NCT03271814

Brain Biomarker on Inflammation Response

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Maryland, Baltimore · Academic / Other
• Sex: All
• Age: 15 Years – 55 Years
• Healthy volunteers: Accepted

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 (21CFR312.30).

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 body's 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.

Conditions

• Schizophrenia

Interventions

Type	Name	Description
BIOLOGICAL	LPS	0.6 by/kg LPS single dose iv
OTHER	Placebo	Sterile Water

Timeline

• Start date: 2025-01-01
• Primary completion: 2025-12-15
• Completion: 2025-12-15
• First posted: 2017-09-05
• Last updated: 2023-12-05

Regulatory

• FDA-regulated drug study