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.
연구 개요
상세 설명
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Hebei
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Hengshui, Hebei, 중국, 053800
- Hengshui City Seventh People's Hospital
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
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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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
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Change in total score of the 17-item Hamilton Depression Rating Scale (HAMD-17)
기간: 4 weeks after baseline enrollment
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4 weeks after baseline enrollment
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공동 작업자 및 조사자
수사관
- 수석 연구원: bei bei zhang, Bachelor's degree, Hengshui City Seventh People's Hospital
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 2025002
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
- 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.
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
미국에서 제조되어 미국에서 수출되는 제품
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
Escitalopram plus atorvastatin에 대한 임상 시험
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Qure Healthcare, LLCLineagen완전한
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University of NottinghamNational Institute for Health Research, United Kingdom모병
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Fayoum University아직 모집하지 않음
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Istituto Clinico Humanitas Mater Domini아직 모집하지 않음
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Pacific Edge Limited모병