Metformin Treatment on Cognitive Impairment of Schizophrenia (NCT05838573) | Clinical Trial Compass
CompletedPhase 3
Metformin Treatment on Cognitive Impairment of Schizophrenia
China120 participantsStarted 2023-05-08
Plain-language summary
In this study, the investigators will investigate the effect and the underlying mechanism of metformin treatment on cognitive impairment in individuals with schizophrenia. The study will recruit 120 individuals with schizophrenia at 4 sites, who will be randomized to metformin or placebo group for 24-week treatment. Clinical assessments will be done at screen/baseline, 12th week and 24th week. Participants who don't meet any of the diagnostic criteria for metabolic syndrome will only accept baseline evaluations. The specific aims are to compare healthy volunteers versus schizophrenic participants on:1) cognition; 2) MRI features, and to compare metformin group versus placebo group of 24-week treatment cohort on: 1) cognition; 2) clinical core symptoms; 3) MRI features. Biological samples also will be collected and stored to explore related mechanisms.
Who can participate
Age range
18 Years – 50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Male and female aged 18 to 50 years, who meet the Diagnostic and Statistical Manual (DSM-5) diagnostic criteria for schizophrenia.
. Duration of illness less than 15 years with current symptoms in a stable condition.
. 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.
. Have great compliance with medication and follow-up.
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial tested metformin — a diabetes drug — in people with schizophrenia to see if it helps with cognitive problems like memory and thinking; is that something worth discussing for my situation, and how does metformin's known safety profile compare to other options for cognitive symptoms?
2The trial measured cognitive improvement using a specialized battery of tests called the MATICS Consensus Cognitive Battery — how would my doctor actually assess whether my cognition is changing over time if we tried an approach like this?
3The trial also looked at brain blood flow changes using a brain scan technique called arterial spin labeling; do I need that kind of specialized imaging to be monitored, and is that available and practical where I receive care?
4Since this is a completed Phase 3 trial, the results should be available soon or already published — has my doctor seen the findings, and do they suggest metformin meaningfully helped cognition in people with schizophrenia?
5Before considering something like metformin for cognitive symptoms, what standard treatments or approaches should I try first, and how does my doctor weigh the potential benefits against adding another medication to my current regimen?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Changes of the score of the Measurement and Treatment Research to Improve Cognition in Schizophrenia Consensus Cognitive Battery of interventional participants
Timeframe: From baseline to 12th week；From baseline to 24th week；
2
Changes of brain cerebral blood flow by arterial spin labeling of interventional participants
Timeframe: From baseline to 12th week；From baseline to 24th week