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

Primary Purpose

Schizophrenia

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
metformin
Sponsored by
Central South University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia, Metabolic syndrome, Metformin, Cognitive impairment, Clinical trial

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The Second Xiangya Hospital of Central South UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

No Intervention

Arm Label

metformin treatment

non-metformin treatment

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
August 30, 2017
Last Updated
April 8, 2023
Sponsor
Central South University
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1. Study Identification

Unique Protocol Identification Number
NCT03271866
Brief Title
Metformin Treatment on Cognitive Impairment of Schizophrenia Co-morbid Metabolic Syndrome
Official Title
The Effect of Metformin Treatment on Cognitive Impairment in Patients With Schizophrenia Co-morbid Metabolic Syndrome: a Prospective Cohort Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 28, 2017 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Central South University

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Schizophrenia, Metabolic syndrome, Metformin, Cognitive impairment, Clinical trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two groups were observed longitudinally for 24 weeks.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
metformin treatment
Arm Type
Other
Arm Title
non-metformin treatment
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
metformin
Intervention Description
metformin 1500mg per day
Primary Outcome Measure Information:
Title
Cognitive improvement will be assessed using the MATRICS Consensus Cognitive Battery (MCCB) composite score
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Change of clinical symptoms by PANSS
Description
The change of Positive And Negative Syndrome Scale (PANSS) total, positive and negative symptoms before and after treatment at different follow up point.
Time Frame
12 weeks
Other Pre-specified Outcome Measures:
Title
Depression by CDSS-C
Description
The investigators will assess depression by Calgary Depression Scale for Schizophrenia （Chinese version, CDSS-C）
Time Frame
12 weeks
Title
Biological markers will be measured by ELISA
Description
The oxidative stress indexes and inflammatory biomarkers will measured by Enzyme-linked Immuno Sorbent Assay (ELISA).
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Meet the Diagnostic and Statistical Manual (DSM-5) diagnostic criteria for schizophrenia; Duration of illness less than 5 years with current symptoms exacerbation; Male and female aged 18 to 65 years; PANSS total score < 60 and CDSS-C total score < 6; Signed the study consent for participation; 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: Having a history of substance dependence or abuse or whose symptoms are caused by other diagnosable mental disorders; Having a history of traumatic brain injury, seizures, or other known neurological or organic diseases of the central nervous system; Taking antidepressants, stimulants, mood stabilizers or accepting electricity shock treatment; Having current suicidal or homicidal thoughts or any safety concern by research staff that cannot be managed in an inpatient setting; The routine blood tests showing abnormal renal, and liver function; Pregnant or lactating women.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tiannan Shao, M.D., Ph.D.
Phone
+86 13341318057
Email
shaostndoc@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tiannan Shao, M.D., Ph.D.
Organizational Affiliation
Central South University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dongyu Kang, M.D.
Organizational Affiliation
Central South University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Renrong Wu, M.D., Ph.D.
Organizational Affiliation
Central South University
Official's Role
Study Chair
Facility Information:
Facility Name
The Second Xiangya Hospital of Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410011
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tiannan Shao, M.D., Ph.D.
Phone
+86 13341318057
Email
shaostndoc@163.com
First Name & Middle Initial & Last Name & Degree
Renrong Wu, M.D., Ph.D.
Email
wurenrong2013@163.com
First Name & Middle Initial & Last Name & Degree
Dongyu Kang, M.D.

12. IPD Sharing Statement

Citations:
PubMed Identifier
23106932
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.
Results Reference
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PubMed Identifier
28032535
Citation
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.
Results Reference
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PubMed Identifier
25470390
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.
Results Reference
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Metformin Treatment on Cognitive Impairment of Schizophrenia Co-morbid Metabolic Syndrome

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