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

Schizophrenia Clinical Trial

Official title:

The Effect of Metformin Treatment on Cognitive Impairment in Patients With Schizophrenia Co-morbid Metabolic Syndrome: a Prospective Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03271866
• Other study ID #: WU201708MET
• Status: Recruiting
• Phase: N/A
• Start date: August 28, 2017
• Est. completion date: December 31, 2023

Study information

• Verified date: April 2023
• Source: Central South University
• Contact: Tiannan Shao, M.D., Ph.D.
• Phone: +86 13341318057
• Email: shaostndoc[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Metabolic Syndrome
• Schizophrenia

Intervention

Drug:
• metformin
metformin 1500mg per day

Locations

Country	Name	City	State
China	The Second Xiangya Hospital of Central South University	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Central South University

Country where clinical trial is conducted

China, 

References & Publications (3)

Bora E, Akdede BB, Alptekin K. The relationship between cognitive impairment in schizophrenia and metabolic syndrome: a systematic review and meta-analysis. Psychol Med. 2017 Apr;47(6):1030-1040. doi: 10.1017/S0033291716003366. Epub 2016 Dec 29. Erratum In: Psychol Med. 2018 May;48(7):1224. — View Citation

Lindenmayer JP, Khan A, Kaushik S, Thanju A, Praveen R, Hoffman L, Cherath L, Valdez G, Wance D. Relationship between metabolic syndrome and cognition in patients with schizophrenia. Schizophr Res. 2012 Dec;142(1-3):171-6. doi: 10.1016/j.schres.2012.09.019. Epub 2012 Oct 26. — View Citation

Ying MA, Maruschak N, Mansur R, Carvalho AF, Cha DS, McIntyre RS. Metformin: repurposing opportunities for cognitive and mood dysfunction. CNS Neurol Disord Drug Targets. 2014;13(10):1836-45. doi: 10.2174/1871527313666141130205514. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Depression by CDSS-C	The investigators will assess depression by Calgary Depression Scale for Schizophrenia (Chinese version, CDSS-C)	12 weeks
Other	Biological markers will be measured by ELISA	The oxidative stress indexes and inflammatory biomarkers will measured by Enzyme-linked Immuno Sorbent Assay (ELISA).	12 weeks
Primary	Cognitive improvement will be assessed using the MATRICS Consensus Cognitive Battery (MCCB) composite score	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.	12 weeks
Secondary	Change of clinical symptoms by PANSS	The change of Positive And Negative Syndrome Scale (PANSS) total, positive and negative symptoms before and after treatment at different follow up point.	12 weeks