Observation on Efficacy and Safety of Atorvastatin Combined With Escitalopram in Patients With Depressive Episode Complicated by 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:
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.
This single-center clinical observational study aims to evaluate the clinical efficacy and safety of combined escitalopram and atorvastatin treatment in adult patients diagnosed with depressive episodes accompanied by dyslipidemia. All enrolled patients will receive routine standardized clinical medication according to their doctor's professional judgment without additional experimental intervention, extra examinations, or modified medical schedules. Researchers will retrospectively and prospectively collect routine clinical data during regular follow-up, including depressive symptom scale scores and blood lipid biochemical indicators, to observe symptom improvement and blood lipid changes before and after combined medication. All adverse reactions occurring during treatment will be systematically recorded to summarize the safety profile of the dual-drug combination. This study does not involve investigational drugs, unapproved medical devices, or U.S. FDA IND/IDE-related procedures. The study strictly follows the principle of voluntary participation and confidential personal information protection, and no additional risks or economic burdens will be brought to the participants.
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.