Atorvastatin Plus Escitalopram for Depression With Dyslipidemia
Observation on Efficacy and Safety of Atorvastatin Combined With Escitalopram in Patients With Depressive Episode Complicated by Dyslipidemia
This is a clinical observation study. We want to learn more about two common prescription medicines used together for adults. These medicines treat low mood and high blood fat.
The two medicines are escitalopram for mood symptoms and atorvastatin for high blood fat. Both medicines are approved and routinely used in hospitals.
This study answers two simple questions:
- Does taking these two medicines together improve patients' mood?
- Does this medicine combination improve blood fat levels and have safe results? Study participants are adult patients who have symptoms of depression and high blood fat. This study uses no experimental drugs or new medical devices. All treatment follows standard hospital care.
During the study, participants take their regular medicines as prescribed by their doctors. The study team collects routine health information during normal clinic visits. We check mood scores and blood fat test results. We also record any mild side effects, such as dizziness or stomach upset.
This study adds no extra tests, no extra procedures, and no extra costs for participants. Joining this study is voluntary. Participants may stop at any time. Stopping the study will not change their regular medical care. All personal health data stays private and protected.
研究概览
详细说明
研究类型
注册 (实际的)
联系人和位置
学习地点
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Hebei
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Hengshui、Hebei、中国、053800
- Hengshui City Seventh People's Hospital
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
取样方法
研究人群
描述
Inclusion Criteria:
1.Meet the diagnostic criteria for depressive episode in the International Classification of Diseases, 10th Revision (ICD-10), with a total score of the 17-item Hamilton Depression Rating Scale (HAMD-17) ≥ 17 at admission.
2.Subjects are diagnosed with mild-to-moderate dyslipidemia if any one of the following fasting venous blood lipid indicators is satisfied, referring to the Chinese Guidelines for Lipid Management (Primary Care Version, 2024): Total cholesterol (TC) 5.2-6.19 mmol/L, triglycerides (TG) 1.7-2.25 mmol/L, low-density lipoprotein cholesterol (LDL-C) 3.4-4.1 mmol/L, high-density lipoprotein cholesterol (HDL-C) <1.0 mmol/L.
3.Aged 18 to 65 years old, without gender restriction. 4.Complete clinical medical records, laboratory test results and scale follow-up data; able to cooperate with 4-week full follow-up, scale assessment and repeated blood lipid examination.
5.Voluntarily participate in this study and sign written informed consent.
Exclusion Criteria:
1.Combined with severe organic lesions of vital organs such as severe cardiac insufficiency, liver cirrhosis and chronic renal failure.
2.Previously diagnosed with other mental disorders including schizophrenia, bipolar disorder and organic mental disorders.
3.History of allergy to atorvastatin or SSRIs antidepressants. 4.Regular use of statin lipid-lowering drugs or other 5.antidepressant/anxiolytic drugs within the past 1 month.
6.Long-term abuse history of psychoactive substances such as alcohol and opioids.
Concurrent participation in other clinical drug intervention studies. 7.Pregnant or lactating women.
学习计划
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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Escitalopram plus atorvastatin combination group
Participants take routine escitalopram and atorvastatin simultaneously to treat depressive episode and dyslipidemia.
Follow-up data are collected to observe therapeutic effect and adverse reactions.
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Patients with depressive episode and dyslipidemia receive standard oral escitalopram combined with atorvastatin as routine clinical treatment.
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Escitalopram monotherapy control group
Patients receive only escitalopram monotherapy as the control group to compare clinical indicators with the combined medication group.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in total score of the 17-item Hamilton Depression Rating Scale (HAMD-17)
大体时间：4 weeks after baseline enrollment
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Full Name: Hamilton Depression Rating Scale (HAMD-17) Score Range: 0 to 52 points.
A score of 0 indicates the absence of depressive symptoms, while a maximum score of 52 represents the most severe depressive state.
Higher scores correspond to more severe depressive symptoms.
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4 weeks after baseline enrollment
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合作者和调查者
调查人员
- 首席研究员：bei bei zhang, Bachelor's degree、Hengshui City Seventh People's Hospital
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- 2025002
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
- Raw data contains sensitive personal medical information of patients with depressive disorder, and data sharing may lead to privacy leakage of subjects.
- This is not an academic degree research, and there is no pre-arranged data sharing mechanism for external investigators.
- The signed informed consent of participants does not authorize the disclosure of complete individual data to third-party researchers, so IPD sharing is not permitted.
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
在美国制造并从美国出口的产品
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