Depressive Episode, DyslipidemiaNCT07712367
Atorvastatin Plus Escitalopram for Depression With Dyslipidemia
An observational study of Depressive Episode, Dyslipidemia, run by Hengshui City Seventh People's Hospital at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depressive Episode, Dyslipidemia
- What is being tested?
- Escitalopram plus atorvastatin
- Type of treatment
- Pill or oral medicine
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2025to 27 May 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Depressive Episode, Dyslipidemia
- Being tested
- Escitalopram plus atorvastatin
- Medical subject headings
- Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Escitalopram plus atorvastatinDrug
Patients with depressive episode and dyslipidemia receive standard oral escitalopram combined with atorvastatin as routine clinical treatment.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Escitalopram plus atorvastatin | |
| Escitalopram monotherapy control group | Patients receive only escitalopram monotherapy as the control group to compare clinical indicators with the combined medication group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in total score of the 17-item Hamilton Depression Rating Scale (HAMD-17)
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.
Measured: 4 weeks after baseline enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2026
- Study start1 Sep 2025
- Primary completion10 May 2026
- Study completion27 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive Episode, DyslipidemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hengshui City Seventh People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhang Beibei, Hengshui City Seventh People's Hospital
- Investigators
- bei bei zhang, Bachelor's degree, Principal investigator, Hengshui City Seventh People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07712367
- Sponsor's protocol ID
- 2025002
- Status last verified
- Jul 2026
- First submitted
- 14 Jul 2026
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observation on Efficacy and Safety of Atorvastatin Combined With Escitalopram in Patients With Depressive Episode Complicated by Dyslipidemia
- ClinicalTrials.gov ID
- NCT07712367
- Acronym / sponsor ID
- 2025002
- Conditions
- Depressive Episode, Dyslipidemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Hengshui City Seventh People's HospitalUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 10 May 2026 (actual)
- Study completion
- 27 May 2026 (actual)
- First posted
- 17 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Escitalopram plus atorvastatin combination group | – | Drug: Escitalopram plus atorvastatinParticipants take routine escitalopram and atorvastatin simultaneously to treat depressive episode and dyslipidemia. Follow-up data are collected to observe therapeutic effect and adverse reactions. |
| Escitalopram monotherapy control group | – | –Patients receive only escitalopram monotherapy as the control group to compare clinical indicators with the combined medication group. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Escitalopram plus atorvastatinPatients with depressive episode and dyslipidemia receive standard oral escitalopram combined with atorvastatin as routine clinical treatment. | Drug | Escitalopram plus atorvastatin combination group |
Primary outcome
Change in total score of the 17-item Hamilton Depression Rating Scale (HAMD-17)
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
- Individual participant dataSharing planned: No. 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
bei bei zhang, Bachelor's degree principal investigator
Hengshui City Seventh People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depressive Episode, Dyslipidemia, run by Hengshui City Seventh People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in total score of the 17-item Hamilton Depression Rating Scale (HAMD-17) (time frame: 4 weeks after baseline enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2026.