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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Tipo de estudo
Inscrição (Real)
Contactos e Locais
Locais de estudo
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Hebei
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Hengshui, Hebei, China, 053800
- Hengshui City Seventh People's Hospital
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Método de amostragem
População do estudo
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
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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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change in total score of the 17-item Hamilton Depression Rating Scale (HAMD-17)
Prazo: 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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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: bei bei zhang, Bachelor's degree, Hengshui City Seventh People's Hospital
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
- Doenças Metabólicas
- Distúrbios do metabolismo lipídico
- Doenças Nutricionais e Metabólicas
- Dislipidemias
- Produtos químicos orgânicos
- Compostos heterocíclicos, 1 anel
- Compostos heterocíclicos
- Compostos heterocíclicos, 2 anel
- Compostos heterocíclicos, anel fundido
- Ácidos graxos
- Lipídios
- Azoles
- Aminas
- Nitrilos
- Pirróis
- Ácidos heptanóicos
- Propilaminas
- Benzofuranos
- Atorvastatina
- Escitalopram
Outros números de identificação do estudo
- 2025002
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
- 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.
Informações sobre medicamentos e dispositivos, documentos de estudo
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