Metformin's effect on cognitive impairment in schizophrenia
The Effect of Metformin Treatment on Cognitive Impairment in Individuals With Schizophrenia: A 24-week Multicentre Randomised Controlled Trial
This study tests whether metformin can help improve thinking skills in people with schizophrenia compared to a placebo over 24 weeks.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | All |
| Sponsor | Central South University Academic / other |
| Locations | 4 sites (Changsha, Hunan and 3 other locations) |
| Trial ID | NCT05838573 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of metformin treatment on cognitive impairment in individuals diagnosed with schizophrenia. A total of 120 participants will be randomized into either a metformin or placebo group for a 24-week treatment period. Assessments will include clinical evaluations, MRI scans, and cognitive function tests at baseline, 12 weeks, and 24 weeks. The study aims to compare cognitive and clinical outcomes between the two groups and explore underlying mechanisms through biological sample collection.
Who should consider this trial
Good fit: Ideal candidates are males and females aged 18 to 50 with a diagnosis of schizophrenia and evidence of metabolic syndrome.
Not a fit: Patients who do not meet the diagnostic criteria for metabolic syndrome or have a duration of illness exceeding 15 years may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve cognitive function in patients with schizophrenia, enhancing their overall quality of life.
How similar studies have performed: While the use of metformin in schizophrenia is being explored, this specific approach focusing on cognitive impairment is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Male and female aged 18 to 50 years, who meet the Diagnostic and Statistical Manual (DSM-5) diagnostic criteria for schizophrenia. 2. Duration of illness less than 15 years with current symptoms in a stable condition. 3. 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. 4. Have great compliance with medication and follow-up. 5. 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. 6. Signed the study consent for participation. Exclusion Criteria: 1. Having a history of substance dependence or abuse or whose symptoms are caused by other diagnosable mental disorders. 2. Having a history of traumatic brain injury, seizures or other known neurological or organic diseases of the central nervous system. 3. Taking antidepressants, stimulants, mood stabilizers or accepts electricity shock treatment. 4. Having current suicidal or homicidal thoughts or any safety concern by research staff that cannot be managed in an inpatient setting. 5. Taking dementia related drugs, minocycline, and other drugs that could affect cognitive function. 6. The routine blood tests showing significant abnormal renal, liver function or other somatic disease. 7. Pregnant or lactating women. For schizophrenic participants who don't meet any of the diagnostic criteria for metabolic syndrome will only accept baseline evaluations.
Where this trial is running
Changsha, Hunan and 3 other locations
- Mental Health Institute of Second Xiangya Hospital,CSU — Changsha, Hunan, China (Recruiting)
- The Third Peoples's Hospital of Jiangyin — Jiangyin, Jiangsu, China (Recruiting)
- Shandong Mental Health Center — Jinan, Shandong, China (Recruiting)
- The Second People's Hospital of Dali Bai Autonomous Prefecture — Dali, Yunnan, China (Recruiting)
Study contacts
- Study coordinator: Jing Huang, M.D.
- Email: jinghuangserena@csu.edu.cn
- Phone: 15874290980
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.