NCT07085143进行中（未招募）4 期
An Exploratory Randomized, Double-blind, Placebo-controlled Study on Compound Ciwujia Granules in the Treatment of Depression (Heart-Spleen Deficiency Syndrome)
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The change rate of Hamilton Depression Rating Scale-17#HAMD-17# after treatmen
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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)
研究组 & 干预措施
intervention group
Experimental
- Take Compound Ciwujia Granules twice daily for 8 weeks;
- Continue concomitant SSRI medication therapy throughout the treatment period;
干预措施: Compound Ciwujia Granules (Drug)
control group
Placebo Comparator
- Take placebo twice daily for 8 weeks;
- Continue concomitant SSRI medication therapy throughout the treatment period
干预措施: placebo (Drug)
结局指标
主要结局
The change rate of Hamilton Depression Rating Scale-17#HAMD-17# after treatmen
时间窗: 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
次要结局
- Hamilton Anxiety Rating Scale#HAMA(From enrollment to the end of treatment at 8 weeks)
- Treatment Emergent Symptom Scale#TESS#(From enrollment to the end of treatment at 8 weeks)
- Serum Inflammatory Factors(From enrollment to the end of treatment at 8 weeks)
- 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)
研究者
研究点 (1)
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