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Diabetes risk from statins in schizophrenia: could metformin be the answer?

NCT ID NCT07045142

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Aug 04, 2026 · Updated 5 times

Summary

This study tests whether the diabetes drug metformin can prevent blood sugar increases caused by statins in people with schizophrenia. Researchers will give 400 patients either metformin or a placebo alongside atorvastatin for six months. The goal is to see if metformin helps keep glucose levels stable, reducing the risk of diabetes and heart disease.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Metformin
What this could lead to
If it works, this could offer a way to prevent diabetes in schizophrenia patients who need statins for heart health, improving their overall care.
What could go wrong
This is a phase 3 trial, but it's still early to know if metformin will work for this specific use. The study focuses on blood sugar markers, not long-term health outcomes, and metformin may cause digestive side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 400 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2025

Expected to finish

Jun 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Junshan District Psychiatric Rehabilitation Hospital

    ACTIVE_NOT_RECRUITING

    Yueyang, Hunan, 414000, China

  • Mental Health Institute of Second Xiangya Hospital, CSU

    RECRUITING

    Changsha, Hunan, China

  • The Second People's Hospital of Dali Bai Autonomous Prefecture

    COMPLETED

    Dali, Yunnan, China

  • The Second People's Hospital of Xiangyin County

    ACTIVE_NOT_RECRUITING

    Yueyang, Hunan, 410500, China

  • The Third Hospital of Changsha County

    ACTIVE_NOT_RECRUITING

    Changsha, Hunan, China

  • Xiangshan County Traditional Chinese Medicine Hospital Medical and Health Group Three Hospitals District

    ACTIVE_NOT_RECRUITING

    Xiangshan, Zhejiang, 315799, China

  • Yueyang Rehabilitation Hospital

    RECRUITING

    Yueyang, Hunan, 414022, China

  • Zhumadian Second People's Hospital

    ACTIVE_NOT_RECRUITING

    Zhumadian, Henan, China

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