A Multicenter Real-World Study of Shugan Jieyu Capsules in the Treatment of Depression
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Total effective rate based on Hamilton Depression Scale-17 (HAMD-17) score at 12 weeks of treatment
研究概览
简要总结
To observe the efficacy and safety of Shugan Jieyu Capsules in treating patients with varying degrees of depression in real-world clinical settings, and to provide data references for optimizing integrated traditional Chinese and Western medicine treatment strategies.
详细描述
Depression is a mood disorder caused by various factors, characterized by prominent and persistent depressive symptomatology and severe impairment of social functioning. The severity of depression is typically classified based on the number and type of symptoms and the degree of functional impairment, and is divided into mild, moderate, and severe. Although symptoms may remit spontaneously in some patients with mild depression, a subset may progress to severe depression within one year; without treatment, this can lead to functional impairment, reduced quality of life, and even chronicity. Current treatment for moderate-to-severe depression remains primarily pharmacological, with selective serotonin reuptake inhibitors (SSRIs) being among the most commonly used antidepressants in clinical practice. Traditional Chinese medicine (TCM) often contains multiple active ingredients. Compared with Western medicines, the advantages of TCM are not only reflected in its efficacy, but also in the protection of patients' overall health and improvement of quality of life.
Existing studies have demonstrated the efficacy advantages of integrated TCM-Western medicine approaches, which can produce synergistic effects, shorten the time to antidepressant onset, improve medication adherence, reduce adverse reactions, enhance quality of life, and improve clinical remission rates and safety. However, most existing studies focus on patients with a specific severity of depression using a fixed combination of a particular TCM and antidepressant. For patients with different severity of depression, how to better leverage the advantages of integrated treatment-especially by adjusting individualized regimens based on patient response during treatment-remains an important yet underexplored area.
Previous clinical studies of Shugan Jieyu Capsules have been predominantly randomized controlled trials (RCTs), conducted in relatively fixed settings, focusing on patients with a specific severity of depression and using fixed treatment regimens. Building on the confirmed efficacy from those RCTs, the present study expands the scope to include patients with different severity of depression and selects initial treatment regimens based on severity. During the study, treatment regimens will be flexibly adjusted according to changes in patient condition and drug response. The aim is to evaluate the real-world effectiveness of TCM-Western medicine integration based on Shugan Jieyu Capsules under conditions more representative of routine clinical practice, while exploring how to apply Shugan Jieyu Capsules more effectively and conveniently for patients with different severity of depression, thereby providing practical and actionable treatment strategies for clinical use.
Outpatients and inpatients with depression will be recruited. Eligible patients will be enrolled after screening. After enrollment, demographic data will be collected, symptoms and scale scores recorded, and relevant laboratory tests performed. The corresponding treatment regimen will be administered according to the severity of depression. Outcome evaluations will be performed at 4, 8, 12, 16, and 24 weeks of treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 13 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meet the diagnostic criteria for depression according to the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5);
- •Aged 13-65 years (inclusive), male or female;
- •No antidepressants taken within at least 14 days before screening (patients who have received fluoxetine treatment must have discontinued it for at least 28 days before screening);
- •Voluntarily sign the informed consent form and comply with all study visits, examinations, and treatments as required by the protocol.
排除标准
- •Treatment-resistant depression (poor clinical response to adequate doses and durations of two or more antidepressants with different mechanisms, or poor clinical response to adequate doses and durations of antidepressant TCMs) or depression induced by psychoactive substances;
- •Patients who meet the diagnostic criteria for other mental disorders in the DSM-5 (such as schizophrenia spectrum disorders, bipolar disorder);
- •Patients with serious suicidal tendencies (HAMD-17 item 3 score ≥ 3) or homicidal tendencies;
- •Patients with severe or unstable cardiovascular, cerebrovascular, hepatic, renal, endocrine, digestive, hematological, or other medical conditions;
- •Known or suspected history of allergy to Hypericum perforatum or Eleutherococcus senticosus;
- •Pregnant or breastfeeding women;
- •Patients currently receiving treatment with any other investigational drug;
- •Other patients who are not suitable for participation in this clinical trial.
研究组 & 干预措施
Mild depression group, Moderate depression group, Severe depression group
干预措施: Shugan Jieyu Capsules (Drug)
结局指标
主要结局
Total effective rate based on Hamilton Depression Scale-17 (HAMD-17) score at 12 weeks of treatment
时间窗: From enrollment to the end of treatment at 12 weeks
Hamilton Depression Scale-17 (HAMD-17); minimum value: 0，maximum value: 52; higher scores mean a worse outcome.
次要结局
- Total effective rate based on Hamilton Depression Scale-17 (HAMD-17) score at 4, 8, 16, and 24 weeks of treatment(From enrollment to the end of treatment at 24 weeks)
- Remission rate, reduction rate, and change of Hamilton Depression Scale-17 (HAMD-17) score at 4, 8, 12, 16, and 24 weeks of treatment(From enrollment to the end of treatment at 24 weeks)
- Total effective rate, remission rate, reduction rate, and change of Hamilton Anxiety Scale (HAMA) score at 4, 8, 12, 16, and 24 weeks of treatment(From enrollment to the end of treatment at 24 weeks)
- Change in Dimensional Anhedonia Rating Scale (DARS) score from baseline at 4, 8, 12, 16, and 24 weeks of treatment(From enrollment to the end of treatment at 24 weeks)
- Change in Pittsburgh sleep quality index (PSQI) score from baseline at 4, 8, 12, 16, and 24 weeks of treatment(From enrollment to the end of treatment at 24 weeks)
- Change in Perceived Deficit Questionnaire for Depression (PDQ-D) score from baseline at 4, 8, 12, 16, and 24 weeks of treatment(From enrollment to the end of treatment at 24 weeks)
- Change in Fatigue Severity Scale (FSS) score from baseline at 4, 8, 12, 16, and 24 weeks of treatment(From enrollment to the end of treatment at 24 weeks)
- Change in Epworth Sleepiness Scale (ESS) score from baseline at 4, 8, 12, 16, and 24 weeks of treatment(From enrollment to the end of treatment at 24 weeks)
- Change in Gastrointestinal Symptom Rating Scale (GSRS) score from baseline at 4, 8, 12, 16, and 24 weeks of treatment(From enrollment to the end of treatment at 24 weeks)
- Change in Clinical Global Impression Scale (CGI) score from baseline at 4, 8, 12, 16, and 24 weeks of treatment(From enrollment to the end of treatment at 24 weeks)
- Change in Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF) score from baseline at 12 and 24 weeks of treatment(At 12 and 24 weeks of treatment)
研究者
Si Tianmei
Vice President of Peking University Sixth Hospital; Director of the Department of Psychopharmacology, Peking University Sixth Hospital
Peking University Sixth Hospital