RECRUITING

Anti-Inflammatory Challenge in Schizophrenia

Conditions

Schizophrenia Inflammation Reward-related Brain Regions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This research project will explore negative symptoms of schizophrenia, such as motivational deficits, by examining the relationship between inflammation and reward-related brain regions. To accomplish this, we will administer a single infusion of either the anti-inflammatory medication infliximab or placebo (n=10 per group) to patients with high inflammation. This study is important because schizophrenia can be a chronic and debilitating neuropsychiatric disorder and negative symptoms are some of the most difficult aspects of schizophrenia associated with worst functional outcomes. These symptoms do not typically respond to antipsychotic therapies, and as such, there are no current medications to treat negative symptoms.

Official Title

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

Quick Facts

Study Start:2024-04-18

Study Completion:2028-03

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05823532

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 45 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT

Inclusion Criteria	Exclusion Criteria
* Men or women, 18-45 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 3mg/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.	* 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.

Inclusion Criteria

Exclusion Criteria

* Men or women, 18-45 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 3mg/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.

* 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.

Contacts and Locations

Study Contact

David R Goldsmith, MD

CONTACT

404-727-3735

drgolds@emory.edu

Principal Investigator

David R Goldsmith, MD

PRINCIPAL_INVESTIGATOR

Assistant Professor

Study Locations (Sites)

Grady Memorial Hospital

Atlanta, Georgia, 30303

United States

Emory University Hospital

Atlanta, Georgia, 30322

United States

Collaborators and Investigators

Sponsor: Emory University

David R Goldsmith, MD, PRINCIPAL_INVESTIGATOR, Assistant Professor

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-04-18

Study Completion Date2028-03

Study Record Updates

Study Start Date2024-04-18

Study Completion Date2028-03

Terms related to this study

Keywords Provided by Researchers

Inflammation
Reward-related Brain Regions

Additional Relevant MeSH Terms

Schizophrenia