Ignite Creation Date:
2024-05-06 @ 10:31 AM
Last Modification Date:
2024-10-26 @ 12:31 PM
Study NCT ID:
NCT03271814
Status:
WITHDRAWN
Last Update Posted:
2023-12-05
First Post:
2017-08-29
Brief Title:
Brain Biomarker on Inflammation Response
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Brain Biomarker on Inflammation Response
Status:
WITHDRAWN
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
PI moved to another institution before enrollment could start
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LPS
Brief Summary:
In a double-blinded randomized parallel controlled design patients with schizophrenia spectrum disorder will be exposed to a single dose of lipopolysaccharide LPS LPS-patient Clinical symptoms blood samples and brain imaging will be assessed at baseline and after LPS There will be two comparison groups Comparison groups include an age- and sex-matched healthy control group also exposed to the same LPS LPS-control and an age- and sex-matched sample of patients with schizophrenia on placebo Placebo-patient As in Phase I studies multiple interim analyses are expected so the current design may be modified which will be communicated during annual reports 21CFR31230
Detailed Description:
Schizophrenia spectrum disorders are a major public health burden due to functional and cognitive impairment psychosis and other symptoms and high comorbidity Unfortunately current therapies have limited effectiveness in treating some of the symptoms and most of the cognitive deficits Alternative biological models of the disease are needed for developing new and more effective treatment Neuroinflammation has increasingly been implicated in the pathophysiology of schizophrenia Patients with schizophrenia have signs of low-grade chronic inflammation including elevated blood levels of pro-inflammatory cytokines and other immune markers Administration of LPS is the standard immune challenge to investigate the bodys immune response in a wide range of disorders Our goal is to use LPS to investigate whether schizophrenia patients have abnormal immune response to LPS and whether the abnormality is associated with specific brain imaging biomarkers
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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