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Brain Biomarker on Inflammation Response

NCT03271814 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2023-12-05

No results posted yet for this study

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).

Conditions

Interventions

BIOLOGICAL

LPS

0.6 by/kg LPS single dose iv

OTHER

Placebo

Sterile Water

Sponsors & Collaborators

  • University of Maryland, Baltimore

    lead OTHER

Principal Investigators

  • L E Hong, M.D. · University of Maryland, Baltimore

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
15 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-01-01
Primary Completion
2025-12-15
Completion
2025-12-15
FDA Drug
Yes

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03271814 on ClinicalTrials.gov