Impact of Inflammation on Reward Circuits, Motivational Deficits and Negative Symptoms in Schizophrenia

• Status: Not yet recruiting
• Trial end date: 2023-04-01
• Target enrollment: 20
• Participant gender: All

Summary

The study is a prospective, placebo controlled, randomized study to evaluate the impact of an anti-inflammatory challenge (Infliximab Treatment) on reward circuitry, motivational deficits, and negative symptoms in a subset of Schizophrenia patients with high inflammation (C-reactive protein (CRP)>3 mg/L).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Emory University
• Collaborator: National Institute of Mental Health (NIMH)
• Treatments: Infliximab

Criteria

Inclusion Criteria:

• willing and able to give written informed consent;

• a primary diagnosis of Diagnostic and Statistical Manual -V schizophrenia or schizoaffective disorder as diagnosed by the Mini International Neuropsychiatric Interview for Schizophrenia and Psychotic Disorders (MINI) 6.0;

• Mini Mental Status Examination Score ≥24; e. no psychotropic medication changes for one month prior to study enrollment; may be taking other psychotropic non-antipsychotic medications (i.e., antidepressants, mood stabilizers, benzodiazepines);

• will have a CRP >3 mg/L.

Exclusion Criteria:Exclusion criteria will be split between those related to data quality and those related to subject safety. Data quality exclusion criteria may be waived at the discretion of the PI, though those exclusion criteria for subject safety may not be waived under any circumstances

• Data Quality Exclusion Criteria:

• evidence of untreated or poorly controlled endocrine, thyroid, cardiovascular, hematological, renal, neurological disease, hepatitis B or C or HIV;

• prior treatment with antiviral or immunomodulatory drugs, including corticosteroids within six months of study entry;

• current treatment with antibiotics;

• primary diagnosis of major depressive disorder or bipolar disorder;

• active abuse of alcohol or illicit/prescription drugs within the past 6 months including a urine toxicology screen positive for drugs of abuse;

• predominant left-handedness excluded for portions of the MRI scan;

• Wide Range Achievement Test-3 Reading Scale (WRAT-3) score indicating less than 8th grade reading level, unless otherwise approved by the PI or PI's designee;

• any other condition which in the opinion of the investigator would make the patient unsuitable for enrollment, or could interfere with participating in or completing the protocol.

• history of tuberculosis or high risk of tuberculosis exposure;

• history of fungal infection;

• history of any type of cancer;

• women of child bearing potential who are not using a medically accepted means of contraception;

• heterosexual males and their partners who do not agree to practice appropriate birth control;

• known allergy to murine products or other biologic therapies;

• previous organ transplant; h) treatment with clozapine (given increased risk of neutropenia/agranulocytosis).

• Subject Safety Exclusion Criteria:

• history of central nervous system trauma or active seizure disorder requiring medication;

• positive pregnancy test;

• presence of metal in the body;

• active suicidal ideation as determined by the PI and/or study staff.