A Phase 3 interventional study of Atorvastatin and Metformin in Schizophrenia, sponsored by Central South University. Recruiting at 8 sites in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-08-03.
Sponsored by Central South University · Phase 3, Interventional, and Prevention
Among 13 studies testing metformin in Schizophrenia — 1 open to participants now, 1 under way, 1 of them phase 3. Metformin · Schizophrenia.
Among the 13 studies testing metformin in Schizophrenia, this one has the largest planned enrollment, is the only one that started in 2025, is the only one in phase 3, and was the 13th registered.
3,563 studies on the registry are indexed under Schizophrenia; 491 are open to participants now.
This study's planned enrollment of 400 is above the median of 71 across 2,944 interventional studies indexed under Schizophrenia.
Browse Schizophrenia studies →1 of the 13 studies testing metformin in Schizophrenia is open now, in 1 country. Each count lists the studies.
Metformin: first FDA approval 1995 (GLUCOPHAGE), first EMA approval 2003. What it is approved for, and how studies give it, is on its page →
Of the 331 Schizophrenia studies recruiting now, 63 (19%) set no upper age limit and 257 (78%) stop at 75 or younger; 42 take children under 18; 83 take healthy volunteers.
This study: 18 Years to 65 Years · all sexes · no healthy volunteers.
The full table on the hub →13 studies; the count open now beside each. This study's row is marked.
First in 2006; this study’s year is marked. 1 started in 2025.
Median enrollment 55 across the 13 interventional studies. Of the 10 that completed or were terminated, 5 (50%) have results posted.
None of the 13 has an industry lead sponsor. The 10 most frequent:
Central South University is the lead sponsor of 134 studies on the registry; 32 are open to participants now.
33 studies in Schizophrenia by Central South University: 10 open now, 10 under way, 1 of them phase 3. Of 14 finished, 0 (0%) have results posted.
Among the 33 studies in Schizophrenia by Central South University, this one is the 2nd largest by planned enrollment of the 27 interventional ones, is one of 2 that started in 2025, is one of 2 in phase 3, and was the 27th registered.
Central South University’s Schizophrenia studies by the year they started, since 2003.
None of the studies under way reaches primary completion within a year.
Among the 13 studies testing metformin in Schizophrenia, from their registry updates:
Nothing recorded among them since 2026-09-25.
Among Central South University’s 33 in Schizophrenia:
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
To explore the impact of metformin on glucose metabolism abnormalities in schizophrenia patients undergoing atorvastatin treatment.
Drug: Atorvastatin · Drug: Metformin
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.
Drug: Atorvastatin · Drug: Placebo
Participants will receive atorvastatin 20 mg daily.
Participants will receive metformin 1000 mg daily.
Participants will receive placebo 1000 mg daily, mimicking the appearance of metformin without containing active ingredients.
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
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.
Time frame: Baseline, 3rd month, 6th month
Change from Baseline in Fasting insulin Concentration
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: baseline, 6 months
Glycated Albumin (GA)
Time frame: Baseline, 3rd month, 6th month
Not enrolling at this site.
Not enrolling at this site.
Not enrolling at this site.
Not enrolling at this site.
Not enrolling at this site.
Not enrolling at this site.
Plan to share: Yes
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Started Jul 2025 (actual). Primary completion is estimated for Dec 2027, 29 months after the start.
Of 113 phase 3 interventional studies under Schizophrenia, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 46. This study's planned 29 months is close to that.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Metformin