Metformin Treatment on Cognitive Impairment of Schizophrenia

Launched by CENTRAL SOUTH UNIVERSITY · Apr 28, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at how metformin, a medication often used for diabetes, may help improve thinking and memory problems in people with schizophrenia. The study will include 120 participants who will be assigned to either receive metformin or a placebo (a dummy treatment) for 24 weeks. Throughout the trial, researchers will evaluate participants' cognitive abilities, mental health symptoms, and brain images at the beginning, halfway through, and at the end of the study.

To be eligible, participants must be between 18 and 50 years old, diagnosed with schizophrenia, and currently stable on their medications. They should also meet certain health criteria related to metabolic syndrome, which includes factors like obesity and blood sugar levels. Participants will be closely monitored and will need to commit to regular check-ups. This study is important because it may help us understand how metformin works in people with schizophrenia and could lead to better treatments for cognitive issues in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Male and female with aged 18 to 50 years, who meet the Diagnostic and Statistical Manual (DSM-5) diagnostic criteria for schizophrenia;
• • 2. Duration of illness less than 15 years with current symptoms in a stable condition;
• • 3. Participants must be receiving stable treatment with standard-of-care medications, with a maximum allowance of two antipsychotic medications. If additional anticholinergic agents are required for the management of extrapyramidal symptoms, they should be prescribed at low dosages;
• • 4. Have great compliance on medication and follow-up；
• • 5. Meet one of the diagnostic criteria for metabolic syndrome: 1)abdominal obesity (i.e. central obesity): waist circumference for male≥90 cm, for female ≥85 cm; 2)fasting blood glucose ≥110 mg/dl (6.1 mmol/l) and/or plasma glucose ≥140 mg/dl (7.8 mmol/l) after glucose load; 3)at fasting state, triglyceride ≥1.7 mmol/l; 4)at fasting state, HDL-C \<1.04 mmol/L.
• • 6. Signed the study consent for participation.
• Exclusion Criteria:
• • 1. Having history of substance dependence or abuse or whose symptoms are caused by the other diagnosable mental disorders;
• • 2. Having history of traumatic brain injury, seizures or other known neurological or organic diseases of the central nervous system;
• • 3. Taking antidepressants, stimulants, mood stabilizer or accepts electricity shock treatment;
• • 4. Having current suicidal or homicidal thoughts or any safety concern by research staff that cannot be manage in an inpatient setting;
• • 5. Taking dementia related drugs, minocycline, and other drugs that could affect cognitive function.
• • 6. The routine blood tests showing significant abnormal renal, liver function or other somatic disease.
• • 7. Pregnant or lactating women.
• • For schizophrenic participants who don't meet any of the diagnostic criteria for metabolic syndrome will only accept baseline evaluations.