An Exploratory Randomized, Double-blind, Placebo-controlled Study on Compound Ciwujia Granules in the Treatment of Depression (Heart-Spleen Deficiency Syndrome)

Plain English Summary

Clinical Study of Compound Ciwujia Granules in the Treatment of Depression is a Phase 4 clinical trial sponsored by Shanghai Mental Health Center studying Depression - Major Depressive Disorder, Depression Disorders. This study will test if a traditional Chinese medicine, Compound Ciwujia Granules, can help improve symptoms of depression. It is for adults aged 18-65 diagnosed with major depression who also meet specific Traditional Chinese Medicine criteria for 'heart-spleen deficiency syndrome'. Participants will take either the study drug or a placebo (inactive substance) twice daily for 8 weeks, while continuing their current SSRI medication, and attend clinic visits. Alternatives include standard antidepressant medications (SSRIs), psychotherapy, and other complementary therapies. The trial aims to enroll 60 participants.

Official 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). 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: 1. Take Compound Ciwujia Granules or placebo twice daily for 8 weeks; 2. Continue concomitant SSRIs throughout the treatment period; 3. Return to the hospital for scheduled assessments at Week 4 and Week 8; 4. Complete a 4-week follow-up period after the 8-week treatment phase.

Who Can Participate

Here is what you need to know about eligibility for this trial. You can join if you are between 18 and 65 years old, have been diagnosed with major depression, and meet Traditional Chinese Medicine criteria for heart-spleen deficiency. You must have a specific range of scores on depression and anxiety scales and be on a stable dose of an SSRI antidepressant for at least 6 weeks. You cannot join if you have other major psychiatric disorders (besides depression), a history of significant neurological conditions, severe systemic illnesses, or are pregnant/breastfeeding. This trial is studying Depression - Major Depressive Disorder, Depression Disorders, so participants generally need a confirmed diagnosis.

What They're Measuring

The primary outcome measures how much the study drug reduces depression symptoms, as assessed by a standard rating scale, indicating its effectiveness in alleviating depressive feelings. The specific primary outcome measures are: The change rate of Hamilton Depression Rating Scale-17#HAMD-17# after treatmen (From enrollment to the end of the treatment at 8 weeks). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This is a Phase 4 (post-marketing) study of a treatment that has already received FDA approval. Phase 4 trials monitor long-term safety, effectiveness in broader patient populations, and potential interactions with other treatments in real-world settings. These studies can involve thousands of patients and help identify rare side effects that may not have appeared in earlier, smaller trials.

Why This Trial Matters

This trial explores a potential new treatment option for depression, specifically targeting a subtype defined by Traditional Chinese Medicine, which may fill a gap for patients seeking alternative or This research targets Depression - Major Depressive Disorder, Depression Disorders, where improved treatment options are needed.

Investor Insight

This trial investigates a novel herbal compound for a specific depression subtype, potentially opening a new market segment if proven effective and safe, though its competitive landscape and approval This treatment is already approved and on the market. This post-marketing study monitors real-world outcomes.

Is This Trial Right for Me?

Ask your doctor if this study is right for you, especially how it fits with your current treatment plan. You will need to take study medication daily for 8 weeks and attend clinic visits at 4 and 8 weeks, followed by a 4-week follow-up. You will continue taking your prescribed SSRI antidepressant throughout the study. The trial is being conducted at multiple sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: RANDOMIZED
• Model: PARALLEL
• Masking: QUADRUPLE
• Enrollment: 60 participants

Interventions

• DRUG: Compound Ciwujia Granules — Take Compound Ciwujia Granules or placebo twice daily for 8 weeks; Continue concomitant SSRI medication therapy throughout the treatment period;
• DRUG: placebo — 1. Take placebo twice daily for 8 weeks; 2. Continue concomitant SSRI medication therapy throughout the treatment period;

Primary Outcomes

• The change rate of Hamilton Depression Rating Scale-17#HAMD-17# after treatmen (From enrollment to the end of the treatment at 8 weeks)

Secondary Outcomes

• Hamilton Anxiety Rating Scale#HAMA (From enrollment to the end of treatment at 8 weeks)
• Pittsburgh sleep quality index#PSQI# (From enrollment to the end of the treatment at 8 weeks)
• Treatment Emergent Symptom Scale#TESS# (From enrollment to the end of treatment at 8 weeks)
• Clinical Global Impression-global improvement#CGI-GI# (From enrollment to the end of treatment at 8 weeks)
• Serum Inflammatory Factors (From enrollment to the end of treatment at 8 weeks)

Full Eligibility Criteria

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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;
* 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)

Frequently Asked Questions

Related Conditions

• Depression
• Major Depressive Disorder
• Anxiety Disorders
• Mood Disorders
• Psychiatric Disorders
• Traditional Chinese Medicine
• Herbal Medicine
• Complementary and Alternative Medicine
• Mental Health
• Neurological Disorders

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