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Atorvastatin Plus Escitalopram for Depression With Dyslipidemia

14. juli 2026 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

60

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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.

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
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.
Medicin: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Change in total score of the 17-item Hamilton Depression Rating Scale (HAMD-17)
Tidsramme: 4 weeks after baseline enrollment
4 weeks after baseline enrollment

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Hengshui City Seventh People's Hospital

Efterforskere

  • Ledende efterforsker: bei bei zhang, Bachelor's degree, Hengshui City Seventh People's Hospital

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. september 2025

Primær færdiggørelse (Faktiske)

10. maj 2026

Studieafslutning (Faktiske)

27. maj 2026

Datoer for studieregistrering

Først indsendt

14. juli 2026

Først indsendt, der opfyldte QC-kriterier

14. juli 2026

Først opslået (Faktiske)

17. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

17. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

14. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2025002

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

  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.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

produkt fremstillet i og eksporteret fra U.S.A.

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Depressive Episode, Dyslipidemia

Kliniske forsøg med Escitalopram plus atorvastatin

Søg i lignende forsøg

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Betingelser

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Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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