RecruitingPhase 3NCT05838573

Metformin Treatment on Cognitive Impairment of Schizophrenia

The Effect of Metformin Treatment on Cognitive Impairment in Individuals With Schizophrenia: A 24-week Multicentre Randomised Controlled Trial

Sponsor

Central South University

Enrollment

120 participants

Start Date

May 8, 2023

Study Type

INTERVENTIONAL

Conditions

Schizophrenia

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.

Eligibility

Min Age: 18 YearsMax Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This study is exploring whether metformin — a common diabetes medication — can improve memory, attention, and thinking problems in people with schizophrenia. Cognitive impairment is a common and difficult-to-treat symptom of schizophrenia, and researchers believe metformin may help through its effects on brain metabolism. **You may be eligible if...** - You are 18 to 50 years old and have been diagnosed with schizophrenia - Your illness duration is less than 15 years and your symptoms are currently stable - You are on stable antipsychotic medication (up to two medications allowed) - You do not have diabetes **You may NOT be eligible if...** - You have diabetes or are already taking metformin - Your schizophrenia symptoms are currently unstable or acute - You have significant kidney or liver problems - You are pregnant or planning to become pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGMetformin treatment

Participants assigned to the metformin group will receive 500mg metformin three times daily (tid) for 24 weeks. The initial dose will be 500 mg orally in the evening for the first two days, followed by an increase to 500mg twice a day for the subsequent two days. By day 5, the dosage will be further increased to 500mg tid. The highest tolerated dosage will be maintained for participants who could not tolerate the maximum dosage.

DRUGPlacebo treatment

Parallel-dose adjustments will be made for the placebo group to maintain consistency in dosing between the two groups.

OTHERBaseline assessments

Schizophrenic participants who don't meet any of the diagnostic criteria for metabolic syndrome will only accept baseline evaluations.

OTHERVolunteer assessments

Apart from psychiatry scales(Hamilton Depression Scale, Young Mania Rating Scale and Self-reporting Inventory-90), other assessments for the healthy subjects are the same as the baseline for sczhiophrenic participants.