Metformin Treatment on Cognitive Impairment of Schizophrenia Co-morbid Metabolic Syndrome
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|ClinicalTrials.gov Identifier: NCT03271866|
Recruitment Status : Recruiting
First Posted : September 5, 2017
Last Update Posted : September 5, 2017
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia||Drug: metformin||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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 :||September 1, 2018|
|Estimated Study Completion Date :||March 1, 2019|
metformin 1500mg per day
|No Intervention: non-metformin treatment|
- 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.
- 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.
- Depression by CDSS-C [ Time Frame: 12 weeks ]The investigators will assess depression by Calgary Depression Scale for Schizophrenia （Chinese version, CDSS-C）
- 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).
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
|Contact: Tiannan Shao, M.D., Ph.D.||+86 firstname.lastname@example.org|
|The Second Xiangya Hospital of Central South University||Recruiting|
|Changsha, Hunan, China, 410011|
|Contact: Tiannan Shao, M.D., Ph.D. +86 13341318057 email@example.com|
|Contact: Renrong Wu, M.D., Ph.D. firstname.lastname@example.org|
|Principal Investigator: Dongyu Kang, M.D.|
|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|