Metformin Treatment on Cognitive Impairment of Schizophrenia Co-morbid Metabolic Syndrome

• Status: Recruiting
• Trial end date: 2020-12-01
• Target enrollment: 0
• Participant gender: All

Summary

In this study, the investigators will investigate the impact and the related mechanism of metformin treatment on cognitive impairment of schizophrenia co-morbid metabolic syndrome (Sch-MetS). The study will recruit 40 Sch-MetS patients, 40 patients with schizophrenia only, and 40 patients with schizophrenia and higher risk factors for MetS. Then these patients will be randomized to metformin group or non-metformin control group (20 patients per arm) for 24 weeks clinic trial. Clinical assessment will be done at screen/baseline, 4 week, 12 weeks and 24 week. The specific aims are to compare metformin group versus controls on: 1) clinical core symptoms; 2) cognition. Biological samples also will be collected, and stored to research related mechanisms.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Central South University
• Treatments: Metformin

Criteria

Inclusion Criteria:

1. Meet the Diagnostic and Statistical Manual (DSM-V) diagnostic criteria for schizophrenia;

2. Duration of illness less than 3 years with current symptoms exacerbation;

3. Male and female with aged 18 to 65 years;

4. PANSS total score < 60 and CDSS-C total score < 6;

5. Signed the study consent for participation;

6. Patients confirmed who did not have MetS, or patients with higher risk factors for MetS, or patients with MetS after laboratory examination.

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. The routine blood tests showing abnormal renal, liver function;

6. Pregnant or lactating women.