RecruitingPhase 4NCT05823532

Anti-Inflammatory Challenge in Schizophrenia

Targeting Inflammation-Induced Changes in Brain Reward Signaling and Motivational Deficits in Patients With Schizophrenia Using an Anti-Inflammatory Challenge.

Sponsor

Emory University

Enrollment

60 participants

Start Date

Apr 18, 2024

Study Type

INTERVENTIONAL

Conditions

Schizophrenia

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 55 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether giving an anti-inflammatory drug can help reduce motivation problems (a symptom called amotivation or negative symptoms) in people with schizophrenia or schizoaffective disorder who have elevated levels of a blood marker of inflammation (CRP). Some research suggests that brain inflammation may contribute to the flat affect and low motivation seen in schizophrenia. **You may be eligible if...** - You are between 18 and 45 years old - You have a diagnosis of schizophrenia or schizoaffective disorder - You have significant motivational problems (score above 17 on a standard scale) - Your blood CRP level is elevated (above 3 mg/L), suggesting active inflammation **You may NOT be eligible if...** - You have very high CRP levels suggesting another active medical illness - You have a condition that prevents the use of the anti-inflammatory drug - You have had a recent serious infection or surgery - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGInfliximab

Infliximab has FDA approval for the treatment of rheumatoid arthritis and inflammatory bowel syndrome. The current proposal represents the use of infliximab as an experimental tool to dissect the role of inflammatory processes leading to changes in brain reward circuitry and changes in specific symptom domains. Double-blinded infusions of infliximab will be administered in the GCTSA Clinical Research Center, located at Emory University Hospital. Independent pharmacists will dispense either infliximab or placebo in a 250ml saline bag according to a computer-generated randomization list provided by the study pharmacist.

DRUGPlacebo

Double-blinded infusions of saline will be administered in the GCTSA Clinical Research Center, located at Emory University Hospital. Independent pharmacists will dispense either infliximab or placebo in a 250ml saline bag according to a computer-generated randomization list provided by the study pharmacist.