Anti-Inflammatory Challenge in Schizophrenia

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Emory University
Study ID
NCT05823532
Phase
PHASE4
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Not accepted

Interventions

  • Infliximab — DRUG
    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.
  • Placebo — DRUG
    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.

Study Details

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 Dates

Start date
Apr 18, 2024
Status verified
Jun 2026
Primary completion
Mar 31, 2028
Completion
Mar 31, 2028

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Infliximab
    Subjects will be stratified by sex and randomized before this visit in preparation for the infusion. Vitals and safety labs will be drawn at this visit as well as urine testing for drugs of abuse and pregnancy testing for all biological females. Patients will receive breakfast followed by a double-blinded infusion of infliximab (5mg/kg body weight) in the GCSTA Clinical Research Center at Emory University Hospital. The infusion will last 2.5 hours, and subjects will be monitored during the infusion and for one hour after completion for the possible development of anaphylaxis, which occurs in less than 1% of patients receiving an initial dose of infliximab
  • Placebo Comparator: Placebo
    Subjects will be stratified by sex and randomized prior to this visit in preparation for the infusion. Vitals and safety labs will be drawn at this visit as well as urine testing for drugs of abuse and pregnancy testing for all biological females. Patients will receive breakfast followed by a double-blinded infusion of saline in the GCSTA Clinical Research Center at Emory University Hospital. The infusion will last 2- 2.5 hours, and subjects will be monitored during the infusion and for one hour after completion for the possible development of anaphylaxis, which occurs in less than 1% of patients receiving an initial dose of infliximab

Primary Outcome Measure

Changes in Monetary Incentive Delay Task (MID) [ Time Frame: Study visits: 1-3 days before intervention and 2 weeks post-intervention ] ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Emory University HospitalAtlantaGeorgia30322
David R Goldsmith, MD
[email protected]
404-727-3735
Grady Memorial HospitalAtlantaGeorgia30303
David R Goldsmith, MD
[email protected]
404-727-3735

Find similar trials in Atlanta, GA

By condition
Schizophrenia
By specialty
PsychiatryMental healthBehavioral health
By research site
Emory University Hospital· Atlanta, GAGrady Memorial Hospital· Atlanta, GA

Related Studies