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

April 8, 2023 updated by: Renrong Wu, Central South University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Hunan
      • Changsha, Hunan, China, 410011
        • Recruiting
        • The Second Xiangya Hospital of Central South University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Dongyu Kang, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: metformin treatment
Drug: metformin
metformin 1500mg per day
No Intervention: non-metformin treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cognitive improvement will be assessed using the MATRICS Consensus Cognitive Battery (MCCB) composite score
Time Frame: 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.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of clinical symptoms by PANSS
Time Frame: 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.
12 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Depression by CDSS-C
Time Frame: 12 weeks
The investigators will assess depression by Calgary Depression Scale for Schizophrenia （Chinese version, CDSS-C）
12 weeks
Biological markers will be measured by ELISA
Time Frame: 12 weeks
The oxidative stress indexes and inflammatory biomarkers will measured by Enzyme-linked Immuno Sorbent Assay (ELISA).
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central South University

Investigators

  • Principal Investigator: DongYu Kang, M.D., Central South University
  • Principal Investigator: Tiannan Shao, M.D., Ph.D., Central South University
  • Study Chair: Renrong Wu, M.D., Ph.D., Central South University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 28, 2017

Primary Completion (Anticipated)

December 31, 2023

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

August 30, 2017

First Submitted That Met QC Criteria

September 1, 2017

First Posted (Actual)

September 5, 2017

Study Record Updates

Last Update Posted (Actual)

April 11, 2023

Last Update Submitted That Met QC Criteria

April 8, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WU201708MET

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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