Ignite Creation Date:
2024-05-06 @ 6:55 PM
Last Modification Date:
2024-10-26 @ 2:57 PM
Study NCT ID:
NCT05838573
Status:
RECRUITING
Last Update Posted:
2024-04-26
First Post:
2023-03-22
Brief Title:
Metformin Treatment on Cognitive Impairment of Schizophrenia
Sponsor:
Central South University
Organization:
Central South University
Study Overview
Official Title:
The Effect of Metformin Treatment on Cognitive Impairment in Individuals with Schizophrenia a 24-week Multicentre Randomised Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In this study the investigators will investigate the effect and the underlying mechanism of metformin treatment on cognitive impairment in individuals with schizophrenia The study will recruit 120 individuals with schizophrenia at 4 sites who will be randomized to metformin or placebo group for 24-week treatment Clinical assessments will be done at screenbaseline 12th week and 24th week Participants who dont meet any of the diagnostic criteria for metabolic syndrome will only accept baseline evaluations The specific aims are to compare healthy volunteers versus schizophrenic participants on1 cognition 2 MRI features and to compare metformin group versus placebo group of 24-week treatment cohort on 1 cognition 2 clinical core symptoms 3 MRI features Biological samples also will be collected and stored to explore related mechanisms
Detailed Description:
Participants screened through inclusion and exclusion criteria will be randomized to metformin or placebo group 21 The information of demographic data medical history previous and current medication regimen and family history regarding psychotic and metabolic diseases will be collected at baseline The assessments will be carried out at baseline 12th week and 24th week including physical examination anthropometry blood testblood routine liver function renal function blood lipids fasting blood glucose serum insulin and thyroid function electrocardiogram MRI scan High-resolution T1-weighted Anatomical Images Diffusion Tensor Imaging Resting-state functional MRI and Arterial Spin Labeling and psychiatry scalesPositive And Negative Syndrome Scale Scale for Assessment of Negative Symptoms Calgary Depressing Scale for Schizophrenia Personal and Social Performance Scale The Systematic Assessment for Treatment Emergent Events the Simpson-Angus Extrapyramidal Side Effects Scale and the Barnes Akathisia Rating Scale cognitive function will be assessed by the Measurement and Treatment Research to Improve Cognition in SchizophreniaMATRICS Consensus Cognitive Battery biological samples also will be collected and stored to explore related mechanisms Participants who dont meet any of the diagnostic criteria for metabolic syndrome will only accept baseline evaluations In addition we will recruit healthy volunteers and collect their demographic data and family history regarding psychotic and metabolic diseases Apart from psychiatry scalesHamilton Depression Scale Young Mania Rating Scale and Self-reporting Inventory-90 other assessments for the healthy subjects are the same as the baseline for sczhiophrenic participants
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None