Clinical Study of Compound Ciwujia Granules in the Treatment of Depression

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)