Anti-Inflammatory Challenge in Schizophrenia

Recruiting now · Phase 4 · Has a placebo group

Conditions studied: Schizophrenia

In brief

This study aims to illuminate the biological underpinnings of negative symptoms in schizophrenia-particularly motivational impairments-by probing the link between systemic inflammation and neural activity in reward-related brain circuits. The primary goal of this study is to determine: * Ventral Striatum Activation: Assess how reward anticipation engages the ventral striatum in individuals with schizophrenia, both before and after an anti-inflammatory intervention. * Anterior Insula Activation: Examine how increasing effort demands modulate activity in the anterior insula under the same conditions.

Key facts

Study ID

NCT05823532

Run by

Emory University

People needed

60

Starts

2024-04-18

Expected to finish

2028-03-01

Last updated by the study team

2026-06-03

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Grady Memorial Hospital — Atlanta, Georgia, United States (enrolling)
• Emory University Hospital — Atlanta, Georgia, United States (enrolling)

Full record on ClinicalTrials.gov

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