Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Shanghai Mental Health Center
With
Heilongjiang Quanle Pharmaceutical Co., Ltd.
Age
18–65
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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)
