Schizophrenia
Conditions
Keywords
Schizophrenia, Metabolic syndrome, Metformin, Cognitive impairment, Clinical trial
Brief summary
In this study, the investigators will investigate the impact and the related mechanism of metformin treatment on cognitive impairment of schizophrenia with a high risk of metabolic syndrome. Patients will be randomized to the metformin group or non-metformin control group (40 patients per arm) for 24 weeks. Clinical assessment will be done at screen/baseline, 4 weeks, 12 weeks, and 24 weeks. The specific aims are to compare the metformin group versus controls on 1) clinical core symptoms; 2) cognition. Biological samples also will be collected, and stored to research related mechanisms.
Detailed description
In this study, the investigators will investigate the impact and the related mechanism of metformin treatment on cognitive impairment of schizophrenia with a high risk of metabolic syndrome. Patients will be randomized to the metformin group or non-metformin control group (40 patients per arm) . Clinical assessment will be done at screen/baseline, 4 week, 12 week and 24 week. The specific aims are to compare the metformin group versus controls on: 1) clinical core symptoms; 2) cognition. Biological samples also will be collected, and stored to research related mechanisms. Clinical symptoms will be measured by the Positive and Negative Syndrome Scale and Calgary Depression Scale for Schizophrenia (Chinese version). Cognitive function will be assessed by the MATRICS Consensus Cognitive Battery. The investigators hypothesize that 1) metformin may improve the cognitive impairment of schizophrenia patients; 2) metformin may alter oxidative stress indexes or inflammatory biomarkers thus influencing the oxidative and inflammatory mechanism, and the structure and function of the hippocampus that may be significantly associated with cognitive function.
Interventions
DRUGmetformin
metformin 1500mg per day
Sponsors
Central South University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Two groups were observed longitudinally for 24 weeks.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Meet the Diagnostic and Statistical Manual (DSM-5) diagnostic criteria for schizophrenia; 2. Duration of illness less than 5 years with current symptoms exacerbation; 3. Male and female 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 with higher risk factors for MetS, or patients who gained weight \> 10% of their pre-drug weight within the first year after antipsychotic medication.
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 accepting 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. The routine blood tests showing abnormal renal, and liver function; 6. Pregnant or lactating women.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cognitive improvement will be assessed using the MATRICS Consensus Cognitive Battery (MCCB) composite score | 12 weeks | The investigators will use the MATRICS Consensus Cognitive Battery (MCCB) Composite score as primary cognitive outcome measure before and after treatment at different follow up point. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change of clinical symptoms by PANSS | 12 weeks | The change of Positive And Negative Syndrome Scale (PANSS) total, positive and negative symptoms before and after treatment at different follow up point. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Depression by CDSS-C | 12 weeks | The investigators will assess depression by Calgary Depression Scale for Schizophrenia （Chinese version, CDSS-C） |
| Biological markers will be measured by ELISA | 12 weeks | The oxidative stress indexes and inflammatory biomarkers will measured by Enzyme-linked Immuno Sorbent Assay (ELISA). |
Countries
China
Contacts
Primary ContactTiannan Shao, M.D., Ph.D.
Outcome results
None listed