A Phase 4 interventional study of Compound Ciwujia Granules and placebo in Depression - Major Depressive Disorder and Depression Disorders, sponsored by Shanghai Mental Health Center. Active, not recruiting at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-04-23.
Sponsored by Shanghai Mental Health Center · Phase 4, Interventional, and Treatment
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:
Participants are required to complete the following procedures:
8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.
This study's planned enrollment of 60 is below the median of 84 across 6,720 interventional studies indexed under Depression.
Browse Depression studies →Shanghai Mental Health Center is the lead sponsor of 267 studies on the registry; 93 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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;
1. Take placebo twice daily for 8 weeks; 2. Continue concomitant SSRI medication therapy throughout the treatment period
Drug: placebo
1. Take Compound Ciwujia Granules twice daily for 8 weeks; 2. Continue concomitant SSRI medication therapy throughout the treatment period;
Drug: Compound Ciwujia Granules
Take Compound Ciwujia Granules or placebo twice daily for 8 weeks; Continue concomitant SSRI medication therapy throughout the treatment period;
1. Take placebo twice daily for 8 weeks; 2. Continue concomitant SSRI medication therapy throughout the treatment period;
The change rate of Hamilton Depression Rating Scale-17#HAMD-17# after treatmen
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
Time frame: From enrollment to the end of the treatment at 8 weeks
Hamilton Anxiety Rating Scale#HAMA
HAMA scale is used to assess the severity of anxiety symptoms in patients with neurotic disorders and other conditions. Previous studies have reported good reliability and validity for this scale. The scores from all 14 items are summed to give a total score, which indicates the overall severity of anxiety: \< 17: Mild severity; 18-24: Mild to moderate severity; 25-30: Moderate to severe severity.
Time frame: From enrollment to the end of treatment at 8 weeks
Pittsburgh sleep quality index#PSQI#
PSQI is used to assess sleep quality over the past month. It is suitable for evaluating sleep quality in patients with sleep disorders and mental disorders, as well as in the general population. The total score ranges from 0 to 21 points. A total score of \>7 is commonly used as the cutoff threshold for determining the presence of subjective sleep problems.
Time frame: From enrollment to the end of the treatment at 8 weeks
Treatment Emergent Symptom Scale#TESS#
Among comparable scales, it provides the most comprehensive item coverage-assessing both common adverse symptoms/signs and multiple laboratory findings. The Treatment Emergent Symptom Scale (TESS) requires clinicians to evaluate each symptom across three dimensions: Severity, Relationship to Intervention, and Action Taken. Severity is rated on a 0-4 scale: 0\. = Absence of the symptom; 1. = Occasional presence of the symptom; 2. = Mild severity, no impairment to routine functioning; 3. = Moderate severity, producing some impairment to routine functioning; 4. = Severe, causing significant impairment or disability to routine functioning.
Time frame: From enrollment to the end of treatment at 8 weeks
Clinical Global Impression-global improvement#CGI-GI#
The Clinical Global Impression (CGI) scale is a comprehensive global assessment instrument. Originally developed by the World Health Organization (WHO) for the International Pilot Study of Schizophrenia (IPSS), it is designed to evaluate clinical treatment outcomes.The Global Improvement (GI) component requires clinicians to assess the degree of improvement or worsening in the patient's condition relative to baseline status. This evaluation compares the patient's current clinical state with their baseline condition at study entry, utilizing an 8-point Likert scale ranging from 0 to 7 for scoring.
Time frame: From enrollment to the end of treatment at 8 weeks
Serum Inflammatory Factors
Serum inflammatory factors refer to cytokines, chemokines, acute-phase proteins, and other immune mediators present in bloodstream circulation that participate in systemic inflammatory responses. collection of 5 ml fasting venous blood to measure serum levels of C-reactive protein (CRP), interleukin-6 (IL-6), interleukin-1β (IL-1β), and tumor necrosis fac-tor-α (TNF-α) using enzyme-linked immunosorbent assay (ELISA).
Time frame: From enrollment to the end of treatment at 8 weeks
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This study is active, not recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Shanghai Mental Health Center