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New treatment option for Schizophrenia
Official title Anti-Inflammatory Challenge in Schizophrenia
ClinicalTrials.gov ID: NCT05823532
What this study is testing
What is Infliximab?
Infliximab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for schizophrenia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 55
You may be able to join if
- Men or women, 18-55 years of age with a primary diagnosis of Diagnostic and Statistical Manual of Mental Disorders (DSM-V) schizophrenia or...
- 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 must also have a negative urine drug screen at all study visits.
You likely can't join if
- 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;
See the full eligibility 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...
- Patients must also have a negative urine drug screen at all study visits.
- 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...
- 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...
- 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...
- 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.
- people 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...
The study team makes the final eligibility decision.
Where it's taking place
- Atlanta, Georgia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 55 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Atlanta, Georgia, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.