Status:
WITHDRAWN
Brain Biomarker on Inflammation Response
Lead Sponsor:
University of Maryland, Baltimore
Conditions:
Schizophrenia
Eligibility:
All Genders
15-55 years
Phase:
PHASE1
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...
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 ...
Eligibility Criteria
Inclusion
- 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 -
Exclusion
- 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
- 12-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
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Key Trial Info
Start Date :
January 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 15 2025
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03271814
Start Date
January 1 2025
End Date
December 15 2025
Last Update
December 5 2023
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