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Metformin Treatment on Cognitive Impairment of Schizophrenia
Sponsor: Central South University
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.
Official title: The Effect of Metformin Treatment on Cognitive Impairment in Individuals With Schizophrenia: A 24-week Multicentre Randomised Controlled Trial
Key Details
Gender
All
Age Range
18 Years - 50 Years
Study Type
INTERVENTIONAL
Enrollment
120
Start Date
2023-05-08
Completion Date
2027-06-30
Last Updated
2025-12-19
Healthy Volunteers
Yes
Conditions
Interventions
Metformin 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.
Placebo treatment
Parallel-dose adjustments will be made for the placebo group to maintain consistency in dosing between the two groups.
Baseline assessments
Schizophrenic participants who don't meet any of the diagnostic criteria for metabolic syndrome will only accept baseline evaluations.
Volunteer 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.
Locations (4)
Mental Health Institute of Second Xiangya Hospital,CSU
Changsha, Hunan, China
The Third Peoples's Hospital of Jiangyin
Jiangyin, Jiangsu, China
Shandong Mental Health Center
Jinan, Shandong, China
The Second People's Hospital of Dali Bai Autonomous Prefecture
Dali, Yunnan, China