Metformin Treatment on Cognitive Impairment of Schizophrenia

• Status: Not yet recruiting
• Trial end date: 2025-12-30
• Target enrollment: 0
• Participant gender: All

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. The specific aims are to compare metformin group versus controls on: 1) cognition; 2) clinical core symptoms. Biological samples also will be collected and stored to explore related mechanisms.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Central South University
• Collaborators: NINGBO KANGNING HOSPITAL; NO.2 PEOPLE'S HOSPITAL OF DALI PREFECTURE; Shandong Mental Health Center
• Treatments: Metformin

Criteria

Inclusion Criteria:

1. Male and female with aged 18 to 50 years, who meet the Diagnostic and Statistical Manual (DSM-5) diagnostic criteria for schizophrenia;

2. Duration of illness less than 10 years with current symptoms in a stable condition;

3. The medication regimen should be unchanged at least 3 months; first-generation antipsychotics will be allowed, but only in the context of no concomitant anticholinergic agents and minimal extrapyramidal symptoms; and antipsychotic medication should be no more than 2;

4. The sum score of PANSS Marder negative factor items is at least 20;

5. Have great compliance on medication and follow-up；

6. 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)systolic blood pressure/diastolic blood pressure ≥130/85 mmHg; 4)at fasting state, total cholesterol ≥1.7 mmol/l; 5)at fasting state, HDL-C <1.04 mmol/L. Otherwise, participant who is at high risk of metabolic syndrome will also be recruited.

7. Signed the study consent for participation.

Exclusion Criteria:

1. Having history of substance dependence or abuse or whose symptoms are caused by the other diagnosable mental disorders;

2. Having history of traumatic brain injury, seizures or other known neurological or organic diseases of the central nervous system;

3. Taking antidepressants, stimulants, mood stabilizer or accepts electricity shock treatment;

4. Having current suicidal or homicidal thoughts or any safety concern by research staff that cannot be manage 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.