Actively Recruiting
Metformin Treatment on Cognitive Impairment of Schizophrenia
Led by Central South University · Updated on 2025-12-19
120
Participants Needed
4
Research Sites
216 weeks
Total Duration
On this page
Sponsors
C
Central South University
Lead Sponsor
S
Shandong Mental Health Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Metformin Treatment on Cognitive Impairment of Schizophrenia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female aged 18 to 50 years who meet DSM-5 criteria for schizophrenia
- Illness duration less than 15 years with stable current symptoms
- Receiving stable treatment with standard-of-care medications, allowing up to two antipsychotic drugs
- If needed, low-dose anticholinergic agents for extrapyramidal symptoms
- Good compliance with medication and follow-up
- Meet at least one metabolic syndrome diagnostic criterion: abdominal obesity (waist circumference 60 cm male, 65 cm female), fasting blood glucose 6110 mg/dl, plasma glucose 6140 mg/dl after glucose load, fasting triglycerides 61.7 mmol/l, or fasting HDL-C <1.04 mmol/L
- Signed informed consent for participation
You will not qualify if you...
- History of substance dependence, abuse, or mental disorders other than schizophrenia
- History of traumatic brain injury, seizures, or known neurological/organic central nervous system diseases
- Currently taking antidepressants, stimulants, mood stabilizers, or receiving electroconvulsive therapy
- Present suicidal or homicidal thoughts, or safety concerns needing inpatient management
- Taking dementia-related drugs, minocycline, or other drugs affecting cognitive function
- Significant abnormal renal or liver function or other serious somatic diseases on routine blood tests
- Pregnant or lactating women
- Participants without metabolic syndrome diagnostic criteria only undergo baseline evaluations
AI-Screening
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Trial Site Locations
Total: 4 locations
1
Mental Health Institute of Second Xiangya Hospital,CSU
Changsha, Hunan, China, 410011
Actively Recruiting
2
The Third Peoples's Hospital of Jiangyin
Jiangyin, Jiangsu, China, 214400
Actively Recruiting
3
Shandong Mental Health Center
Jinan, Shandong, China, 250014
Actively Recruiting
4
The Second People's Hospital of Dali Bai Autonomous Prefecture
Dali, Yunnan, China, 671014
Actively Recruiting
Research Team
J
Jing Huang, M.D.
CONTACT
J
Jingmei Xiao, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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