Phase 4 Schizophrenia Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• Adults between 18 and 55 years old who have been diagnosed with schizophrenia or schizoaffective disorder (as defined by standard diagnostic criteria)
• People who are willing and able to sign a written consent form to participate
• People whose blood test shows a C-reactive protein (CRP) level of 2 mg/L or higher — this is a marker of inflammation measured in a blood test
• People who show significant lack of motivation, as measured by a specific rating scale used in the trial (a score above 17 on the Motivation and Pleasure section of the Brief Negative Symptom Scale)
• People who return a negative urine drug screen at all study visits

Who may not be able to join:

• People who have an autoimmune disorder, confirmed by laboratory testing
• People with a history of tuberculosis infection, or who are considered at high risk of tuberculosis exposure, as determined by a specific blood test (QuantiFERON Gold)
• People with an active hepatitis B or C infection, or HIV, as confirmed by laboratory testing
• People with any history of cancer
• People with a history of a fungal infection
• People with a history of recurring viral or bacterial infections
• People with unstable heart, hormone, blood, liver, kidney, or neurological conditions, as determined by physical examination and laboratory testing
• People with a disease affecting the protective covering of nerve fibres in the brain (demyelinating disease), or a concerning finding on a brain MRI scan
• People who have had a substance use or dependence problem within the 6 months before entering the study, as determined by a clinical interview and urine drug screen
• People whose primary diagnosis is a mood or anxiety disorder such as major depression, bipolar disorder, or post-traumatic stress disorder — though people with these conditions alongside a primary diagnosis of schizophrenia may still be considered (confirm with trial site)
• People who are currently experiencing active thoughts of suicide or have an active plan to act on those thoughts
• People with an active eating disorder
• People with a history of a cognitive (thinking or memory) disorder, or who score below 24 on a standard cognitive assessment called the Mini-Mental State Exam
• People who are pregnant or currently breastfeeding
• People currently being treated with the antipsychotic medication clozapine
• Women who could become pregnant and are not using a medically accepted form of contraception
• People with a known allergy to products derived from mice or to other biologic therapies
• People who have previously had an organ transplant
• People who have received a live virus vaccine within one month before the study, or who would need one during the study or within one month after the final study visit
• People who have used oral steroids, immune-suppressing medications (such as anti-cytokine therapies or methotrexate), or other drugs targeting the immune system within the 6 months before the study starts
• People who have regularly used anti-inflammatory medications (NSAIDs, excluding low-dose 81mg aspirin), steroid-containing medications, minocycline, or supplements with known anti-inflammatory properties (such as fish oil, curcumin, or pre- or probiotics) within 2 weeks before the study starts, or at any time during the study
• People who would need to use NSAIDs or steroid medications at any point during the study
• People for whom an MRI scan would be unsafe or unsuitable
• People whose psychiatric medications have changed within the month before enrolling, or who would need a medication change during the study — note that people already on stable psychiatric medications (including antipsychotics, antidepressants, mood stabilisers, or benzodiazepines) may still be considered, as long as no changes are made (confirm with trial site)

Important: Always verify eligibility with the trial site directly before applying.