Anti-Inflammatory Challenge in Schizophrenia

This study is looking at whether reducing inflammation can help improve motivation in people with schizophrenia or schizoaffective disorder. Researchers believe that inflammation might affect brain areas linked to motivation and reward. You might be eligible if you are 18-55 years old, have schizophrenia or schizoaffective disorder, and show signs of both inflammation (measured by a blood test called C-reactive protein, or CRP) and motivational difficulties. Participants will receive either infliximab, a drug that targets inflammation, or a placebo (an inactive substance). The study will measure changes in your motivation and brain activity to see if the treatment is successful. The study plans to enroll 60 participants, but its current recruitment status is unclear.

Study design: This interventional study plans to enroll 60 participants. It is a double-blinded study, meaning neither you nor your doctors will know if you are receiving infliximab or a placebo.
What's involved: You will have study visits before the intervention, and then 1 day, 3 days, 1 week, and 2 weeks after the intervention. These visits will involve tasks to measure motivation and blood tests for CRP.
Compensation: Not stated in the trial record.
Follow-up: You will be followed for up to 2 weeks after receiving the intervention to measure changes in motivation and C-reactive protein levels.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

Anti-Inflammatory Challenge in Schizophrenia

Recruiting

PHASE4Ages 18–55InterventionalBasic science

Emory University

~60 participants

Updated 2026-06-03 on ClinicalTrials.gov

What's tested:InfliximabPlacebo

At a glance

Recruiting sites

2 of 2 listed sites are recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Changes in Monetary Incentive Delay Task (MID)

Measured over Study visits: 1-3 days before intervention and 2 weeks post-intervention ]

+4 more outcomes measured

Conditions

Schizophrenia

Where it's being run

2 sites across 1 states

Georgia2

Study leadership

David R Goldsmith, MD · PRINCIPAL_INVESTIGATOR · Assistant Professor

Who to contact

David R Goldsmith, MD

[email protected]

404-727-3735

Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Men or women, 18-55 years of age with a primary diagnosis of Diagnostic and Statistical Manual of Mental Disorders (DSM-V) schizophrenia or schizoaffective disorder;

Willing and able to give written informed consent;

Plasma CRP ≥2 mg/L;

Significant motivational deficit as reflected by a score \>17 on the Motivation and Pleasure Domain of the Brief Negative Symptom Scale. Of note, for patients who exhibit CRP\>10mg/L, additional CRP testing will be conducted at 2-week intervals as per American Heart Association/ Center for Disease and Control Prevention guidelines to establish stability and rule out acute inflammation/infection (along with physical exam and laboratory testing).

Patients must also have a negative urine drug screen at all study visits.

Exclusion

Any autoimmune disorder (as confirmed by laboratory testing);

History of tuberculosis infection as determined by QuantiFERON Gold or high risk of tuberculosis exposure;

Active hepatitis B or C infection or human immunodeficiency virus infection (as established by laboratory testing);

History of any type of cancer;

History of fungal infection;

History of recurrent viral or bacterial infections;

Unstable cardiovascular (including evidence of congestive heart failure as determined by physical examination and laboratory testing), endocrinologic, hematologic, hepatic, renal, and neurological disease (as determined by physical examination and laboratory testing);

Demyelinating brain disease and/or a concerning structural abnormality seen on MRI;

Substance abuse/dependence within 6 months of study entry (as determined by MINI and urine drug screen);

Primary diagnosis of mood or anxiety disorder (i.e., major depressive disorder, bipolar disorder, post-traumatic stress disorder) as determined by the International Neuropsychiatric Interview for Schizophrenia and Psychotic Disorders (MINI).

Active suicidal ideation or plan;

An active eating disorder;

A history of cognitive disorder or Mini-Mental State Exam (MMSE) \< 24 (indicating cognitive impairment);

Pregnancy or lactation;

Treatment with clozapine (given increased risk of neutropenia/agranulocytosis);

Women of childbearing potential who are not using a medically accepted means of contraception;

Known allergy to murine products or other biologic therapies;

Previous organ transplant;

Administration of any modified live virus vaccine within one month of study entry, during the study, and for at least one month after the final study visit;

Oral glucocorticoids, immunosuppressive drugs (e.g. anti-cytokine therapies or methotrexate), or any other drugs targeting the immune system within 6 months of baseline;

Chronic use of non-steroidal anti-inflammatory agents (NSAIDs; excluding 81mg of aspirin), glucocorticoid-containing medications, or minocycline or non-prescription supplements with known or suspected anti-inflammatory properties (e.g. fish oil supplements, curcumin, pre- or probiotics) within 2 weeks of baseline or at any time during the study;

Use of non-steroidal anti-inflammatory agents (NSAIDs), and glucocorticoid medications at any time during the study;

Any contraindication to MRI. Due to the high co-morbidity between schizophrenia and mood/anxiety disorders, the study team plans to include patients with these diagnoses as long as schizophrenia is the primary diagnosis.

Subjects may be taking psychotropic medications at the time of the study (including antipsychotics, antidepressants, mood stabilizers, and benzodiazepines) but may have no psychotropic medication changes for one month before study enrollment or during participation in the study. Patients with stable medical conditions and on medications for those conditions will not be excluded. No patient will be removed from antipsychotic treatment for this study.

What this trial measures

Changes in Monetary Incentive Delay Task (MID)Study visits: 1-3 days before intervention and 2 weeks post-intervention ]
Change in Bold Oxygen Level Dependent (BOLD) Activation in the Ventral Striatum during "Win" Monetary Incentive Delay (MID) Task between Infliximab and Placebo (time frame:1-3 days before intervention and 2 weeks post intervention (MID occurs during scans). Activation response in ventral striatum in response to reward anticipation: Infliximab (vs placebo)-treated patients will exhibit a) increased activation in ventral striatum in response to reward. Mixed-effects models for repeated measures (MMRM) will first be employed to examine effects of group (infliximab vs. placebo), time and their interaction on blood oxygenation level-dependent (BOLD) signals (an index of regional brain activation) using a Region-of-Interest (ROI) approach.
Changes in Effort Based Decision Making Task (EBDM)1-3 days before intervention, 2 weeks post intervention
Changes in BOLD Activation response in anterior insula in response to increasing effort between Infliximab and Placebo (time frame:1-3 days before intervention and 2 weeks post intervention (EBDM occurs during scans) ). Activation response in insula in response to increasing effort: Infliximab (vs placebo)-treated patients will exhibit a) decreased activation in anterior insula in response to effort. Mixed-effects models for repeated measures (MMRM) will first be employed to examine effects of group (infliximab vs. placebo), time and their interaction on BOLD signals (an index of regional brain activation) using a Region-of-Interest (ROI) approach.
Changes in C-Reactive Protein (CRP)Study Visits :1-3 days before intervention, 1 day post-intervention, 3 days, 1 week and 2 weeks post-intervention
30ml study bloods per visit will be collected by venipuncture into EDTA-containing vacutainer tubes using standard sterile technique. Plasma for the evaluation of plasma concentrations of CRP will be obtained by centrifugation of whole blood at 1000 x g for 10 minutes at 4 C. Plasma CRP will be assessed with a high sensitivity turbidimetric assay. Assay sensitivity is rated at 0.18 mg/L, range of measure is 0.2 to 80 mg/L and functional sensitivity (at 20% CV) is 0.2 mg/L.
Changes in Brief Negative Symptom Scale (BNSS)1-3 days before intervention, 1 day, 3 days, 1 week, and 2 weeks post intervention
Infliximab (vs placebo) -treated patients will record their performance on the BNSS Motivation and Pleasure domain score. The BNSS is a 13-item scale designed for research studies in response to the 2005 National Institute of Mental Health (NIMH) consensus development conference on negative symptoms of schizophrenia.The BNSS measures the five commonly accepted domains of negative symptoms: blunted affect, alogia, asociality, anhedonia, and avolition. Items are scored on a 0 to 6 scale, with 0 indicating the symptom is absent and 6 indicating the symptom is severe. Items are summed for a total score that ranges between 0 and 78.
Changes in Performance on the Effort Expenditure for Reward Task (EEfRT)Study Visits :1-3 days before intervention and 2 weeks post intervention
Infliximab (vs placebo) -treated patients will be evaluated on their performance on the EEfRT. Assessment of reward motivation will be accomplished using an fMRI-adapted version of the EEfRT task. During each trial, subjects are presented with a choice between two levels of task difficulty, a High Effort option and a Low Effort option, which require different amounts of speeded manual button pressing for differing levels of monetary reward. The reward magnitude for a No Effort option remains constant , while the reward magnitude for the High Effort option will vary between 20%, 50%, 80%, and 100% of the subjects max effort (set for each individual prior to scan). The task will use a rapid event-related design with an exponential jitter between trials drawn in order to optimize hemodynamic response function estimation. Responses will be made using MRI-compatible button-boxes and images will be presented on a rear projection screen visible with a mirror mounted on the head coil.

Trialytics