RightFit
RecruitingPhase 4

Anti-Inflammatory Challenge in Schizophrenia

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 55 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Visits mentioned: 11 visits
  • Procedures mentioned: MRI scans, Questionnaires, Physical exams, Heart tracing (ECG), Infusions, Blood draws

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Brain activity will be measured using functional magnetic resonance imaging (fMRI), and motivation will be assessed through behavioral tasks and questionnaires."
  • "Study procedures include eleven separate visits."
  • "The screening visit includes a physical exam, safety labs, MRI safety screening, and practice with a computer game designed to measure reward processing."
  • "The baseline visit includes behavioral assessments, an EKG, blood sampling, an fMRI scan during the reward game, and randomization to either infliximab or placebo."
  • "The infusion visit involves drug administration and safety checks."
  • "Follow-up visits occur at 24 hours, 3 days, 7 days, and 14 days post-infusion, with assessments of adverse events, behavioral performance, and vital signs."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how treatment to lower inflammation affects brain activity linked to rewards and effort. It is for adults with schizophrenia or schizoaffective disorder who have low motivation and signs of inflammation in their blood.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 18–55, with schizophrenia or schizoaffective disorder as your main diagnosis.
  • Willing and able to give written consent to join.
  • A blood CRP level of at least 2 mg/L. CRP is a sign of inflammation.
  • Major trouble with motivation, with a score above 17 on the study’s motivation and pleasure scale.
  • If CRP is above 10 mg/L, repeat blood tests every 2 weeks, plus an exam and lab tests, to check for infection or short-term inflammation.
  • A negative urine drug test at every study visit.
  • If taking medicines for mental health, no changes for 1 month before joining or during the study. You will not be taken off antipsychotic medicine for this study.
  • Stable medical conditions are allowed. Mood or anxiety disorders are allowed if schizophrenia is your main diagnosis.

Who can't join

  • An autoimmune disease, where the immune system attacks the body; past tuberculosis or high risk of exposure; active hepatitis B, hepatitis C, or HIV; past fungal infection; or repeated viral or bacterial infections.
  • Any past cancer or organ transplant; unstable heart, hormone, blood, liver, kidney, or nerve disease; brain disease that damages nerve coverings; a concerning brain structure seen on MRI; or any reason MRI is unsafe for you.
  • Drug or alcohol abuse or dependence within 6 months; a mood or anxiety disorder as your main diagnosis; current thoughts or plans of suicide; an active eating disorder; or a past thinking or memory disorder or a score below 24 on the study’s thinking test.
  • Pregnant, breastfeeding, or able to become pregnant but not using medically accepted birth control.
  • Taking clozapine, or a known allergy to mouse-derived products or other biologic treatments.
  • A modified live-virus vaccine within 1 month before joining, during the study, or for at least 1 month after the last visit.
  • Oral steroid medicines, medicines that weaken the immune system, or other immune-targeting drugs within 6 months before the starting visit.
  • Regular use of anti-inflammatory pain medicines such as ibuprofen (except 81 mg aspirin), steroid-containing medicines, minocycline, or supplements that may lower inflammation within 2 weeks before the starting visit or during the study. Examples include fish oil, curcumin, prebiotics, and probiotics. Anti-inflammatory pain medicines and steroid medicines are also barred at any time during the study.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * 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 Criteria: * 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.

Study sites (2)

GA