Clinical Study of Compound Ciwujia Granules in the Treatment of Depression

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.

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.

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)