Outpatients or Inpatients With DepressionNCT07785284
A Multicenter Real-World Study Evaluating the Efficacy and Safety of Shugan Jieyu Capsules in the Treatment of Depression
A study testing Shugan Jieyu Capsules in people with Outpatients or Inpatients With Depression, run by Peking University at 1 site in China.
Trial summary
To observe the efficacy and safety of Shugan Jieyu Capsules in treating patients with varying degrees of depression in real-world clinical settings, and to provide data references for optimizing integrated traditional Chinese and Western medicine treatment strategies. Read more about this study
- Who is it for?
- Ages 13 to 65 years
- Conditions the study is for
- Outpatients or Inpatients With Depression
- What is being tested?
- Shugan Jieyu Capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- Sep 2026to Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 13 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Meet the diagnostic criteria for depression according to the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5);
- Aged 13-65 years (inclusive), male or female;
- No antidepressants taken within at least 14 days before screening (patients who have received fluoxetine treatment must have discontinued it for at least 28 days before screening);
- Voluntarily sign the informed consent form and comply with all study visits, examinations, and treatments as required by the protocol.
Who cannot join
- Treatment-resistant depression (poor clinical response to adequate doses and durations of two or more antidepressants with different mechanisms, or poor clinical response to adequate doses and durations of antidepressant TCMs) or depression induced by psychoactive substances;
- Patients who meet the diagnostic criteria for other mental disorders in the DSM-5 (such as schizophrenia spectrum disorders, bipolar disorder);
- Patients with serious suicidal tendencies (HAMD-17 item 3 score ≥ 3) or homicidal tendencies;
- Patients with severe or unstable cardiovascular, cerebrovascular, hepatic, renal, endocrine, digestive, hematological, or other medical conditions;
- Known or suspected history of allergy to Hypericum perforatum or Eleutherococcus senticosus;
- Pregnant or breastfeeding women;
- Patients currently receiving treatment with any other investigational drug;
- Other patients who are not suitable for participation in this clinical trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Institute of Mental Health, Peking University Sixth Hospital
Beijing, 100191
Tianmei Si, PhD, 86-010-82801960, sitianmei@bjmu.edu.cn
About this study
Official title: A Multicenter Real-World Study of Shugan Jieyu Capsules in the Treatment of Depression
To observe the efficacy and safety of Shugan Jieyu Capsules in treating patients with varying degrees of depression in real-world clinical settings, and to provide data references for optimizing integrated traditional Chinese and Western medicine treatment strategies.
Read the detailed description
Depression is a mood disorder caused by various factors, characterized by prominent and persistent depressive symptomatology and severe impairment of social functioning. The severity of depression is typically classified based on the number and type of symptoms and the degree of functional impairment, and is divided into mild, moderate, and severe. Although symptoms may remit spontaneously in some patients with mild depression, a subset may progress to severe depression within one year; without treatment, this can lead to functional impairment, reduced quality of life, and even chronicity. Current treatment for moderate-to-severe depression remains primarily pharmacological, with selective serotonin reuptake inhibitors (SSRIs) being among the most commonly used antidepressants in clinical practice. Traditional Chinese medicine (TCM) often contains multiple active ingredients. Compared with Western medicines, the advantages of TCM are not only reflected in its efficacy, but also in the protection of patients' overall health and improvement of quality of life.
Existing studies have demonstrated the efficacy advantages of integrated TCM-Western medicine approaches, which can produce synergistic effects, shorten the time to antidepressant onset, improve medication adherence, reduce adverse reactions, enhance quality of life, and improve clinical remission rates and safety. However, most existing studies focus on patients with a specific severity of depression using a fixed combination of a particular TCM and antidepressant. For patients with different severity of depression, how to better leverage the advantages of integrated treatment-especially by adjusting individualized regimens based on patient response during treatment-remains an important yet underexplored area.
Previous clinical studies of Shugan Jieyu Capsules have been predominantly randomized controlled trials (RCTs), conducted in relatively fixed settings, focusing on patients with a specific severity of depression and using fixed treatment regimens. Building on the confirmed efficacy from those RCTs, the present study expands the scope to include patients with different severity of depression and selects initial treatment regimens based on severity. During the study, treatment regimens will be flexibly adjusted according to changes in patient condition and drug response. The aim is to evaluate the real-world effectiveness of TCM-Western medicine integration based on Shugan Jieyu Capsules under conditions more representative of routine clinical practice, while exploring how to apply Shugan Jieyu Capsules more effectively and conveniently for patients with different severity of depression, thereby providing practical and actionable treatment strategies for clinical use.
Outpatients and inpatients with depression will be recruited. Eligible patients will be enrolled after screening. After enrollment, demographic data will be collected, symptoms and scale scores recorded, and relevant laboratory tests performed. The corresponding treatment regimen will be administered according to the severity of depression. Outcome evaluations will be performed at 4, 8, 12, 16, and 24 weeks of treatment.
- Being tested
- Shugan Jieyu Capsules
- Keywords
- Shugan Jieyu Capsules, depression
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shugan Jieyu CapsulesDrug
Mild depression (7<HAMD-17≤17): Shugan Jieyu Capsules (SJC): 2 caps bid. At 4w: If HAMD-17 reduction rate (RR) <20%, consider increasing SJC to 4 caps bid per guidelines. At 12w: ① If RR ≥50% or HAMD-17 ≤7, consider maintaining SJC for another 12w. ② If 20%≤RR<50%, consider maintaining SJC, increasing to 4 caps bid, or combining other therapies. ③ If RR<20%, consider increasing SJC to 4 caps bid, combining, or switching treatments.
Moderate depression (18≤HAMD-17≤24): SJC 2 caps bid; or SJC + SSRI (SSRI at label/guideline dose). At 4w: Same as mild (increase to 4 caps bid if RR<20%).
At 12w: ①-③ Same as mild. ④ If efficacy met, consider discontinuing SSRI and continuing SJC based on stability.
Severe depression (HAMD-17>24): SJC + SSRI (SJC 2 caps bid; SSRI at label/guideline dose). At 4w: Same as above (increase SJC to 4 caps bid if RR<20%). At 12w: ①-④ Same as moderate depression (including SSRI tapering if efficacy met and stable).
| Study group | Role | What they receive |
|---|---|---|
| Mild depression group, Moderate depression group, Severe depression group | Experimental | Not described Receives: Drug: Shugan Jieyu Capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total effective rate based on Hamilton Depression Scale-17 (HAMD-17) score at 12 weeks of treatment
Hamilton Depression Scale-17 (HAMD-17); minimum value: 0，maximum value: 52; higher scores mean a worse outcome.
Measured: From enrollment to the end of treatment at 12 weeks
Secondary outcomes (11)
Total effective rate based on Hamilton Depression Scale-17 (HAMD-17) score at 4, 8, 16, and 24 weeks of treatment
Hamilton Depression Scale-17 (HAMD-17); minimum value: 0, maximum value: 52; higher scores mean a worse outcome.
Measured: From enrollment to the end of treatment at 24 weeks
Remission rate, reduction rate, and change of Hamilton Depression Scale-17 (HAMD-17) score at 4, 8, 12, 16, and 24 weeks of treatment
Hamilton Depression Scale-17 (HAMD-17); minimum value: 0, maximum value: 52; higher scores mean a worse outcome.
Measured: From enrollment to the end of treatment at 24 weeks
Total effective rate, remission rate, reduction rate, and change of Hamilton Anxiety Scale (HAMA) score at 4, 8, 12, 16, and 24 weeks of treatment
Hamilton Anxiety Scale (HAMA); minimum value: 0, maximum value: 56; higher scores mean a worse outcome.
Measured: From enrollment to the end of treatment at 24 weeks
Change in Dimensional Anhedonia Rating Scale (DARS) score from baseline at 4, 8, 12, 16, and 24 weeks of treatment
Dimensional Anhedonia Rating Scale (DARS); minimum value: 0, maximum value: 68; higher scores mean a better outcome.
Measured: From enrollment to the end of treatment at 24 weeks
Change in Pittsburgh sleep quality index (PSQI) score from baseline at 4, 8, 12, 16, and 24 weeks of treatment
Pittsburgh sleep quality index (PSQI); minimum value: 0, maximum value: 21; higher scores mean a worse outcome.
Measured: From enrollment to the end of treatment at 24 weeks
Change in Perceived Deficit Questionnaire for Depression (PDQ-D) score from baseline at 4, 8, 12, 16, and 24 weeks of treatment
Perceived Deficit Questionnaire for Depression (PDQ-D); minimum value: 0, maximum value: 80; higher scores mean a worse outcome.
Measured: From enrollment to the end of treatment at 24 weeks
Change in Fatigue Severity Scale (FSS) score from baseline at 4, 8, 12, 16, and 24 weeks of treatment
Fatigue Severity Scale (FSS); minimum value: 0, maximum value: 63; higher scores mean a worse outcome.
Measured: From enrollment to the end of treatment at 24 weeks
Change in Epworth Sleepiness Scale (ESS) score from baseline at 4, 8, 12, 16, and 24 weeks of treatment
Epworth Sleepiness Scale (ESS); minimum value: 0, maximum value: 24; higher scores mean a worse outcome.
Measured: From enrollment to the end of treatment at 24 weeks
Change in Gastrointestinal Symptom Rating Scale (GSRS) score from baseline at 4, 8, 12, 16, and 24 weeks of treatment
Gastrointestinal Symptom Rating Scale (GSRS); minimum value: 0, maximum value: 45; higher scores mean a worse outcome.
Measured: From enrollment to the end of treatment at 24 weeks
Change in Clinical Global Impression Scale (CGI) score from baseline at 4, 8, 12, 16, and 24 weeks of treatment
Clinical Global Impression Scale (CGI); minimum value: 0, maximum value: 7; higher scores mean a worse outcome.
Measured: From enrollment to the end of treatment at 24 weeks
Change in Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF) score from baseline at 12 and 24 weeks of treatment
Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF); minimum value: 14, maximum value: 70; higher scores mean a better outcome.
Measured: At 12 and 24 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2026
- Study startSep 2026 (estimated)
- Primary completionJun 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Outpatients or Inpatients With 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Si Tianmei, Peking University Sixth Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07785284
- Sponsor's protocol ID
- SGJYJN-V1.1-CTP
- Status last verified
- Sep 2026
- First submitted
- 7 Aug 2026
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Real-World Study of Shugan Jieyu Capsules in the Treatment of Depression
- ClinicalTrials.gov ID
- NCT07785284
- Acronym / sponsor ID
- SGJYJN-V1.1-CTP
- Keywords
- Shugan Jieyu Capsules, depression
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 25 Aug 2026 (actual)
- 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.
To observe the efficacy and safety of Shugan Jieyu Capsules in treating patients with varying degrees of depression in real-world clinical settings, and to provide data references for optimizing integrated traditional Chinese and Western medicine treatment strategies.
Detailed description
Depression is a mood disorder caused by various factors, characterized by prominent and persistent depressive symptomatology and severe impairment of social functioning. The severity of depression is typically classified based on the number and type of symptoms and the degree of functional impairment, and is divided into mild, moderate, and severe. Although symptoms may remit spontaneously in some patients with mild depression, a subset may progress to severe depression within one year; without treatment, this can lead to functional impairment, reduced quality of life, and even chronicity. Current treatment for moderate-to-severe depression remains primarily pharmacological, with selective serotonin reuptake inhibitors (SSRIs) being among the most commonly used antidepressants in clinical practice. Traditional Chinese medicine (TCM) often contains multiple active ingredients. Compared with Western medicines, the advantages of TCM are not only reflected in its efficacy, but also in the protection of patients' overall health and improvement of quality of life.
Existing studies have demonstrated the efficacy advantages of integrated TCM-Western medicine approaches, which can produce synergistic effects, shorten the time to antidepressant onset, improve medication adherence, reduce adverse reactions, enhance quality of life, and improve clinical remission rates and safety. However, most existing studies focus on patients with a specific severity of depression using a fixed combination of a particular TCM and antidepressant. For patients with different severity of depression, how to better leverage the advantages of integrated treatment-especially by adjusting individualized regimens based on patient response during treatment-remains an important yet underexplored area.
Previous clinical studies of Shugan Jieyu Capsules have been predominantly randomized controlled trials (RCTs), conducted in relatively fixed settings, focusing on patients with a specific severity of depression and using fixed treatment regimens. Building on the confirmed efficacy from those RCTs, the present study expands the scope to include patients with different severity of depression and selects initial treatment regimens based on severity. During the study, treatment regimens will be flexibly adjusted according to changes in patient condition and drug response. The aim is to evaluate the real-world effectiveness of TCM-Western medicine integration based on Shugan Jieyu Capsules under conditions more representative of routine clinical practice, while exploring how to apply Shugan Jieyu Capsules more effectively and conveniently for patients with different severity of depression, thereby providing practical and actionable treatment strategies for clinical use.
Outpatients and inpatients with depression will be recruited. Eligible patients will be enrolled after screening. After enrollment, demographic data will be collected, symptoms and scale scores recorded, and relevant laboratory tests performed. The corresponding treatment regimen will be administered according to the severity of depression. Outcome evaluations will be performed at 4, 8, 12, 16, and 24 weeks of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mild depression group, Moderate depression group, Severe depression group | Experimental | Drug: Shugan Jieyu Capsules |
Who may qualify
- Ages
- 13 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Meet the diagnostic criteria for depression according to the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5);
- Aged 13-65 years (inclusive), male or female;
- No antidepressants taken within at least 14 days before screening (patients who have received fluoxetine treatment must have discontinued it for at least 28 days before screening);
- Voluntarily sign the informed consent form and comply with all study visits, examinations, and treatments as required by the protocol.
Key exclusion criteria (8 listed)
- Treatment-resistant depression (poor clinical response to adequate doses and durations of two or more antidepressants with different mechanisms, or poor clinical response to adequate doses and durations of antidepressant TCMs) or depression induced by psychoactive substances;
- Patients who meet the diagnostic criteria for other mental disorders in the DSM-5 (such as schizophrenia spectrum disorders, bipolar disorder);
- Patients with serious suicidal tendencies (HAMD-17 item 3 score ≥ 3) or homicidal tendencies;
- Patients with severe or unstable cardiovascular, cerebrovascular, hepatic, renal, endocrine, digestive, hematological, or other medical conditions;
- Known or suspected history of allergy to Hypericum perforatum or Eleutherococcus senticosus;
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 |
|---|---|---|
| Shugan Jieyu CapsulesMild depression (7<HAMD-17≤17): Shugan Jieyu Capsules (SJC): 2 caps bid. At 4w: If HAMD-17 reduction rate (RR) <20%, consider increasing SJC to 4 caps bid per guidelines. At 12w: ① If RR ≥50% or HAMD-17 ≤7, consider maintaining SJC for another 12w. ② If 20%≤RR<50%, consider maintaining SJC, increasing to 4 caps bid, or combining other therapies. ③ If RR<20%, consider increasing SJC to 4 caps bid, combining, or switching treatments. Moderate depression (18≤HAMD-17≤24): SJC 2 caps bid; or SJC + SSRI (SSRI at label/guideline dose). At 4w: Same as mild (increase to 4 caps bid if RR<20%). At 12w: ①-③ Same as mild. ④ If efficacy met, consider discontinuing SSRI and continuing SJC based on stability. Severe depression (HAMD-17>24): SJC + SSRI (SJC 2 caps bid; SSRI at label/guideline dose). At 4w: Same as above (increase SJC to 4 caps bid if RR<20%). At 12w: ①-④ Same as moderate depression (including SSRI tapering if efficacy met and stable). | Drug | Mild depression group, Moderate depression group, Severe depression group |
Primary outcome
Total effective rate based on Hamilton Depression Scale-17 (HAMD-17) score at 12 weeks of treatment
Time frame: From enrollment to the end of treatment at 12 weeks
Hamilton Depression Scale-17 (HAMD-17); minimum value: 0，maximum value: 52; higher scores mean a worse outcome.
11 secondary outcomes
Total effective rate based on Hamilton Depression Scale-17 (HAMD-17) score at 4, 8, 16, and 24 weeks of treatment
Time frame: From enrollment to the end of treatment at 24 weeks
Remission rate, reduction rate, and change of Hamilton Depression Scale-17 (HAMD-17) score at 4, 8, 12, 16, and 24 weeks of treatment
Time frame: From enrollment to the end of treatment at 24 weeks
Total effective rate, remission rate, reduction rate, and change of Hamilton Anxiety Scale (HAMA) score at 4, 8, 12, 16, and 24 weeks of treatment
Time frame: From enrollment to the end of treatment at 24 weeks
Change in Dimensional Anhedonia Rating Scale (DARS) score from baseline at 4, 8, 12, 16, and 24 weeks of treatment
Time frame: From enrollment to the end of treatment at 24 weeks
Change in Pittsburgh sleep quality index (PSQI) score from baseline at 4, 8, 12, 16, and 24 weeks of treatment
Time frame: From enrollment to the end of treatment at 24 weeks
Change in Perceived Deficit Questionnaire for Depression (PDQ-D) score from baseline at 4, 8, 12, 16, and 24 weeks of treatment
Time frame: From enrollment to the end of treatment at 24 weeks
Change in Fatigue Severity Scale (FSS) score from baseline at 4, 8, 12, 16, and 24 weeks of treatment
Time frame: From enrollment to the end of treatment at 24 weeks
Change in Epworth Sleepiness Scale (ESS) score from baseline at 4, 8, 12, 16, and 24 weeks of treatment
Time frame: From enrollment to the end of treatment at 24 weeks
Change in Gastrointestinal Symptom Rating Scale (GSRS) score from baseline at 4, 8, 12, 16, and 24 weeks of treatment
Time frame: From enrollment to the end of treatment at 24 weeks
Change in Clinical Global Impression Scale (CGI) score from baseline at 4, 8, 12, 16, and 24 weeks of treatment
Time frame: From enrollment to the end of treatment at 24 weeks
Change in Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF) score from baseline at 12 and 24 weeks of treatment
Time frame: At 12 and 24 weeks of treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Individual participant dataSharing planned: No
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Shugan Jieyu Capsules in people with Outpatients or Inpatients With Depression, run by Peking University 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 4 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: opening soon, as of the sponsor's last update on 8 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tianmei Si, PhD. (86-010-82801960, sitianmei@bjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total effective rate based on Hamilton Depression Scale-17 (HAMD-17) score at 12 weeks of treatment (time frame: From enrollment to the end of treatment at 12 weeks). 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 8 Sep 2026.