Brain Biomarker on Inflammation Response

NCT03271814 | Withdrawn Phase 1 DMC FDA Drug

• 1 other identifier: HP-00076657
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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 (21CFR312.30).

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (1)

• IL-6

  Cytokine IL-6 at baseline and response to LPS challenge (to be reported in pg/ml or IU/ml)

  Hourly for 6 hours

Secondary Outcomes (1)

• Brain imaging structure and function via MRI

  3 to 6 hours

Study Arms (3)

LPS-Patient

EXPERIMENTAL

Schizophrenia patients who are randomized to receive LPS injection.

Biological: LPS

LPS-Healthy

ACTIVE COMPARATOR

Healthy controls who are randomized to receive LPS injection.

Biological: LPS

Placebo-Patient

PLACEBO COMPARATOR

Schizophrenia patients who are randomized to receive placebo injection.

Other: Placebo

Interventions

LPS BIOLOGICAL

0.6 by/kg LPS single dose iv

LPS-Healthy; LPS-Patient

Placebo OTHER

Sterile Water

Placebo-Patient

Eligibility Criteria

• Age: 15 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age 18-55
• Patients must be on antipsychotic medication and clinically stable, defined as no hospitalization or major change in antipsychotic medication in the past 4 weeks
• Patients must pass the ESC with score 10 or above
• BMI 35 or less -

You may not qualify if:

• History of major medical illness including, but not limited to, history of heart attack, stroke, TIA (transient ischemic attack)
• History of organic brain disorders that may affect neurophysiological measurements, including seizure disorder, brain tumor, head injury with evidence of significant cognitive deterioration
• DSM diagnosis of substance use disorder within 6 months except nicotine and marijuana
• Prior suicide attempt or frequent suicidal ideations, or current suicidal ideation assessed by the Columbia Suicide Severity Rating Scale (C-SSRS)
• Women who have positive urine pregnancy tests; Women who plan to become pregnant, or are breastfeeding
• Frequent (more than once) history of syncope (fainting) of unknown reason
• Unable to undergo MRI scanning due to metallic devices or objects or claustrophobia
• Presence of co-morbid inflammatory disorders such as rheumatoid arthritis
• Presence of acute or chronic infection; have received flu or similar vaccine in the past 4 weeks
• Current regular use of non-steroidal anti-inflammatory drugs or immune modifying drugs
• Clinically significant abnormalities on screening laboratory tests
• Blood pressure \<90/60 or \> 150/100, or pulse \<55 or \> 100 beats/minute, or temperature \> 99.5°F
• Lead ECG demonstrating QTcF \>450 msec or a QRS interval \>120 msec. If QTcF exceeds 450 msec, or QRS exceeds 120 msec, the ECG should be repeated two more times and the average of the three QTcF values should be used to determine the subject's eligibility

Sponsors & Collaborators

• University of Maryland, Baltimore: lead

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• L E Hong, M.D.

  University of Maryland, Baltimore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 29, 2017
• First Posted: September 5, 2017
• Study Start: January 1, 2025
• Primary Completion: December 15, 2025
• Study Completion: December 15, 2025
• Last Updated: December 5, 2023

Record last verified: 2023-11