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Atorvastatin Plus Escitalopram for Depression With Dyslipidemia

17 de julio de 2026 actualizado por: Zhang Beibei, Hengshui City Seventh People's Hospital

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.

Descripción general del estudio

Estado

Terminado

Intervención / Tratamiento

Descripción detallada

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.

Tipo de estudio

De observación

Inscripción (Actual)

60

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

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

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Método de muestreo

Muestra no probabilística

Población de estudio

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.

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Cohortes e Intervenciones

Grupo / Cohorte
Intervención / Tratamiento
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.
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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in total score of the 17-item Hamilton Depression Rating Scale (HAMD-17)
Periodo de tiempo: 4 weeks after baseline enrollment
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.
4 weeks after baseline enrollment

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

  • Investigador principal: bei bei zhang, Bachelor's degree, Hengshui City Seventh People's Hospital

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

1 de septiembre de 2025

Finalización primaria (Actual)

10 de mayo de 2026

Finalización del estudio (Actual)

27 de mayo de 2026

Fechas de registro del estudio

Enviado por primera vez

14 de julio de 2026

Primero enviado que cumplió con los criterios de control de calidad

14 de julio de 2026

Publicado por primera vez (Actual)

17 de julio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

21 de julio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

17 de julio de 2026

Última verificación

1 de julio de 2026

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Descripción del plan IPD

  1. Raw data contains sensitive personal medical information of patients with depressive disorder, and data sharing may lead to privacy leakage of subjects.
  2. This is not an academic degree research, and there is no pre-arranged data sharing mechanism for external investigators.
  3. 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.

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

Sí

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

producto fabricado y exportado desde los EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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