An observational study in Depression, sponsored by The Third Affiliated Hospital of Beijing University of Chinese Medicine. Status unknown at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2016-08-19.
Sponsored by The Third Affiliated Hospital of Beijing University of Chinese Medicine · Observational
Among 357 studies in Depression with a site in China — 118 open to participants now, 137 under way, 3 of them phase 3. Depression · China.
Among the 357 studies in Depression with a site in China, this one is the 11th largest by planned enrollment of the 74 observational ones, is one of 4 that started in 2016, is one of 74 observational ones, and was the 49th registered.
8,577 studies on the registry are indexed under Depression; 1,720 are open to participants now.
This study's planned enrollment of 4,600 is above the median of 175 across 1,257 observational studies indexed under Depression.
Browse Depression studies →118 of the 357 studies in Depression with a site in China are open now, in 12 countries. Each count lists the studies.
Of the 1,088 Depression studies recruiting now, 469 (43%) set no upper age limit and 519 (48%) stop at 75 or younger; 203 take children under 18; 310 take healthy volunteers.
This study: 18 Years to 70 Years · all sexes · no healthy volunteers.
The full table on the hub →357 studies; the count open now beside each. This study's row is marked.
First in 2006; this study’s year is marked. 4 started in 2016.
Median enrollment 132 across the 283 interventional studies, 306 across the 74 observational. Of the 140 that completed or were terminated, 9 (6%) have results posted.
20 of 357 have an industry lead sponsor. The 10 most frequent:
The Third Affiliated Hospital of Beijing University of Chinese Medicine is the lead sponsor of 4 studies on the registry; 2 are open to participants now.
The Third Affiliated Hospital of Beijing University of Chinese Medicine has 1 study filed under Depression — fewer than ten, so there is no comparison to draw.
43 of the studies in Depression with a site in China that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07485595Phase 3Tasly Pharmaceutical Group Co., LtdA Study of the Effectiveness and Safety of JS1-1-01 Tablet in Patients With Moderate to Severe Depression | 2026-12-31 |
| NCT07738809Capital University of Physical Education and Sports, ChinaEffects of Exercise Intervention on Sleep Quality and Emotional Problems in College Students With Depressive Symptoms | 2026-11 |
| NCT07179913The First Hospital of Jilin UniversityThe Improvement of Low-dose Esketamine on Postoperative Depression in Patients Undergoing Bariatric Surgery With Preoperative Depression | 2026-11-20 |
| NCT07247968Min SuSubanesthetic Esketamine in Modified ECT for Severe Depression in Adolescents: Clinical and Mechanistic Study | 2026-11-20 |
| NCT07282366Jian-Jun OuVideo Intervention to Reduce Depression-related Stigma Among Adolescents | 2026-11-20 |
Among the 357 studies in Depression with a site in China, from their registry updates:
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.
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.
Depressive subjects with proven primary depression will be asked to participate in this study.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Subjects meeting all of the following criteria can be included in this study:
Exclusion Criteria:
Subjects meeting anyone of the following criteria will be excluded from this study:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Including Zishui Qinggan Yin,Xiaoyao San, Longdan Xiegan Tang, Guipi Decoction, Ningshen Dingzhi Wan, HuangLian-EJiao decoction and Jiaotai Wan.
Drug: Traditional Chinese Medicine
This is a integrative therapy that refers to a new treating system including TCM and antidepressants.
Drug: Traditional Chinese Medicine · Drug: 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 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
Participants are treated with different antidepressants. The dosage, frequency and duration are determined according to guideline.
Relapse rate
It is the percentage of the relapse of depression including the total number of relapse cases.
Time frame: 2 years
Suicide rate
The suicide rate includes the percentage of the cases committing suicide and the successful cases.
Time frame: 2 years
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 2 years
The time of relapse
Time frame: 2 years
The time of committing suicide
It refers to the time of committing suicide and the time of success.
Time frame: 2 years
Laboratory examination
Blood RT, Hepatic function and Renal function
Time frame: 2 years
Treatment Emergent Symptom Scale (TESS)
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.
Time frame: 2 years
Number of participants with adverse events
Time frame: 2 years
Plan to share: No
No publications or documents are linked to this record.
The record gives a start of Jun 2016, a primary completion of May 2020 and a completion of May 2020. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.
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The Third Affiliated Hospital of Beijing University of Chinese Medicine