Metformin to prevent statin-related blood sugar changes in people with schizophrenia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In this randomized, double-blind Phase 3 trial, about 200 adults with schizophrenia and dyslipidemia will be assigned to receive atorvastatin plus metformin or atorvastatin plus placebo for six months. Participants must be clinically stable on antipsychotic medication and have normal fasting glucose at entry. Primary outcomes include changes in insulin resistance and fasting blood glucose, with secondary outcomes tracking lipid control and safety. The trial is being conducted at multiple hospitals affiliated with Central South University in China.

Why it matters

Who can join: the full rules

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.

Where it's running

• Mental Health Institute of Second Xiangya Hospital, CSU
  Changsha, Hunan, China Recruiting
• Yueyang Rehabilitation Hospital
  Yueyang, Hunan, China Recruiting
• Zhumadian Second People's Hospital
  Zhumadian, Henan, China Active not recruiting
• The Third Hospital of Changsha County
  Changsha, Hunan, China Active not recruiting
• The Second People's Hospital of Xiangyin County
  Yueyang, Hunan, China Active not recruiting
• Junshan District Psychiatric Rehabilitation Hospital
  Yueyang, Hunan, China Active not recruiting

Study contacts

• Study coordinator: Jing Huang
• Email: jinghuangserena@csu.edu.cn
• Phone: +86 15874290980

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.