Tests an anti-inflammatory drug's effect on motivation in schizophrenia
Tests infliximab against placebo in adults with schizophrenia to study motivation and brain reward.
Plain-language title generated from the registry record
Registry title: Anti-Inflammatory Challenge in Schizophrenia
Key facts
- Where
- Atlanta, United StatesSee the 2 sites
- Phase
- Phase 4
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 55 years old?
Source: NCT05823532, who can take part
Where in United States
- Emory University HospitalAtlanta, United StatesTaking people
- Grady Memorial HospitalAtlanta, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Emory University
- Trial code
- NCT05823532
- Record updated
- 3 June 2026
- Original description
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.Read full original descriptionShow less
Targeting Inflammation-Induced Changes in Brain Reward Signaling and Motivational Deficits in Patients With Schizophrenia Using an Anti-Inflammatory Challenge.
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.
Inclusion: Men or women, 18-55 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 ≥2 mg/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.
Exclusion: Substance abuse/dependence within 6 months of study entry (as determined by MINI and urine drug screen); Treatment with clozapine (given increased risk of neutropenia/agranulocytosis); 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; 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; History of tuberculosis infection as determined by QuantiFERON Gold or high risk of tuberculosis exposure; History of any type of cancer; History of fungal infection; History of recurrent viral or bacterial infections; Demyelinating brain disease and/or a concerning structural abnormality seen on MRI; 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); An active eating disorder; A history of cognitive disorder or Mini-Mental State Exam (MMSE) < 24 (indicating cognitive impairment); Known allergy to murine products or other biologic therapies; 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; Any autoimmune disorder (as confirmed by laboratory testing); Active hepatitis B or C infection or human immunodeficiency virus infection (as established by laboratory testing); 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); Active suicidal ideation or plan; Pregnancy or lactation; Women of childbearing potential who are not using a medically accepted means of contraception.