Psychosis-Associated Neuroinflammation in Schizophrenia

Exclusion Criteria

• •Use of nonsteroidal antiinflammatory drugs, paracetamol, immunosuppressant or immunostimulating drugs within 21 days of screening.
• •Use of systemic corticosteroids within 21 days of screening.
• •Has a history of drug or alcohol dependence according to DSM-V criteria, except nicotine or caffeine, within 6 months before screening.
• •Has history of (co-morbid) somatization or mood disorder according to DSM-V criteria within 6 months before screening.
• •Has a positive test result for drugs of abuse or for alcohol at screening or test day.
• •Female subjects only: is pregnant or breastfeeding
• •Has a history of chronic or acute physical illness associated with abnormal immune changes within the 2 weeks before the study.
• •Leukocytosis (i.e., white blood cell count ≤ 11 x109 /L) on screening and test days.
• •Serology positive for hepatitis B surface antigen (HBsAg), hepatitis C antibodies, or HIV antibodies at screening.
• •Has a medical history of any auto-immune disorder or chronic inflammatory disease.
• •Has received electroconvulsive therapy in the last 6 months.
• •Is currently enrolled in a study with an investigational study drug.
• •Worsening or first time occurrence of significant suicidality
• •Has donated blood within 3 months before screening.
• •Has any condition that, in the opinion of the investigator, would compromise the wellbeing of the subject or the study or prevent the subject from meeting or performing study requirements.
• •Low affinity binder of the TSPO, as determined by rs6971 polymorphism genotyping at Screening
• •Use of benzodiazepines for 3x the half-life prior to PET-scan
• •Presence of irremovable magnetic materials in or on the body
• •Has a medical history of organic brain disease
• •Has a medical history of traumatic brain injury
• •Has a medical history of allergic reaction to any of the substances in the tracer fluid.
• •Unwillingness or inability of subject to undergo PET and/or MRI scan (for example due to claustrophobia or lack of cooperation)
• •Healthy volunteers:
• •Personal history of psychotic disorder
• •Family history of psychotic or bipolar disorder in first-degree relatives
• •Family history of auto-immune disorder in first-degree relatives
• •Schizophrenia patients:
• •\- Calgary Depression Scale for Schizophrenia (CDSS) score \>6 at screening