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Clinical Trials in China / NCT07085143
Active, not recruiting Phase 4

Clinical Study of Compound Ciwujia Granules in the Treatment of Depression

NCT07085143 · tracked via the Priya Life Science China tracker
Sponsor
Shanghai Mental Health Center
Phase
Phase 4
Started
2025-10-01
Last updated
2026-04-23

Condition(s) studied

Depression - Major Depressive DisorderDepression Disorders

Investigational drug(s) / intervention(s)

Compound Ciwujia Granulesplacebo

Compound Ciwujia Granules: Take Compound Ciwujia Granules or placebo twice daily for 8 weeks; Continue concomitant SSRI medication therapy throughout the treatment period;

placebo: 1. Take placebo twice daily for 8 weeks; 2. Continue concomitant SSRI medication therapy throughout the treatment period;

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
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)

Primary outcome measure(s)

  • The change rate of Hamilton Depression Rating Scale-17#HAMD-17# after treatmen — From enrollment to the end of the treatment at 8 weeks
    Reduction rate = (Baseline HAMD-17 score - Week 4 HAMD-17 score) / Baseline HAMD-17 score. A HAMD-17 response rate ≥50% is defined as an effective treatment

Trial sites (1)

FacilityCityRegionStatus
Shanghai Mental Health Center Shanghai Shanghai Municipality

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07085143 on ClinicalTrials.gov ↗ ← All trials in China