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

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ClinicalTrials.gov Identifier: NCT03271866
Recruitment Status : Unknown
Verified June 2020 by Renrong Wu, Central South University.
Recruitment status was:  Recruiting
First Posted : September 5, 2017
Last Update Posted : June 30, 2020
Sponsor:
Information provided by (Responsible Party):
Renrong Wu, Central South University

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: metformin Not Applicable

Detailed Description:

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 but without MetS, 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 12 weeks clinic trial. Clinical assessment will be done at screen/baseline, 4 week, 12 week 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. 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 cognitive impairment of patients with Sch-MetS; 2) metformin could prevent cognitive decline of patients with schizophrenia only and patients with schizophrenia and higher risk factors for MetS; 3) metformin may alter oxidative stress indexes or inflammatory biomarkers thus influence the oxidative and inflammatory mechanism, and the structure and function of hippocampus that may be significantly associated with cognitive function.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Metformin Treatment on Cognitive Impairment in Patients With Schizophrenia Co-morbid Metabolic Syndrome: a Prospective Cohort Study
Actual Study Start Date : August 28, 2017
Estimated Primary Completion Date : November 1, 2020
Estimated Study Completion Date : December 1, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
metformin treatment Drug: metformin
metformin 1500mg per day
No Intervention: non-metformin treatment


Outcome Measures
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Primary Outcome Measures :
  1. Cognitive improvement will be assessed using the MATRICS Consensus Cognitive Battery (MCCB) composite score [ Time Frame: 24 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 Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. Depression by CDSS-C [ Time Frame: 12 weeks ]
    The investigators will assess depression by Calgary Depression Scale for Schizophrenia （Chinese version, CDSS-C）

  2. 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).


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03271866


Contacts
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Contact: Tiannan Shao, M.D., Ph.D. +86 13341318057 shaostndoc@163.com

Locations
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China, Hunan
The Second Xiangya Hospital of Central South University Recruiting
Changsha, Hunan, China, 410011
Contact: Tiannan Shao, M.D., Ph.D.    +86 13341318057    shaostndoc@163.com   
Contact: Renrong Wu, M.D., Ph.D.       wurenrong2013@163.com   
Principal Investigator: Dongyu Kang, M.D.         
Sponsors and Collaborators
Central South University
Investigators
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Principal Investigator: Tiannan Shao, M.D., Ph.D. Central South University
Principal Investigator: Dongyu Kang, M.D. Central South University
Study Chair: Renrong Wu, M.D., Ph.D. Central South University
More Information
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Publications:

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Responsible Party: Renrong Wu, Professor, Central South University
ClinicalTrials.gov Identifier: NCT03271866    
Other Study ID Numbers: WU201708MET
First Posted: September 5, 2017    Key Record Dates
Last Update Posted: June 30, 2020
Last Verified: June 2020

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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
Keywords provided by Renrong Wu, Central South University:
Schizophrenia
Metabolic syndrome
Metformin
Cognitive impairment
Clinical trial
Additional relevant MeSH terms:
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Metabolic Syndrome
Schizophrenia
Cognitive Dysfunction
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Cognition Disorders
Neurocognitive Disorders
 Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs