DepressionNCT02873234
A Study of Chinese Medicine Treating Depression
An observational study of Depression, run by The Third Affiliated Hospital of Beijing University of Chinese Medicine at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Depression
- What is being tested?
- Traditional Chinese Medicine and Antidepressants
- How many people
- 4,600 participants
- Where
- 1 siteChina
- Study dates
- Jun 2016to May 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Depressive subjects with proven primary depression will be asked to participate in this study.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Miao Qu, MD, PHD contact
China1 site, 1 recruiting
- Recruiting
The Third Affiliated Hospital of Beijing University of Chinese Medicine
Beijing, Beijing Municipality, 100029
Wenjun Sun, MD, PHD, +86 18910259376, doctorsunwenjun@126.com
About this study
Official title: A Multicentre Prospective Cohort Study of Traditional Chinese Medicine Treating Depression With The Use of Cloud Data
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.
Read the 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.
- Conditions
- Depression
- Being tested
- Traditional Chinese Medicine, Antidepressants
- Keywords
- Telemedicine, Chinese Medicine syndrome differentiation, Long-term study, Relapse rate, Suicide rate, Antidepressants
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional Chinese MedicineDrug
Also called Chinese Medicine, Chinese Herb 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.
AntidepressantsDrug
Participants are treated with different antidepressants. The dosage, frequency and duration are determined according to guideline.
| Study group | Role | What they receive |
|---|---|---|
| Traditional Chinese Medicine | Including Zishui Qinggan Yin,Xiaoyao San, Longdan Xiegan Tang, Guipi Decoction, Ningshen Dingzhi Wan, HuangLian-EJiao decoction and Jiaotai Wan. Receives: Drug: Traditional Chinese Medicine | |
| TCM plus antidepressants | This is a integrative therapy that refers to a new treating system including TCM and antidepressants. Receives: 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. Receives: Drug: Antidepressants |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relapse rate
It is the percentage of the relapse of depression including the total number of relapse cases.
Measured: 2 years
Suicide rate
The suicide rate includes the percentage of the cases committing suicide and the successful cases.
Measured: 2 years
Secondary outcomes (11)
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.
Measured: 2 years
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.
Measured: 2 years
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.
Measured: before recruiting
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.
Measured: 2 years
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.
Measured: 2 years
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.
Measured: 2 years
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.
Measured: 2 years
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.
Measured: 2 years
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.
Measured: 2 years
The time of relapse
Measured: 2 years
The time of committing suicide
It refers to the time of committing suicide and the time of success.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2016 (estimated)
- Study startJun 2016
- Primary completionMay 2020 (estimated)
- Study completionMay 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4,600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Third Affiliated Hospital of Beijing University of Chinese Medicine
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Principal investigator, Qisheng Tang, The Third Affiliated Hospital of Beijing University of Chinese Medicine
- Investigators
- Qisheng Tang, MD, PHD, Study director, The Third Affiliated Hospital of Beijing University of Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02873234
- Sponsor's protocol ID
- 201507001-12
- Status last verified
- Aug 2016
- First submitted
- 16 Aug 2016
- Last updated
- 19 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre Prospective Cohort Study of Traditional Chinese Medicine Treating Depression With The Use of Cloud Data
- ClinicalTrials.gov ID
- NCT02873234
- Acronym / sponsor ID
- 201507001-12
- Conditions
- Depression
- Keywords
- Telemedicine, Chinese Medicine syndrome differentiation, Long-term study, Relapse rate, Suicide rate, Antidepressants
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 4,600 participants (estimated)
- Lead sponsor
- The Third Affiliated Hospital of Beijing University of Chinese MedicineUniversity, hospital or other
- 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
- Study start
- Jun 2016
- Primary completion
- May 2020 (estimated)
- Study completion
- May 2020 (estimated)
- First posted
- 19 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Traditional Chinese Medicine | – | Drug: Traditional Chinese MedicineIncluding Zishui Qinggan Yin,Xiaoyao San, Longdan Xiegan Tang, Guipi Decoction, Ningshen Dingzhi Wan, HuangLian-EJiao decoction and Jiaotai Wan. |
| TCM plus antidepressants | – | Drug: Traditional Chinese Medicine, Drug: AntidepressantsThis is a integrative therapy that refers to a new treating system including TCM and antidepressants. |
| Antidepressants | – | Drug: AntidepressantsAntidepressants include Selective serotonin reuptake inhibitors (SSRIs), Norepinephrine-reuptake inhibitors and other antidepressants, such as Paroxetine, Citalopram, Venlafaxine, Sertraline, Trazodone, Maprotiline and so on. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Depressive subjects with proven primary depression will be asked to participate in this study.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Traditional Chinese MedicineAlso: Chinese Medicine, Chinese Herb MedicineParticipants 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. | Drug | TCM plus antidepressants, Traditional Chinese Medicine |
| AntidepressantsParticipants are treated with different antidepressants. The dosage, frequency and duration are determined according to guideline. | Drug | Antidepressants, TCM plus antidepressants |
Primary outcome
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.
11 secondary outcomes
Self-rating Depression Scale (SDS)
Time frame: 2 years
Self-reporting Inventory (SCL-90)
Time frame: 2 years
Hamilton Depression Rating Scale of 24 items (HAMD)
Time frame: before recruiting
Social Disability Screening Schedule (SDSS)
Time frame: 2 years
Traditional Chinese Medicine syndrome score
Time frame: 2 years
Recovery Rate
Time frame: 2 years
Montgomery-Asberg Depression Rating Scale (MADRS)
Time frame: 2 years
Mini-mental State Examination (MMSE)
Time frame: 2 years
Montreal Cognitive Assessment Scale (MoCA)
Time frame: 2 years
The time of relapse
Time frame: 2 years
The time of committing suicide
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Miao Qu, MD, PHD contact
Qisheng Tang, MD, PHD study director
The Third Affiliated Hospital of Beijing University of Chinese Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depression, run by The Third Affiliated Hospital of Beijing University of Chinese Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wenjun Sun, MD, PHD (+86 18910259376, doctorsunwenjun@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relapse rate (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2016.