Clinical Study of Compound Ciwujia Granules in the Treatment of Depression

NCT07085143 | Active Not Recruiting Phase 4

• 1 other identifier: 2025-34
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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:
• Take Compound Ciwujia Granules or placebo twice daily for 8 weeks;
• Continue concomitant SSRIs throughout the treatment period;
• Return to the hospital for scheduled assessments at Week 4 and Week 8.

Conditions

Depression - Major Depressive Disorder; Depression Disorders

Keywords

Compound Ciwujia Granules; depression

Outcome Measures

Primary Outcomes (1)

• 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

  From enrollment to the end of the treatment at 8 weeks

Secondary Outcomes (5)

• Hamilton Anxiety Rating Scale#HAMA

  From enrollment to the end of treatment at 8 weeks

• Pittsburgh sleep quality index#PSQI#

  From enrollment to the end of the treatment at 8 weeks

• Treatment Emergent Symptom Scale#TESS#

  From enrollment to the end of treatment at 8 weeks

• Clinical Global Impression-global improvement#CGI-GI#

  From enrollment to the end of treatment at 8 weeks

• Serum Inflammatory Factors

  From enrollment to the end of treatment at 8 weeks

Study Arms (2)

control group

PLACEBO COMPARATOR

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

Drug: placebo

intervention group

EXPERIMENTAL

1. Take Compound Ciwujia Granules twice daily for 8 weeks; 2. Continue concomitant SSRI medication therapy throughout the treatment period;

Drug: Compound Ciwujia Granules

Interventions

Compound Ciwujia Granules DRUG

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

intervention group

placebo DRUG

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

control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 qualify 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)

Sponsors & Collaborators

• Shanghai Mental Health Center: lead
• Heilongjiang Quanle Pharmaceutical Co., Ltd.: collaborator

Study Sites (1)

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, 200030, China

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2025
• First Posted: July 25, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): June 20, 2026
• Study Completion (Estimated): July 30, 2026
• Last Updated: April 23, 2026

Record last verified: 2026-04

Locations

CN (1)