Depression - Major Depressive DisorderPhase 4NCT07085143
Clinical Study of Compound Ciwujia Granules in the Treatment of Depression
A Phase 4 study testing Compound Ciwujia Granules in people with Depression - Major Depressive Disorder and Depression Disorders, run by Shanghai Mental Health Center at 1 site in China.
Trial summary
The purpose of this clinical trial is to evaluate the therapeutic efficacy and safety of Compound Ciwujia Granules in treating depression disorder (heart-spleen deficiency syndrome). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depression - Major Depressive Disorder, Depression Disorders
- What is being tested?
- Compound Ciwujia Granules
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2025to 30 Jul 2026
- Phase
- Phase 4
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meets the DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, 5th Edition) diagnostic criteria for major depressive disorder (MDD) and the depressive episode criteria of the Mini-International Neuropsychiatric Interview (M.I.N.I.);
- Fulfills Traditional Chinese Medicine (TCM) diagnostic criteria for heart-spleen deficiency syndrome
- HAMD-17 (17-item Hamilton Depression Rating Scale) total score: 8-24;
- HAMA (Hamilton Anxiety Rating Scale) score ≤21;
- Outpatient participants aged 18-65 (inclusive) of either sex;
- Education level ≥ junior high school, capable of completing self-assessment scales;
- Currently on a stable dose of one SSRI for ≥6 weeks, with a CGI-GI (Clinical Global Impression - Global Improvement) score ≥4 at screening and baseline;
- Voluntary participation with signed informed consent.
Who cannot join
- Prior diagnosis or medical history of: organic mental disorder-related depression, clinically significant neurological diseases (e.g., epilepsy, encephalopathy), any neurodegenerative disorders, moderate/severe head trauma or other neurological conditions affecting CNS function;
- Current DSM-5-diagnosed psychiatric disorders (other than MDD), including:
- Schizophrenia spectrum/other psychotic disorders, Bipolar and related disorders, Anxiety disorders, OCD, or somatic symptom disorders, Substance-related/addictive disorders (excluding caffeine/nicotine), Positive urine drug screen at screening;
- Suicide risk, defined as: history of suicide attempt, investigator-assessed current significant risk, any "Yes" response to C-SSRS Items 1-5;
- Severe systemic diseases, including: significant cardiac, hepatic, or renal dysfunction, ALT/AST >1.5× upper limit of normal (ULN);
- Pregnancy/lactation, or women of childbearing potential not using effective contraception;
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- Acute/chronic conditions within 1 month: Infectious/autoimmune diseases, allergies, cancer, or stroke;
- Participation in other drug trials within 1 month;
- History of:psychosurgery, deep brain stimulation (DBS), electroconvulsive therapy (ECT)
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, 200030
About this study
Official title: An Exploratory Randomized, Double-blind, Placebo-controlled Study on Compound Ciwujia Granules in the Treatment of Depression (Heart-Spleen Deficiency Syndrome)
The purpose of this clinical trial is to evaluate the therapeutic efficacy and safety of Compound Ciwujia Granules in treating depression disorder (heart-spleen deficiency syndrome). The study primarily aims to address the following key questions:
- Can Compound Ciwujia Granules effectively alleviate depressive symptoms in patients with heart-spleen deficiency syndrome?
- What adverse reactions might participants experience while taking Compound Ciwujia Granules? Researchers will compare Compound Ciwujia Granules to a placebo (a look-alike substance that contains no drug) to see if Compound Ciwujia Granules works to treat depression disorder.
Read more
Participants are required to complete the following procedures:
- Take Compound Ciwujia Granules or placebo twice daily for 8 weeks;
- Continue concomitant SSRIs throughout the treatment period;
- Return to the hospital for scheduled assessments at Week 4 and Week 8.
- Being tested
- Compound Ciwujia Granules, placebo
- Keywords
- Compound Ciwujia Granules, depression
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Compound Ciwujia GranulesDrug
Take Compound Ciwujia Granules or placebo twice daily for 8 weeks; Continue concomitant SSRI medication therapy throughout the treatment period;
placeboDrug
- Take placebo twice daily for 8 weeks;
- Continue concomitant SSRI medication therapy throughout the treatment period;
| Study group | Role | What they receive |
|---|---|---|
| control group | Placebo comparator | 1. Take placebo twice daily for 8 weeks;
2. Continue concomitant SSRI medication therapy throughout the treatment period Receives: Drug: placebo |
| intervention group | Experimental | 1. Take Compound Ciwujia Granules twice daily for 8 weeks;
2. Continue concomitant SSRI medication therapy throughout the treatment period; Receives: Drug: Compound Ciwujia Granules |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change rate of Hamilton Depression Rating Scale-17#HAMD-17# after treatmen
Reduction rate = (Baseline HAMD-17 score - Week 4 HAMD-17 score) / Baseline HAMD-17 score. A HAMD-17 response rate ≥50% is defined as an effective treatment
Measured: From enrollment to the end of the treatment at 8 weeks
Secondary outcomes (5)
Hamilton Anxiety Rating Scale#HAMA
HAMA scale is used to assess the severity of anxiety symptoms in patients with neurotic disorders and other conditions. Previous studies have reported good reliability and validity for this scale. The scores from all 14 items are summed to give a total score, which indicates the overall severity of anxiety: < 17: Mild severity; 18-24: Mild to moderate severity; 25-30: Moderate to severe severity.
Measured: From enrollment to the end of treatment at 8 weeks
Pittsburgh sleep quality index#PSQI#
PSQI is used to assess sleep quality over the past month. It is suitable for evaluating sleep quality in patients with sleep disorders and mental disorders, as well as in the general population. The total score ranges from 0 to 21 points. A total score of >7 is commonly used as the cutoff threshold for determining the presence of subjective sleep problems.
Measured: From enrollment to the end of the treatment at 8 weeks
Treatment Emergent Symptom Scale#TESS#
Among comparable scales, it provides the most comprehensive item coverage-assessing both common adverse symptoms/signs and multiple laboratory findings. The Treatment Emergent Symptom Scale (TESS) requires clinicians to evaluate each symptom across three dimensions: Severity, Relationship to Intervention, and Action Taken.
Severity is rated on a 0-4 scale:
- = Absence of the symptom;
- = Occasional presence of the symptom;
- = Mild severity, no impairment to routine functioning;
- = Moderate severity, producing some impairment to routine functioning;
- = Severe, causing significant impairment or disability to routine functioning.
Measured: From enrollment to the end of treatment at 8 weeks
Clinical Global Impression-global improvement#CGI-GI#
The Clinical Global Impression (CGI) scale is a comprehensive global assessment instrument. Originally developed by the World Health Organization (WHO) for the International Pilot Study of Schizophrenia (IPSS), it is designed to evaluate clinical treatment outcomes.The Global Improvement (GI) component requires clinicians to assess the degree of improvement or worsening in the patient's condition relative to baseline status. This evaluation compares the patient's current clinical state with their baseline condition at study entry, utilizing an 8-point Likert scale ranging from 0 to 7 for scoring.
Measured: From enrollment to the end of treatment at 8 weeks
Serum Inflammatory Factors
Serum inflammatory factors refer to cytokines, chemokines, acute-phase proteins, and other immune mediators present in bloodstream circulation that participate in systemic inflammatory responses. collection of 5 ml fasting venous blood to measure serum levels of C-reactive protein (CRP), interleukin-6 (IL-6), interleukin-1β (IL-1β), and tumor necrosis fac-tor-α (TNF-α) using enzyme-linked immunosorbent assay (ELISA).
Measured: From enrollment to the end of treatment at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2025
- Study start1 Oct 2025
- Primary completion20 Jun 2026 (estimated)
- Study completion30 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression - Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by Shanghai Mental Health CenterThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Mental Health Center
- Sponsor type
- University, hospital or other
- Collaborators
- Heilongjiang Quanle Pharmaceutical Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07085143
- Sponsor's protocol ID
- 2025-34
- Status last verified
- Apr 2026
- First submitted
- 20 Jun 2025
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Randomized, Double-blind, Placebo-controlled Study on Compound Ciwujia Granules in the Treatment of Depression (Heart-Spleen Deficiency Syndrome)
- ClinicalTrials.gov ID
- NCT07085143
- Acronym / sponsor ID
- 2025-34
- Keywords
- Compound Ciwujia Granules, depression
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Collaborators
- Heilongjiang Quanle Pharmaceutical Co., Ltd.
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 20 Jun 2026 (estimated)
- Study completion
- 30 Jul 2026 (estimated)
- First posted
- 25 Jul 2025 (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.
The purpose of this clinical trial is to evaluate the therapeutic efficacy and safety of Compound Ciwujia Granules in treating depression disorder (heart-spleen deficiency syndrome). The study primarily aims to address the following key questions:
- Can Compound Ciwujia Granules effectively alleviate depressive symptoms in patients with heart-spleen deficiency syndrome?
- What adverse reactions might participants experience while taking Compound Ciwujia Granules? Researchers will compare Compound Ciwujia Granules to a placebo (a look-alike substance that contains no drug) to see if Compound Ciwujia Granules works to treat depression disorder.
Participants are required to complete the following procedures:
- Take Compound Ciwujia Granules or placebo twice daily for 8 weeks;
- Continue concomitant SSRIs throughout the treatment period;
- Return to the hospital for scheduled assessments at Week 4 and Week 8.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | Placebo comparator | Drug: placebo1. Take placebo twice daily for 8 weeks; 2. Continue concomitant SSRI medication therapy throughout the treatment period |
| intervention group | Experimental | Drug: Compound Ciwujia Granules1. Take Compound Ciwujia Granules twice daily for 8 weeks; 2. Continue concomitant SSRI medication therapy throughout the treatment period; |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Meets the DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, 5th Edition) diagnostic criteria for major depressive disorder (MDD) and the depressive episode criteria of the Mini-International Neuropsychiatric Interview (M.I.N.I.);
- Fulfills Traditional Chinese Medicine (TCM) diagnostic criteria for heart-spleen deficiency syndrome
- HAMD-17 (17-item Hamilton Depression Rating Scale) total score: 8-24;
- HAMA (Hamilton Anxiety Rating Scale) score ≤21;
- Outpatient participants aged 18-65 (inclusive) of either sex;
Key exclusion criteria (9 listed)
- Prior diagnosis or medical history of: organic mental disorder-related depression, clinically significant neurological diseases (e.g., epilepsy, encephalopathy), any neurodegenerative disorders, moderate/severe head trauma or other neurological conditions affecting CNS function;
- Current DSM-5-diagnosed psychiatric disorders (other than MDD), including:
- Schizophrenia spectrum/other psychotic disorders, Bipolar and related disorders, Anxiety disorders, OCD, or somatic symptom disorders, Substance-related/addictive disorders (excluding caffeine/nicotine), Positive urine drug screen at screening;
- Suicide risk, defined as: history of suicide attempt, investigator-assessed current significant risk, any "Yes" response to C-SSRS Items 1-5;
- Severe systemic diseases, including: significant cardiac, hepatic, or renal dysfunction, ALT/AST >1.5× upper limit of normal (ULN);
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 |
|---|---|---|
| Compound Ciwujia GranulesTake Compound Ciwujia Granules or placebo twice daily for 8 weeks; Continue concomitant SSRI medication therapy throughout the treatment period; | Drug | intervention group |
| placebo1. Take placebo twice daily for 8 weeks; 2. Continue concomitant SSRI medication therapy throughout the treatment period; | Drug | control group |
Primary outcome
The change rate of Hamilton Depression Rating Scale-17#HAMD-17# after treatmen
Time frame: From enrollment to the end of the treatment at 8 weeks
Reduction rate = (Baseline HAMD-17 score - Week 4 HAMD-17 score) / Baseline HAMD-17 score. A HAMD-17 response rate ≥50% is defined as an effective treatment
5 secondary outcomes
Hamilton Anxiety Rating Scale#HAMA
Time frame: From enrollment to the end of treatment at 8 weeks
Pittsburgh sleep quality index#PSQI#
Time frame: From enrollment to the end of the treatment at 8 weeks
Treatment Emergent Symptom Scale#TESS#
Time frame: From enrollment to the end of treatment at 8 weeks
Clinical Global Impression-global improvement#CGI-GI#
Time frame: From enrollment to the end of treatment at 8 weeks
Serum Inflammatory Factors
Time frame: From enrollment to the end of treatment at 8 weeks
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 23 Apr 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Compound Ciwujia Granules in people with Depression - Major Depressive Disorder and Depression Disorders, run by Shanghai Mental Health Center 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 8 inclusion and 9 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: under way, not looking for participants, as of the sponsor's last update on 23 Apr 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change rate of Hamilton Depression Rating Scale-17#HAMD-17# after treatmen (time frame: From enrollment to the end of the treatment at 8 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 23 Apr 2026.