Clinical Study of Compound Ciwujia Granules in the Treatment of Depression

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)