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
Central South University
120 participants
May 8, 2023
INTERVENTIONAL
Conditions
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
Inclusion Criteria6
- 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.
- Signed the study consent for participation.
Exclusion Criteria8
- Having a history of substance dependence or abuse or whose symptoms are caused by other diagnosable mental disorders.
- Having a history of traumatic brain injury, seizures or other known neurological or organic diseases of the central nervous system.
- Taking antidepressants, stimulants, mood stabilizers or accepts electricity shock treatment.
- Having current suicidal or homicidal thoughts or any safety concern by research staff that cannot be managed in an inpatient setting.
- Taking dementia related drugs, minocycline, and other drugs that could affect cognitive function.
- The routine blood tests showing significant abnormal renal, liver function or other somatic disease.
- Pregnant or lactating women.
- For schizophrenic participants who don't meet any of the diagnostic criteria for metabolic syndrome will only accept baseline evaluations.
Interventions
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.
Parallel-dose adjustments will be made for the placebo group to maintain consistency in dosing between the two groups.
Schizophrenic participants who don't meet any of the diagnostic criteria for metabolic syndrome will only accept baseline evaluations.
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.
Locations(4)
View Full Details on ClinicalTrials.gov
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NCT05838573