SchizophreniaPhase 1LPSNCT03271814
Brain Biomarker on Inflammation Response
A Phase 1 study testing LPS in people with Schizophrenia, run by University of Maryland, Baltimore.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia
- What is being tested?
- LPS
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2025to 15 Dec 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 55 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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 -
Who cannot join
- 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
Show all 14Show fewer
- 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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About this study
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).
Read the 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
- Being tested
- LPS, Placebo
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LPSBiological
0.6 by/kg LPS single dose iv
PlaceboOther
Sterile Water
| Study group | Role | What they receive |
|---|---|---|
| LPS-Patient | Experimental | Schizophrenia patients who are randomized to receive LPS injection. Receives: Biological: LPS |
| LPS-Healthy | Active comparator | Healthy controls who are randomized to receive LPS injection. Receives: Biological: LPS |
| Placebo-Patient | Placebo comparator | Schizophrenia patients who are randomized to receive placebo injection. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
IL-6
Cytokine IL-6 at baseline and response to LPS challenge (to be reported in pg/ml or IU/ml)
Measured: Hourly for 6 hours
Secondary outcomes (1)
Brain imaging structure and function via MRI
Brain imaging at baseline and response to LPS challenge (to be reported in institutional units)
Measured: 3 to 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2017
- Study start1 Jan 2025 (estimated)
- Primary completion15 Dec 2025 (estimated)
- Study completion15 Dec 2025 (estimated)
Why it stopped: PI moved to another institution before enrollment could start.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, L. Elliot Hong, University of Maryland, Baltimore
- Investigators
- L E Hong, M.D., Principal investigator, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03271814
- Sponsor's protocol ID
- HP-00076657
- Acronym
- LPS
- Status last verified
- Nov 2023
- First submitted
- 29 Aug 2017
- Last updated
- 5 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Biomarker on Inflammation Response
- ClinicalTrials.gov ID
- NCT03271814
- Acronym / sponsor ID
- LPS / HP-00076657
- Conditions
- Schizophrenia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI moved to another institution before enrollment could start.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 15 Dec 2025 (estimated)
- Study completion
- 15 Dec 2025 (estimated)
- First posted
- 5 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| LPS-Patient | Experimental | Biological: LPSSchizophrenia patients who are randomized to receive LPS injection. |
| LPS-Healthy | Active comparator | Biological: LPSHealthy controls who are randomized to receive LPS injection. |
| Placebo-Patient | Placebo comparator | Other: PlaceboSchizophrenia patients who are randomized to receive placebo injection. |
Who may qualify
- Ages
- 15 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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 -
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LPS0.6 by/kg LPS single dose iv | Biological | LPS-Healthy, LPS-Patient |
| PlaceboSterile Water | Other | Placebo-Patient |
Primary outcome
IL-6
Time frame: Hourly for 6 hours
Cytokine IL-6 at baseline and response to LPS challenge (to be reported in pg/ml or IU/ml)
1 secondary outcome
Brain imaging structure and function via MRI
Time frame: 3 to 6 hours
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
L E Hong, M.D. principal investigator
University of Maryland, Baltimore
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LPS in people with Schizophrenia, run by University of Maryland, Baltimore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 5 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IL-6 (time frame: Hourly for 6 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2023.