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

Launched by SHANGHAI MENTAL HEALTH CENTER · Jul 17, 2025

Keywords

ClinConnect Summary

This clinical trial is studying whether a traditional medicine called Compound Ciwujia Granules can help reduce symptoms of depression in people who have a specific type of depression called heart-spleen deficiency syndrome, based on Traditional Chinese Medicine. Researchers want to see if this treatment works better than a placebo, which is a harmless pill that doesn’t contain any medicine. They will also carefully watch for any side effects to make sure the treatment is safe to use.

People who might join the study are adults between 18 and 65 years old who have been diagnosed with major depressive disorder and meet certain criteria for this heart-spleen deficiency type of depression. They must have been taking a stable dose of an SSRI antidepressant (a common type of depression medicine) for at least six weeks before joining. During the study, participants will take either the Compound Ciwujia Granules or a placebo twice a day for eight weeks, while continuing their usual antidepressant. They will visit the clinic at 4 and 8 weeks for check-ups and will be followed for an additional 4 weeks after treatment ends. This study is not yet recruiting, but if eligible, participants can expect regular monitoring and support throughout the trial.

Gender

ALL

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)