFrame: 2 years
measure: Recovery Rate
timeFrame: 2 years
measure: Montgomery-Asberg Depression Rating Scale (MADRS)
timeFrame: 2 years
measure: Mini-mental State Examination (MMSE)
timeFrame: 2 years
measure: Montreal Cognitive Assessment Scale (MoCA)
timeFrame: 2 years
measure: The time of relapse
timeFrame: 2 years
measure: The time of committing suicide
timeFrame: 2 years
Other outcomes:
measure: Laboratory examination
timeFrame: 2 years
measure: Treatment Emergent Symptom Scale (TESS)
timeFrame: 2 years
measure: Number of participants with adverse events
timeFrame: 2 years
Locations:
city: Beijing
country: China
facility: The Third Affiliated Hospital of Beijing University of Chinese Medicine
state: Beijing
Study officials:
affiliation: The Third Affiliated Hospital of Beijing University of Chinese Medicine
name: Qisheng Tang, MD, PHD
role: STUDY_DIRECTOR
References: