Major Depressive Disorder (MDD)Phase 4JOYSNCT06749470
A Randomized, Double-blind, Placebo-controlled, Multicenter Clinical Study on the Treatment of Depression with Jieyu Chufan Capsules
A Phase 4 study testing Jieyu Chufan Capsules and Jieyu Chufan Capsules simulant in people with Major Depressive Disorder (MDD), run by Central South University.
Trial summary
To evaluate the efficacy of Jieyu Chufan Capsules, with placebo as the control, in combination with SSRIs in patients with moderate and severe depression. To observe the safety of Jieyu Chufan Capsules and its effects in improving the side effects of SSRIs. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depressive Disorder (MDD)
- What is being tested?
- Jieyu Chufan Capsules and Jieyu Chufan Capsules simulant
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 480 participants
- Where
- No sites listed yet
- Study dates
- 22 Dec 2024to 31 Dec 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
- Aged 18-65 years (inclusive);
- With first-episode or relapsed depression that meets the DSM-5 diagnostic criteria;
- With a Hamilton's Depression Scale (HAMD-17) score of ≥18 at enrollment;
- Receiving no antidepressants within 2 weeks (fluoxetine within 6 weeks) prior to enrollment;
- Willing to sign the informed consent form (ICF).
Who cannot join
- Meeting the DSM-5 diagnostic criteria for mental disorders other than depression (e.g., patients with schizophrenia spectrum and other psychiatric disorders, bipolar and related disorders, compulsive and related disorders, etc.);
- With refractory depression (no response to adequate treatment with 2 or more antidepressants) as determined by the investigator or previously diagnosed;
- At a significant risk of suicide (HAMD-17 Item 3 (suicide) score ≥3) as judged by the investigator, or with a history of suicide attempts in the last year;
- Receiving non-drug therapies, such as electric convulsive therapy (ECT), repetitive transcranial magnetic stimulation (rTMS), and systematic psychotherapy 10 or more times in the last 6 months;
- With other serious chronic diseases such as severe thyroid disease, Parkinson's disease, tumor, epilepsy, and severe rheumatism;
- With clinically significant abnormalities in 12-lead ECG that may affect the safety of the subject, including but not limited to acute myocardial ischemia, myocardial infarction, severe arrhythmia, or significantly prolonged QTc (QTc >450 ms in men and >470 ms in women);
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- With severe hepatic and renal insufficiency, i.e., aspartate transaminase (AST) ≥1.5 × upper limit of normal (ULN) or alanine aminotransferase (ALT) ≥1.5 × ULN, and serum creatinine (Scr) ≥1.5× ULN;
- Allergic to the investigational drug or its ingredients;
- In lactation, of childbearing potential, or planning to be pregnant;
- With alcohol and drug dependence;
- Participating in another clinical study within 1 month prior to enrollment or for the time being.
- Not suitable for participation in this study due to potential risks or other factors as considered by the investigator.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
To evaluate the efficacy of Jieyu Chufan Capsules, with placebo as the control, in combination with SSRIs in patients with moderate and severe depression.
To observe the safety of Jieyu Chufan Capsules and its effects in improving the side effects of SSRIs.
Read the detailed description
Major depressive disorder (MDD), a common affective mental disorder caused by a variety of reasons, is mainly clinically manifested as significant and persistent low mood, loss of interest, retardation of thinking, pessimism, lack of initiative, self-guilt, loss of appetite, sleep disorders, and paranoia, often accompanied by various systemic discomfort that is inconsistent with objective examinations, and in severe cases, suicidal thoughts and behaviors[1]. Although there has never been a name called "depression" in ancient literature of traditional Chinese medicine, it has been long recognized since it is similar to many diseases in Chinese medicine literature (such as "depression syndrome" and "lily disease"). Depression is a common mental disorder that affects about one fifth people in a certain period in their lives.
According to the data disclosed by the WHO, there are more than 350 million people suffering from depression in the world, with an increase of about 18% in the past decade. According to the prevalence report of China Mental Health Survey (CMHS) in 2019[2], for depressive disorders, the lifetime prevalence was 6.8% and the 12-month prevalence was 3.6% in China, among which, for depression, the lifetime prevalence was 3.4%, and the 12-month prevalence was 2.1%. With the acceleration of the pace of modern life, its prevalence is spreading. Moreover, the pandemic of COVID-19 resulted in a 27.6% increase in global cases of major depressive disorder[3]. It is estimated that by 2030, depressive disorders will surpass tumors and cardiovascular and cerebrovascular diseases to become the largest disease burden in the world[4]. For the time being, there are limited treatment measures for depressive disorders, and about 30%-40% of patients have developed to refractory depression due to insensitivity to existing monoamine antidepressants[5]. Monoamine antidepressants have shortcomings such as slow action, residual symptoms, more adverse reactions, and long-term medication, while novel fast-acting antidepressants also have the problems of drug addiction and neurotoxicity[6], so its treatment is facing a new dilemma.
Traditional Chinese medicine has been used for prevention and treatment of various depressive disorders for more than two thousand years, and it costs less and has achieved reliable clinical efficacy and caused less toxic side effects. Traditional Chinese medicine believes that emotional factors, such as anger, sorrow, sadness, and too much thinking, result in liver dysfunction, spleen dysfunction, mental dysfunction, and then multiple viscera dysfunction, and long-term liver depression generates pathogenic fire and fire burns body fluid to produce phlegm, thus forming the critical pathogenesis of depression, i.e., qi stagnation, phlegm condensation, and fire stagnation. The prescription of Jieyu Chufan Capsules, originated from the Classical Prescriptions of Zhang Zhongjing, is prepared by modifying the Pinellia and Magnolia Decoction and the Cape jasmine and Magnolia Decoction. Since 1997, modified Jieyu Chufan Capsules has been used to treat 12,000 outpatient cases, including 445 cases of depression and anxiety. The phase III clinical study of Jieyu Chufan Capsules[7] showed that Jieyu Chufan Capsules effectively improved depression and anxiety and effectively alleviated the physical symptoms of patients with mild to moderate depressive disorders, and the incidence of adverse reactions was comparable to that of placebo and significantly lower than that of fluoxetine.
The prescription of Jieyu Chufan Capsules, originated from the Classical Prescriptions and developed based on clinical application, has significant clinical efficacy in clearing heat and relieving fidgetiness, activating qi and eliminating phlegm. The randomized, double-blind, placebo-controlled, multicenter clinical study will be conducted to further evaluate the efficacy and safety of Jieyu Chufan Capsules in the treatment of symptoms related to moderate to severe depression in a wider population. The reliable evidence-based medical evidence can provide reference for clinical application of the drug.
- Conditions
- Major Depressive Disorder (MDD)
- Being tested
- Jieyu Chufan Capsules, Jieyu Chufan Capsules simulant
- Keywords
- Jieyu Chufan Capsules, TCM, Major Depressive Disorder (MDD)
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Jieyu Chufan CapsulesDrug
4 capsules, tid; 8 weeks
Jieyu Chufan Capsules simulantDrug
4 capsules, tid; 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Test Group | Experimental | Jieyu Chufan Capsules Strength: 0.4 g/capsule, 3 × 12 capsules/plate/box Administration: 4 capsules, tid, 8 weeks Receives: Drug: Jieyu Chufan Capsules |
| Control Group | Placebo comparator | Jieyu Chufan Capsules Placebo Strength: 0.4 g/capsule, 3 × 12 capsules/plate/box. Administration: 4 capsules, tid; 8 week Receives: Drug: Jieyu Chufan Capsules simulant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HAMD-17 score from baseline at Week 8.
Measured: From enrollment to the end of treatment at 8 weeks
Secondary outcomes (7)
Response rate in HAMD-17 at Week 8 relative to baseline
Measured: From enrollment to the end of treatment at 8 weeks
Remission rate in HAMD-17 at Week 8 relative to baseline
Measured: From enrollment to the end of treatment at 8 weeks
Change in HAMA score from baseline at Week 8
Measured: From enrollment to the end of treatment at 8 weeks
Change in QIDS-SR16 score from baseline at Week 8
Measured: From enrollment to the end of treatment at 8 weeks
Change in GAD-7 score from baseline at Week 8
Measured: From enrollment to the end of treatment at 8 weeks
Change in SHAPS score from baseline at Week 8
Measured: From enrollment to the end of treatment at 8 weeks
Change in SDS score from baseline at Week 8
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 posted27 Dec 2024
- Study start22 Dec 2024 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive Disorder (MDD)Studies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized, double-blind, placebo-controlled, multicenter clinical study.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 480 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central South University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lingjiang Li, Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06749470
- Sponsor's protocol ID
- 2024-10-22-674
- Acronym
- JOYS
- Status last verified
- Oct 2024
- First submitted
- 23 Dec 2024
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Considering subject privacy
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Multicenter Clinical Study on the Treatment of Depression with Jieyu Chufan Capsules
- ClinicalTrials.gov ID
- NCT06749470
- Acronym / sponsor ID
- JOYS / 2024-10-22-674
- Conditions
- Major Depressive Disorder (MDD)
- Keywords
- Jieyu Chufan Capsules, TCM, Major Depressive Disorder (MDD)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 480 participants (estimated)
- Lead sponsor
- Central South UniversityUniversity, hospital or other
- Study start
- 22 Dec 2024 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 27 Dec 2024 (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 evaluate the efficacy of Jieyu Chufan Capsules, with placebo as the control, in combination with SSRIs in patients with moderate and severe depression.
To observe the safety of Jieyu Chufan Capsules and its effects in improving the side effects of SSRIs.
Detailed description
Major depressive disorder (MDD), a common affective mental disorder caused by a variety of reasons, is mainly clinically manifested as significant and persistent low mood, loss of interest, retardation of thinking, pessimism, lack of initiative, self-guilt, loss of appetite, sleep disorders, and paranoia, often accompanied by various systemic discomfort that is inconsistent with objective examinations, and in severe cases, suicidal thoughts and behaviors[1]. Although there has never been a name called "depression" in ancient literature of traditional Chinese medicine, it has been long recognized since it is similar to many diseases in Chinese medicine literature (such as "depression syndrome" and "lily disease"). Depression is a common mental disorder that affects about one fifth people in a certain period in their lives.
According to the data disclosed by the WHO, there are more than 350 million people suffering from depression in the world, with an increase of about 18% in the past decade. According to the prevalence report of China Mental Health Survey (CMHS) in 2019[2], for depressive disorders, the lifetime prevalence was 6.8% and the 12-month prevalence was 3.6% in China, among which, for depression, the lifetime prevalence was 3.4%, and the 12-month prevalence was 2.1%. With the acceleration of the pace of modern life, its prevalence is spreading. Moreover, the pandemic of COVID-19 resulted in a 27.6% increase in global cases of major depressive disorder[3]. It is estimated that by 2030, depressive disorders will surpass tumors and cardiovascular and cerebrovascular diseases to become the largest disease burden in the world[4]. For the time being, there are limited treatment measures for depressive disorders, and about 30%-40% of patients have developed to refractory depression due to insensitivity to existing monoamine antidepressants[5]. Monoamine antidepressants have shortcomings such as slow action, residual symptoms, more adverse reactions, and long-term medication, while novel fast-acting antidepressants also have the problems of drug addiction and neurotoxicity[6], so its treatment is facing a new dilemma.
Traditional Chinese medicine has been used for prevention and treatment of various depressive disorders for more than two thousand years, and it costs less and has achieved reliable clinical efficacy and caused less toxic side effects. Traditional Chinese medicine believes that emotional factors, such as anger, sorrow, sadness, and too much thinking, result in liver dysfunction, spleen dysfunction, mental dysfunction, and then multiple viscera dysfunction, and long-term liver depression generates pathogenic fire and fire burns body fluid to produce phlegm, thus forming the critical pathogenesis of depression, i.e., qi stagnation, phlegm condensation, and fire stagnation. The prescription of Jieyu Chufan Capsules, originated from the Classical Prescriptions of Zhang Zhongjing, is prepared by modifying the Pinellia and Magnolia Decoction and the Cape jasmine and Magnolia Decoction. Since 1997, modified Jieyu Chufan Capsules has been used to treat 12,000 outpatient cases, including 445 cases of depression and anxiety. The phase III clinical study of Jieyu Chufan Capsules[7] showed that Jieyu Chufan Capsules effectively improved depression and anxiety and effectively alleviated the physical symptoms of patients with mild to moderate depressive disorders, and the incidence of adverse reactions was comparable to that of placebo and significantly lower than that of fluoxetine.
The prescription of Jieyu Chufan Capsules, originated from the Classical Prescriptions and developed based on clinical application, has significant clinical efficacy in clearing heat and relieving fidgetiness, activating qi and eliminating phlegm. The randomized, double-blind, placebo-controlled, multicenter clinical study will be conducted to further evaluate the efficacy and safety of Jieyu Chufan Capsules in the treatment of symptoms related to moderate to severe depression in a wider population. The reliable evidence-based medical evidence can provide reference for clinical application of the drug.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A randomized, double-blind, placebo-controlled, multicenter clinical study.
| Arm | Type | Receives |
|---|---|---|
| Test Group | Experimental | Drug: Jieyu Chufan CapsulesJieyu Chufan Capsules Strength: 0.4 g/capsule, 3 × 12 capsules/plate/box Administration: 4 capsules, tid, 8 weeks |
| Control Group | Placebo comparator | Drug: Jieyu Chufan Capsules simulantJieyu Chufan Capsules Placebo Strength: 0.4 g/capsule, 3 × 12 capsules/plate/box. Administration: 4 capsules, tid; 8 week |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged 18-65 years (inclusive);
- With first-episode or relapsed depression that meets the DSM-5 diagnostic criteria;
- With a Hamilton's Depression Scale (HAMD-17) score of ≥18 at enrollment;
- Receiving no antidepressants within 2 weeks (fluoxetine within 6 weeks) prior to enrollment;
- Willing to sign the informed consent form (ICF).
Key exclusion criteria (12 listed)
- Meeting the DSM-5 diagnostic criteria for mental disorders other than depression (e.g., patients with schizophrenia spectrum and other psychiatric disorders, bipolar and related disorders, compulsive and related disorders, etc.);
- With refractory depression (no response to adequate treatment with 2 or more antidepressants) as determined by the investigator or previously diagnosed;
- At a significant risk of suicide (HAMD-17 Item 3 (suicide) score ≥3) as judged by the investigator, or with a history of suicide attempts in the last year;
- Receiving non-drug therapies, such as electric convulsive therapy (ECT), repetitive transcranial magnetic stimulation (rTMS), and systematic psychotherapy 10 or more times in the last 6 months;
- With other serious chronic diseases such as severe thyroid disease, Parkinson's disease, tumor, epilepsy, and severe rheumatism;
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 |
|---|---|---|
| Jieyu Chufan Capsules4 capsules, tid; 8 weeks | Drug | Test Group |
| Jieyu Chufan Capsules simulant4 capsules, tid; 8 weeks | Drug | Control Group |
Primary outcome
Change in HAMD-17 score from baseline at Week 8.
Time frame: From enrollment to the end of treatment at 8 weeks
7 secondary outcomes
Response rate in HAMD-17 at Week 8 relative to baseline
Time frame: From enrollment to the end of treatment at 8 weeks
Remission rate in HAMD-17 at Week 8 relative to baseline
Time frame: From enrollment to the end of treatment at 8 weeks
Change in HAMA score from baseline at Week 8
Time frame: From enrollment to the end of treatment at 8 weeks
Change in QIDS-SR16 score from baseline at Week 8
Time frame: From enrollment to the end of treatment at 8 weeks
Change in GAD-7 score from baseline at Week 8
Time frame: From enrollment to the end of treatment at 8 weeks
Change in SHAPS score from baseline at Week 8
Time frame: From enrollment to the end of treatment at 8 weeks
Change in SDS score from baseline at Week 8
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 27 Dec 2024.
- Individual participant dataSharing planned: No. Considering subject privacy
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Jieyu Chufan Capsules and Jieyu Chufan Capsules simulant in people with Major Depressive Disorder (MDD), run by Central South University.
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 5 inclusion and 12 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 27 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Jin Liu, Doctor (+86 19832188333, 383505858@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in HAMD-17 score from baseline at Week 8. (time frame: From enrollment to the end of 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 27 Dec 2024.