SchizophreniaPhase 3NCT07045142
Metformin Alleviates Abnormal Glucose Metabolism Induced by Statins in Schizophrenia Patients
A Phase 3 study testing Atorvastatin and Metformin in people with Schizophrenia, run by Central South University at 8 sites in China.
Trial summary
Schizophrenia is a severe mental illness associated with significant morbidity and disability. Patients often experience metabolic side effects from antipsychotic medications, including weight gain and dyslipidemia. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Atorvastatin and Metformin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 400 participants
- Where
- 8 sitesChina
- Study dates
- 1 Jul 2025to 1 Jun 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Aged between 18 and 65 years, regardless of gender, and meets the diagnostic criteria for schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5);
- Symptoms and medication regimen stable for more than 3 months, with the allowance of up to two antipsychotic medications in combination (concurrent use of antidepressants, anxiolytics, and mood stabilizers is permitted);
- Temporary use of benzodiazepines is allowed;
- Meets at least one of the following conditions: fasting total cholesterol (TC) ≥ 5.2 mmol/L; fasting triglycerides (TG) ≥ 1.7 mmol/L; fasting low-density lipoprotein cholesterol (LDL-C) ≥ 3.4 mmol/L;
- Two fasting blood glucose (FPG) tests must be < 6.1 mmol/L (with an interval of 1-4 weeks);
- It is anticipated that there will be no issues related to relocation, transportation difficulties, or access to medical care throughout the study;
- Informed consent must be obtained from the patient and their guardian, and a consent form must be signed.
Who cannot join
- Patients with a prior diagnosis of diabetes or complications such as diabetic ketoacidosis;
- Patients with liver or kidney dysfunction, indicated by aspartate aminotransferase (AST), alanine aminotransferase (ALT), or gamma-glutamyl transferase (GGT) levels exceeding twice the normal limits, and/or creatinine levels exceeding 1.2 times the upper limit of the reference range or greater than 2 mg/dL, or deemed by the investigator to have liver and/or kidney impairment that warrants exclusion from the study;
- Patients with severe gastrointestinal, respiratory, endocrine, hematologic diseases, or metabolic absorption disorders: including but not limited to poorly controlled diabetes, severe acute systemic infections or immunological diseases, ischemic heart disease, cerebrovascular accidents within the past year, history of prolonged QT interval, active hepatitis B virus, chronic active hepatitis C, and malabsorption syndromes;
- Clinically significant abnormal ECG findings at screening that the investigator deems unsuitable for inclusion, such as male QTc interval > 470 ms, female QTc interval > 480 ms;
- Pregnant or nursing women.
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
China8 sites, 2 recruiting
- Recruiting
Mental Health Institute of Second Xiangya Hospital, CSU
Changsha, Hunan
Renrong Wu, 15874179855, wurenrong@csu.edu.cn
Xinyi Zhao, +86 17803908545, 852646662@qq.com
- Active, not recruiting
The Third Hospital of Changsha County
Changsha, Hunan
- Completed
The Second People's Hospital of Dali Bai Autonomous Prefecture
Dali, Yunnan
- Active, not recruiting
Xiangshan County Traditional Chinese Medicine Hospital Medical and Health Group Three Hospitals District
Xiangshan, Zhejiang, 315799
- Active, not recruiting
The Second People's Hospital of Xiangyin County
Yueyang, Hunan, 410500
- Active, not recruiting
Junshan District Psychiatric Rehabilitation Hospital
Yueyang, Hunan, 414000
- Recruiting
Yueyang Rehabilitation Hospital
Yueyang, Hunan, 414022
Gaoyong Fang, 8615274053677, 1048534957@qq.com
- Active, not recruiting
Zhumadian Second People's Hospital
Zhumadian, Henan
About this study
Official title: Metformin Alleviates Abnormal Glucose Metabolism Induced by Statins in Schizophrenia Patients: A Randomized, Double-Blind, Placebo-Controlled Multicenter Clinical Study
Schizophrenia is a severe mental illness associated with significant morbidity and disability. Patients often experience metabolic side effects from antipsychotic medications, including weight gain and dyslipidemia. Statins, commonly used to manage dyslipidemia, can lower cholesterol levels but may increase the risk of new-onset diabetes.
This study aims to investigate how atorvastatin affects glucose metabolism in schizophrenia patients and assess whether metformin can help improve these metabolic issues. The investigators will include 200 patients with dyslipidemia from the Second Xiangya Hospital and other sites, randomly assigning them to receive either atorvastatin with metformin or atorvastatin with placebo over six months.
Read more
Key goals include evaluating the impact of atorvastatin on insulin resistance and blood glucose levels and determining the effectiveness of metformin in mitigating glucose metabolism abnormalities while managing lipid levels.
Understanding these interactions will help improve treatment strategies for schizophrenia patients, potentially lowering their risk of cardiovascular diseases and diabetes and enhancing overall health outcomes.
Read the detailed description
Research Background: Schizophrenia is a severe mental disorder characterized by high morbidity, significant disability, and substantial disease burden. Studies have shown that antipsychotic medications, particularly atypical antipsychotics, can lead to considerable metabolic side effects, including weight gain, hyperlipidemia, hyperglycemia, and insulin resistance. Statins are widely used for cardiovascular disease prevention and treatment in high-risk populations. Schizophrenia patients are at an increased risk of dyslipidemia due to long-term antipsychotic medication use, with research indicating that approximately 66% of chronic schizophrenia patients develop varying degrees of dyslipidemia following antipsychotic treatment. Dyslipidemia not only accelerates cardiovascular disease progression but may also lead to premature mortality, with schizophrenia patients facing double the risk of cardiovascular death compared to the general population, resulting in a reduction of lifespan by 9 to 12 years. As such, monitoring and intervening in dyslipidemia among these patients are crucial for improving long-term prognosis. However, while long-term statin use can mitigate myocardial infarction risk, it also raises the risk of new-onset diabetes, with evidence suggesting a 10% increase in diabetes risk attributable to statins-a factor that has not been thoroughly examined in the context of glucose metabolism in schizophrenia patients.
Research Objective: This study aims to explore the occurrence of glucose metabolism abnormalities in schizophrenia patients undergoing atorvastatin treatment for dyslipidemia and to evaluate the ameliorative effects of metformin. Specific objectives include: 1) Investigating the impact of atorvastatin on glucose metabolism by observing changes in insulin resistance, fasting blood glucose, and glycated hemoglobin levels to assess atorvastatin's potential effects on glucose metabolism; 2) Evaluating the adjunctive role of metformin by randomly assigning eligible patients to either a metformin treatment group or a placebo group to observe the auxiliary effect of metformin in atorvastatin therapy and assess its impact on glucose metabolism abnormalities and underlying mechanisms; and 3) Examining the metabolic effects of metformin on dyslipidemia by assessing its influence on lipid profiles (e.g., LDL-C, total cholesterol, triglycerides) during atorvastatin treatment while controlling for glucose metabolism abnormalities.
Research Plan: This study will recruit 200 schizophrenia patients from the Second Xiangya Hospital of Central South University and other partnering institutions. Eligible participants must be aged 18 to 65, meet the criteria for schizophrenia, have stable symptoms and medication regimens for over three months. Participants will provide informed consent prior to inclusion. For lipid levels, participants must meet at least one of the following criteria: 1) fasting total cholesterol (TC) ≥ 5.2 mmol/L; 2) fasting triglycerides (TG) ≥ 1.7 mmol/L; 3) fasting low-density lipoprotein cholesterol (LDL-C) ≥ 3.4 mmol/L. For blood glucose, participants must have two consecutive fasting blood glucose (FPG) tests < 6.1 mmol/L, with an interval of 1-4 weeks between tests. Patients with a prior diagnosis of diabetes, diabetic ketoacidosis, or any other diabetes-related complications are excluded. Participants will provide informed consent prior to inclusion. The study employs a randomized controlled trial (RCT) design, with participants randomly assigned to two groups: one group receiving atorvastatin 20 mg/day combined with metformin 1000 mg/day and the other receiving atorvastatin 20 mg/day with a placebo. The study duration is six months, with follow-ups at 3 and 6 months, including baseline assessments and multiple blood tests to monitor glucose metabolism and other relevant indices.
Expected Outcomes: By evaluating the effects of atorvastatin on glucose metabolism in schizophrenia patients and the intervention effects of metformin, this study seeks to elucidate the risk of glucose metabolism abnormalities associated with statin therapy in this population and the mechanisms through which metformin improves these outcomes. This research will contribute to developing more effective treatment regimens for schizophrenia patients, thereby reducing cardiovascular disease and diabetes risks and improving patient prognosis. Additionally, results may facilitate the integration of management practices for both mental and metabolic disorders, reducing the healthcare burden from metabolic complications.
- Conditions
- Schizophrenia
- Being tested
- Atorvastatin, Metformin, Placebo
- Keywords
- Schizophrenia, Dyslipidemia, Metformin, Statin
- Medical subject headings
- Schizophrenia, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtorvastatinDrug
Participants will receive atorvastatin 20 mg daily.
MetforminDrug
Participants will receive metformin 1000 mg daily.
PlaceboDrug
Participants will receive placebo 1000 mg daily, mimicking the appearance of metformin without containing active ingredients.
| Study group | Role | What they receive |
|---|---|---|
| Metformin group | Active comparator | To explore the impact of metformin on glucose metabolism abnormalities in schizophrenia patients undergoing atorvastatin treatment. Receives: Drug: Atorvastatin; Drug: Metformin |
| Placebo group | Placebo comparator | To serve as a placebo control for evaluating the effects of atorvastatin treatment on glucose metabolism in schizophrenia patients, isolating the impact of metformin from the effects of atorvastatin. Receives: Drug: Atorvastatin; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Fasting Blood Glucose Concentration
Measured: Baseline, 3rd month, 6th month
Change from Baseline in Glycated Hemoglobin (HbA1c) Concentration
Measured: Baseline, 3rd month, 6th month
Oral Glucose Tolerance Test
The Oral Glucose Tolerance Test (OGTT) requires subjects to undergo an 8-hour fasting period, followed by an initial measurement of fasting blood glucose via a portable glucometer using a finger prick. Subsequently, subjects are instructed to consume a solution containing 75 grams of anhydrous glucose dissolved in 300 milliliters of water. Blood samples are then collected through finger pricking at 1 hour and 2 hours post-ingestion for further analysis of glucose levels.
Measured: Baseline, 3rd month, 6th month
Secondary outcomes (6)
Change from Baseline in Fasting insulin Concentration
Measured: Baseline, 3rd month, 6th month
Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)
HOMA-IR (Homeostasis Model Assessment of Insulin Resistance) is a recognized method for estimating insulin resistance, which plays a critical role in metabolic disorders such as type 2 diabetes and cardiovascular disease. This assessment requires fasting for at least eight hours, followed by the measurement of fasting insulin and fasting glucose levels from blood samples. The HOMA-IR value indicates the degree of insulin resistance; higher values suggest reduced cellular responsiveness to insulin, thereby correlating with increased risk for metabolic syndrome and type 2 diabetes.
Measured: Baseline, 3rd month, 6th month
Change from Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score
Range: 30 to 210; Higher Scores Indicate Worse Symptoms.
Measured: Baseline, 3rd month, 6th month
Change from Baseline in Global Assessment of Functioning Scale (GAF) Total Score
Range: 0 to 100; Higher Scores Indicate Better Functioning.
Measured: Baseline, 3rd month, 6th month
Abdominal ultrasound examination.
Abdominal ultrasound is performed only at designated study sites and serves as a secondary outcome.The abdominal ultrasound examination will focus on assessing the occurrence of metabolic associated fatty liver disease (MAFLD). Subjects are required to fast for at least 8 hours prior to the examination, and they will lie supine on the examination table. After applying a coupling agent, an ultrasound scan will be performed. The physician will measure the size of the liver, observe its echo characteristics, and assess the echo differences with surrounding organs to determine the presence of liver enlargement or fat deposition. MAFLD typically presents as increased hepatic echogenicity and blurred liver margins. Doppler ultrasound may also be used to evaluate hepatic blood flow if necessary. All examination results will be recorded on case report forms for comprehensive analysis to assess the metabolic status and the degree of MAFLD in the study subjects.
Measured: baseline, 6 months
Glycated Albumin (GA)
Measured: Baseline, 3rd month, 6th month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2025
- Study start1 Jul 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion1 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- We will include 200-400 schizophrenia patients with dyslipidemia from the Second Xiangya Hospital and other sites, randomly assigning them to receive either atorvastatin with metformin or atorvastatin with placebo. Two groups were observed longitudinally for 6 months.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central South University
- Sponsor type
- University, hospital or other
- Collaborators
- Zhumadian Second People's Hospital, Changsha Third Hospital, The Second People's Hospital of Dali Bai Autonomous Prefecture, Xiangshan County Traditional Chinese Medicine Hospital Medical and Health Group Three Hospitals Distric, Yueyang Rehabilitation Hospital, Junshan District Psychiatric Rehabilitation Hospital, The Second People's Hospital of Xiangyin County
- Responsible party
- Principal investigator, Renrong Wu, Central South University
- Investigators
- Renrong Wu, Study chair, Mental Health Institute of Second Xiangya Hospital,CSU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07045142
- Sponsor's protocol ID
- WU202505STA
- Status last verified
- Mar 2026
- First submitted
- 22 Jun 2025
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Sasaki J, Otonari T, Uchida Y, Ikeda Y, Biro S, Kono S; PRAT study investigators. Effects of pravastatin and atorvastatin on HDL cholesterol and glucose metabolism in patients with dyslipidemia and glucose intolerance: the PRAT study. J Atheroscler Thromb. 2013;20(4):368-79. doi: 10.5551/jat.13532. Epub 2012 Dec 15.
PubMed 23257975Preiss D, Seshasai SR, Welsh P, Murphy SA, Ho JE, Waters DD, DeMicco DA, Barter P, Cannon CP, Sabatine MS, Braunwald E, Kastelein JJ, de Lemos JA, Blazing MA, Pedersen TR, Tikkanen MJ, Sattar N, Ray KK. Risk of incident diabetes with intensive-dose compared with moderate-dose statin therapy: a meta-analysis. JAMA. 2011 Jun 22;305(24):2556-64. doi: 10.1001/jama.2011.860.
PubMed 21693744Sattar N, Preiss D, Murray HM, Welsh P, Buckley BM, de Craen AJ, Seshasai SR, McMurray JJ, Freeman DJ, Jukema JW, Macfarlane PW, Packard CJ, Stott DJ, Westendorp RG, Shepherd J, Davis BR, Pressel SL, Marchioli R, Marfisi RM, Maggioni AP, Tavazzi L, Tognoni G, Kjekshus J, Pedersen TR, Cook TJ, Gotto AM, Clearfield MB, Downs JR, Nakamura H, Ohashi Y, Mizuno K, Ray KK, Ford I. Statins and risk of incident diabetes: a collaborative meta-analysis of randomised statin trials. Lancet. 2010 Feb 27;375(9716):735-42. doi: 10.1016/S0140-6736(09)61965-6. Epub 2010 Feb 16.
PubMed 20167359Pillinger T, McCutcheon RA, Vano L, Mizuno Y, Arumuham A, Hindley G, Beck K, Natesan S, Efthimiou O, Cipriani A, Howes OD. Comparative effects of 18 antipsychotics on metabolic function in patients with schizophrenia, predictors of metabolic dysregulation, and association with psychopathology: a systematic review and network meta-analysis. Lancet Psychiatry. 2020 Jan;7(1):64-77. doi: 10.1016/S2215-0366(19)30416-X. Epub 2019 Dec 17.
PubMed 31860457
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metformin Alleviates Abnormal Glucose Metabolism Induced by Statins in Schizophrenia Patients: A Randomized, Double-Blind, Placebo-Controlled Multicenter Clinical Study
- ClinicalTrials.gov ID
- NCT07045142
- Acronym / sponsor ID
- WU202505STA
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia, Dyslipidemia, Metformin, Statin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Central South UniversityUniversity, hospital or other
- Collaborators
- Zhumadian Second People's Hospital, Changsha Third Hospital, The Second People's Hospital of Dali Bai Autonomous Prefecture, Xiangshan County Traditional Chinese Medicine Hospital Medical and Health Group Three Hospitals Distric, Yueyang Rehabilitation Hospital, Junshan District Psychiatric Rehabilitation Hospital, The Second People's Hospital of Xiangyin County
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 1 Jun 2028 (estimated)
- First posted
- 1 Jul 2025 (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.
Schizophrenia is a severe mental illness associated with significant morbidity and disability. Patients often experience metabolic side effects from antipsychotic medications, including weight gain and dyslipidemia. Statins, commonly used to manage dyslipidemia, can lower cholesterol levels but may increase the risk of new-onset diabetes.
This study aims to investigate how atorvastatin affects glucose metabolism in schizophrenia patients and assess whether metformin can help improve these metabolic issues. The investigators will include 200 patients with dyslipidemia from the Second Xiangya Hospital and other sites, randomly assigning them to receive either atorvastatin with metformin or atorvastatin with placebo over six months.
Key goals include evaluating the impact of atorvastatin on insulin resistance and blood glucose levels and determining the effectiveness of metformin in mitigating glucose metabolism abnormalities while managing lipid levels.
Understanding these interactions will help improve treatment strategies for schizophrenia patients, potentially lowering their risk of cardiovascular diseases and diabetes and enhancing overall health outcomes.
Detailed description
Research Background: Schizophrenia is a severe mental disorder characterized by high morbidity, significant disability, and substantial disease burden. Studies have shown that antipsychotic medications, particularly atypical antipsychotics, can lead to considerable metabolic side effects, including weight gain, hyperlipidemia, hyperglycemia, and insulin resistance. Statins are widely used for cardiovascular disease prevention and treatment in high-risk populations. Schizophrenia patients are at an increased risk of dyslipidemia due to long-term antipsychotic medication use, with research indicating that approximately 66% of chronic schizophrenia patients develop varying degrees of dyslipidemia following antipsychotic treatment. Dyslipidemia not only accelerates cardiovascular disease progression but may also lead to premature mortality, with schizophrenia patients facing double the risk of cardiovascular death compared to the general population, resulting in a reduction of lifespan by 9 to 12 years. As such, monitoring and intervening in dyslipidemia among these patients are crucial for improving long-term prognosis. However, while long-term statin use can mitigate myocardial infarction risk, it also raises the risk of new-onset diabetes, with evidence suggesting a 10% increase in diabetes risk attributable to statins-a factor that has not been thoroughly examined in the context of glucose metabolism in schizophrenia patients.
Research Objective: This study aims to explore the occurrence of glucose metabolism abnormalities in schizophrenia patients undergoing atorvastatin treatment for dyslipidemia and to evaluate the ameliorative effects of metformin. Specific objectives include: 1) Investigating the impact of atorvastatin on glucose metabolism by observing changes in insulin resistance, fasting blood glucose, and glycated hemoglobin levels to assess atorvastatin's potential effects on glucose metabolism; 2) Evaluating the adjunctive role of metformin by randomly assigning eligible patients to either a metformin treatment group or a placebo group to observe the auxiliary effect of metformin in atorvastatin therapy and assess its impact on glucose metabolism abnormalities and underlying mechanisms; and 3) Examining the metabolic effects of metformin on dyslipidemia by assessing its influence on lipid profiles (e.g., LDL-C, total cholesterol, triglycerides) during atorvastatin treatment while controlling for glucose metabolism abnormalities.
Research Plan: This study will recruit 200 schizophrenia patients from the Second Xiangya Hospital of Central South University and other partnering institutions. Eligible participants must be aged 18 to 65, meet the criteria for schizophrenia, have stable symptoms and medication regimens for over three months. Participants will provide informed consent prior to inclusion. For lipid levels, participants must meet at least one of the following criteria: 1) fasting total cholesterol (TC) ≥ 5.2 mmol/L; 2) fasting triglycerides (TG) ≥ 1.7 mmol/L; 3) fasting low-density lipoprotein cholesterol (LDL-C) ≥ 3.4 mmol/L. For blood glucose, participants must have two consecutive fasting blood glucose (FPG) tests < 6.1 mmol/L, with an interval of 1-4 weeks between tests. Patients with a prior diagnosis of diabetes, diabetic ketoacidosis, or any other diabetes-related complications are excluded. Participants will provide informed consent prior to inclusion. The study employs a randomized controlled trial (RCT) design, with participants randomly assigned to two groups: one group receiving atorvastatin 20 mg/day combined with metformin 1000 mg/day and the other receiving atorvastatin 20 mg/day with a placebo. The study duration is six months, with follow-ups at 3 and 6 months, including baseline assessments and multiple blood tests to monitor glucose metabolism and other relevant indices.
Expected Outcomes: By evaluating the effects of atorvastatin on glucose metabolism in schizophrenia patients and the intervention effects of metformin, this study seeks to elucidate the risk of glucose metabolism abnormalities associated with statin therapy in this population and the mechanisms through which metformin improves these outcomes. This research will contribute to developing more effective treatment regimens for schizophrenia patients, thereby reducing cardiovascular disease and diabetes risks and improving patient prognosis. Additionally, results may facilitate the integration of management practices for both mental and metabolic disorders, reducing the healthcare burden from metabolic complications.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- We will include 200-400 schizophrenia patients with dyslipidemia from the Second Xiangya Hospital and other sites, randomly assigning them to receive either atorvastatin with metformin or atorvastatin with placebo. Two groups were observed longitudinally for 6 months.
| Arm | Type | Receives |
|---|---|---|
| Metformin group | Active comparator | Drug: Atorvastatin, Drug: MetforminTo explore the impact of metformin on glucose metabolism abnormalities in schizophrenia patients undergoing atorvastatin treatment. |
| Placebo group | Placebo comparator | Drug: Atorvastatin, Drug: PlaceboTo serve as a placebo control for evaluating the effects of atorvastatin treatment on glucose metabolism in schizophrenia patients, isolating the impact of metformin from the effects of atorvastatin. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Aged between 18 and 65 years, regardless of gender, and meets the diagnostic criteria for schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5);
- Symptoms and medication regimen stable for more than 3 months, with the allowance of up to two antipsychotic medications in combination (concurrent use of antidepressants, anxiolytics, and mood stabilizers is permitted);
- Temporary use of benzodiazepines is allowed;
- Meets at least one of the following conditions: fasting total cholesterol (TC) ≥ 5.2 mmol/L; fasting triglycerides (TG) ≥ 1.7 mmol/L; fasting low-density lipoprotein cholesterol (LDL-C) ≥ 3.4 mmol/L;
- Two fasting blood glucose (FPG) tests must be < 6.1 mmol/L (with an interval of 1-4 weeks);
Key exclusion criteria (5 listed)
- Patients with a prior diagnosis of diabetes or complications such as diabetic ketoacidosis;
- Patients with liver or kidney dysfunction, indicated by aspartate aminotransferase (AST), alanine aminotransferase (ALT), or gamma-glutamyl transferase (GGT) levels exceeding twice the normal limits, and/or creatinine levels exceeding 1.2 times the upper limit of the reference range or greater than 2 mg/dL, or deemed by the investigator to have liver and/or kidney impairment that warrants exclusion from the study;
- Patients with severe gastrointestinal, respiratory, endocrine, hematologic diseases, or metabolic absorption disorders: including but not limited to poorly controlled diabetes, severe acute systemic infections or immunological diseases, ischemic heart disease, cerebrovascular accidents within the past year, history of prolonged QT interval, active hepatitis B virus, chronic active hepatitis C, and malabsorption syndromes;
- Clinically significant abnormal ECG findings at screening that the investigator deems unsuitable for inclusion, such as male QTc interval > 470 ms, female QTc interval > 480 ms;
- Pregnant or nursing 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 |
|---|---|---|
| AtorvastatinParticipants will receive atorvastatin 20 mg daily. | Drug | Metformin group, Placebo group |
| MetforminParticipants will receive metformin 1000 mg daily. | Drug | Metformin group |
| PlaceboParticipants will receive placebo 1000 mg daily, mimicking the appearance of metformin without containing active ingredients. | Drug | Placebo group |
Primary outcome
Change from Baseline in Fasting Blood Glucose Concentration
Time frame: Baseline, 3rd month, 6th month
Change from Baseline in Glycated Hemoglobin (HbA1c) Concentration
Time frame: Baseline, 3rd month, 6th month
Oral Glucose Tolerance Test
Time frame: Baseline, 3rd month, 6th month
The Oral Glucose Tolerance Test (OGTT) requires subjects to undergo an 8-hour fasting period, followed by an initial measurement of fasting blood glucose via a portable glucometer using a finger prick. Subsequently, subjects are instructed to consume a solution containing 75 grams of anhydrous glucose dissolved in 300 milliliters of water. Blood samples are then collected through finger pricking at 1 hour and 2 hours post-ingestion for further analysis of glucose levels.
6 secondary outcomes
Change from Baseline in Fasting insulin Concentration
Time frame: Baseline, 3rd month, 6th month
Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)
Time frame: Baseline, 3rd month, 6th month
Change from Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score
Time frame: Baseline, 3rd month, 6th month
Change from Baseline in Global Assessment of Functioning Scale (GAF) Total Score
Time frame: Baseline, 3rd month, 6th month
Abdominal ultrasound examination.
Time frame: baseline, 6 months
Glycated Albumin (GA)
Time frame: Baseline, 3rd month, 6th month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
- Results publication: PubMed 23257975Sasaki J, Otonari T, Uchida Y, Ikeda Y, Biro S, Kono S; PRAT study investigators. Effects of pravastatin and atorvastatin on HDL cholesterol and glucose metabolism in patients with dyslipidemia and glucose intolerance: the PRAT study. J Atheroscler Thromb. 2013;20(4):368-79. doi: 10.5551/jat.13532. Epub 2012 Dec 15.
- Results publication: PubMed 21693744Preiss D, Seshasai SR, Welsh P, Murphy SA, Ho JE, Waters DD, DeMicco DA, Barter P, Cannon CP, Sabatine MS, Braunwald E, Kastelein JJ, de Lemos JA, Blazing MA, Pedersen TR, Tikkanen MJ, Sattar N, Ray KK. Risk of incident diabetes with intensive-dose compared with moderate-dose statin therapy: a meta-analysis. JAMA. 2011 Jun 22;305(24):2556-64. doi: 10.1001/jama.2011.860.
- Results publication: PubMed 20167359Sattar N, Preiss D, Murray HM, Welsh P, Buckley BM, de Craen AJ, Seshasai SR, McMurray JJ, Freeman DJ, Jukema JW, Macfarlane PW, Packard CJ, Stott DJ, Westendorp RG, Shepherd J, Davis BR, Pressel SL, Marchioli R, Marfisi RM, Maggioni AP, Tavazzi L, Tognoni G, Kjekshus J, Pedersen TR, Cook TJ, Gotto AM, Clearfield MB, Downs JR, Nakamura H, Ohashi Y, Mizuno K, Ray KK, Ford I. Statins and risk of incident diabetes: a collaborative meta-analysis of randomised statin trials. Lancet. 2010 Feb 27;375(9716):735-42. doi: 10.1016/S0140-6736(09)61965-6. Epub 2010 Feb 16.
- Results publication: PubMed 31860457Pillinger T, McCutcheon RA, Vano L, Mizuno Y, Arumuham A, Hindley G, Beck K, Natesan S, Efthimiou O, Cipriani A, Howes OD. Comparative effects of 18 antipsychotics on metabolic function in patients with schizophrenia, predictors of metabolic dysregulation, and association with psychopathology: a systematic review and network meta-analysis. Lancet Psychiatry. 2020 Jan;7(1):64-77. doi: 10.1016/S2215-0366(19)30416-X. Epub 2019 Dec 17.
- Individual participant dataSharing planned: Yes
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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.
Renrong Wu study chair
Mental Health Institute of Second Xiangya Hospital,CSU
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Atorvastatin and Metformin in people with Schizophrenia, run by Central South University at 8 sites 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 7 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: looking for participants now, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jing Huang (+86 15874290980, jinghuangserena@csu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Fasting Blood Glucose Concentration (time frame: Baseline, 3rd month, 6th month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07045142, which also lists 4 linked publications.
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 3 Aug 2026.