NCT07045142 Metformin Alleviates Abnormal Glucose Metabolism Induced by Statins in Schizophrenia Patients
| NCT ID | NCT07045142 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Central South University |
| Condition | Schizophrenia |
| Study Type | INTERVENTIONAL |
| Enrollment | 400 participants |
| Start Date | 2025-07-01 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 400 participants in total. It began in 2025-07-01 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility Criteria
Inclusion criteria: 1. 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); 2. 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); 3. Temporary use of benzodiazepines is allowed; 4. 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; 5. Two fasting blood glucose (FPG) tests must be \< 6.1 mmol/L (with an interval of 1-4 weeks); 6. It is anticipated that there will be no issues related to relocation, transportation difficulties, or access to medical care throughout the study; 7. Informed consent must be obtained from the patient and their guardian, and a consent form must be signed. Exclusion criteria: 1. Patients with a prior diagnosis of diabetes or complications such as diabetic ketoacidosis; 2. 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; 3. 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; 4. 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; 5. Pregnant or nursing women.
Contact & Investigator
Renrong Wu
STUDY CHAIR
Mental Health Institute of Second Xiangya Hospital,CSU
Frequently Asked Questions
Who can join the NCT07045142 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Schizophrenia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07045142 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 400 participants.
Is NCT07045142 currently recruiting?
Yes, NCT07045142 is actively recruiting participants. Contact the research team at jinghuangserena@csu.edu.cn for enrollment information.
Where is the NCT07045142 trial being conducted?
This trial is being conducted at Zhumadian, China, Changsha, China, Changsha, China, Yueyang, China and 4 additional locations.
Who is sponsoring the NCT07045142 clinical trial?
NCT07045142 is sponsored by Central South University. The principal investigator is Renrong Wu at Mental Health Institute of Second Xiangya Hospital,CSU. The trial plans to enroll 400 participants.
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