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New treatment option for Schizophrenia
Official title Metformin Alleviates Abnormal Glucose Metabolism Induced by Statins in Schizophrenia Patients
ClinicalTrials.gov ID: NCT07045142
What this study is testing
What is Atorvastatin?
Atorvastatin is an investigational medicine, given as an once-daily, being studied as a potential treatment for schizophrenia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- Aged between 18 and 65 years, regardless of gender, and meets the diagnostic criteria for schizophrenia according to the Diagnostic and Statistical...
- Symptoms and medication regimen stable for more than 3 months, with the allowance of up to two antipsychotic medications in combination (concurrent...
- 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...
- Two fasting blood glucose (FPG) tests must be \< 6.1 mmol/L (with an interval of 1-4 weeks);
You likely can't join if
- 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...
- Patients with severe gastrointestinal, respiratory, endocrine, hematologic diseases, or metabolic absorption disorders: including but not limited to...
- Clinically significant abnormal ECG findings at screening that the investigator deems unsuitable for inclusion, such as male QTc interval \> 470 ms...
- Pregnant or nursing women.
See the full eligibility criteria
- 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.
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Zhumadian, Henan, China
- Changsha, Hunan, China
- Yueyang, Hunan, China
- Dali, Yunnan, China
- Xiangshan, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Zhumadian, Henan, China; Changsha, Hunan, China; Yueyang, Hunan, China; Dali, Yunnan, China; Xiangshan, Zhejiang, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.