NCT07085143Active, not recruitingPhase 4
Clinical Study of Compound Ciwujia Granules in the Treatment of Depression
An Exploratory Randomized, Double-blind, Placebo-controlled Study on Compound Ciwujia Granules in the Treatment of Depression (Heart-Spleen Deficiency Syndrome)
Source: ClinicalTrials.gov · Last updated 23 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 20 Jun 2025
- Start date
- 1 Oct 2025
- Primary completion date
- 20 Jun 2026
- Lead sponsor
- Shanghai Mental Health Center
- Diseases
- Depression
- NCT number
- NCT07085143
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 60
- From 1 Oct 2025 to the primary completion date, 20 Jun 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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;
- Participation in other drug trials within 1 month;
Other illness
- 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;
- Acute/chronic conditions within 1 month: Infectious/autoimmune diseases, allergies, cancer, or stroke;
- History of:psychosurgery, deep brain stimulation (DBS), electroconvulsive therapy (ECT)
Lab values
- Severe systemic diseases, including: significant cardiac, hepatic, or renal dysfunction, ALT/AST \>1.5× upper limit of normal (ULN);
Other
- Pregnancy/lactation, or women of childbearing potential not using effective contraception;
Who the study is looking for
- 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.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shanghai Mental Health Center Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.