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.

Study Overview

• Status: Completed
• Conditions: Depressive Episode, Dyslipidemia
• Intervention / Treatment: Drug: Escitalopram plus atorvastatin

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• China
  • Hebei
    • Hengshui, Hebei, China, 053800
      • Hengshui City Seventh People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study population consists of patients aged 18-65 years diagnosed with depressive episode (ICD-10) combined with mild-to-moderate dyslipidemia. Subjects with HAMD-17 total score ≥17 at admission, complete clinical data and willingness to complete 4-week follow-up are enrolled. Patients with severe organic diseases, other psychiatric disorders, drug allergies, recent use of statins or antidepressants, substance abuse, concurrent trials, pregnancy or lactation are excluded.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Drug: Escitalopram plus atorvastatin; Patients with depressive episode and dyslipidemia receive standard oral escitalopram combined with atorvastatin as routine clinical treatment.
Escitalopram monotherapy control group; Patients receive only escitalopram monotherapy as the control group to compare clinical indicators with the combined medication group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in total score of the 17-item Hamilton Depression Rating Scale (HAMD-17)	4 weeks after baseline enrollment

Collaborators and Investigators

• Sponsor: Hengshui City Seventh People's Hospital
• Investigators: Principal Investigator: bei bei zhang, Bachelor's degree, Hengshui City Seventh People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2025
• Primary Completion (Actual): May 10, 2026
• Study Completion (Actual): May 27, 2026

Study Registration Dates

• First Submitted: July 14, 2026
• First Submitted That Met QC Criteria: July 14, 2026
• First Posted (Actual): July 17, 2026

Study Record Updates

• Last Update Posted (Actual): July 17, 2026
• Last Update Submitted That Met QC Criteria: July 14, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Nutritional and Metabolic Diseases; Dyslipidemias; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Fatty Acids; Lipids; Azoles; Amines; Nitriles; Pyrroles; Heptanoic Acids; Propylamines; Benzofurans; Atorvastatin; Escitalopram
• Other Study ID Numbers: 2025002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No