Cognitive Dysfunction and Inflammation in Depression: Experimental Inhibition Via Infliximab

Exclusion Criteria

• •1. Medical conditions that could confound interpretation or increase participant risk, as indicated via medical history or laboratory testing; exclusionary medical conditions will include:
• •i. acute injury/infection within one week of study initiation or infection within one month of study initiation that required antibiotic/antiviral treatment ii. chronic infection (e.g., hepatitis B or C or HIV) or history of Covid 19 infection within the past 6 months or with persisting symptoms.
• •iii. latent infection (e.g., tuberculosis, fungal infections), or history of recurrent infections, iv. uncontrolled cardiovascular, endocrine, hematologic, hepatic, renal or neurologic disease (as determined by medical history, physical exam and laboratory testing) v. cancer history vi. autoimmune conditions; neurologic conditions (controlled) that are known to substantially impact cognitive function (e.g., stroke).
• •Of note, stable medical conditions such as diabetes and cardiovascular disease, will be allowed in the study as they can contribute to endogenous inflammation.
• •2. Active antipsychotic and anticonvulsant medication use (that interact with infliximab)
• •3. Prior use of a TNF antagonist or use of systemic corticosteroids or anti-proliferative agents within one year of study entry
• •4. History of liver abnormalities
• •5. Major cognitive impairment as determined by study investigators
• •6. Active restrictive eating disorder or obsessive compulsive disorder deemed by study investigators to be primary cause of depressive disorder
• •7. History of a psychotic disorder or Bipolar disorder type I/II
• •8. Current substance use disorder (i.e., present in last six months), of greater than mild severity
• •9. Suicidal ideation based on a score ≥3 on the Columbia-Suicide Severity Rating Scale
• •10. Electroconvulsive therapy (ECT)/deep brain stimulation (DBS) within the last year, or report of persistent negative cognitive effects of ECT/DBS
• •11. Presence of a transplanted solid organ
• •12. Medication use affecting immune or cognitive function:
• •i. Chronic use (\>1 month) of a benzodiazepine more than the equivalent of 2 mg of lorazepam ii. Use of anti-inflammatory agents during the study: non-steroidal anti-inflammatory agents (NSAIDs) (excluding 81mg of aspirin), glucocorticoid containing medicines or statins, or cyclooxygenase-2 (COX-2) inhibitors
• •13. Considered by the study investigators to be inappropriate for the study due to safety concerns or to be unlikely to complete the protocol
• •14. History of allergic response to murine products