Inflammatory Response In Schizophrenia

One of the key aims of the study is to determine if there is a relationship between change in imaging inflammation markers from baseline to follow-up and changes in other markers of inflammation over the same period. In September 2021, an open label arm for natalizumab was added to the study. The relationship between changes in imaging inflammation markers and changes in other markers of inflammation will be analysed within subjects including all patients who received natalizumab.

Inclusion criteria

• Aged 18-50 years
• Diagnosis of schizophrenia or other psychotic disorder (Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5);
• Symptomatic, defined as one or more positive symptom >3 AND one or more negative symptom >3 on the Positive and Negative Syndrome Scale (PANSS);
• No acute relapse and psychiatrically stable for >1 month before screening;

Exclusion criteria

• History of significant co-morbid CNS disorder (including significant head trauma or significant loss of consciousness, Parkinson's Disease, Epilepsy, Alzheimer's Dementia, Huntington's Disease).
• Any absolute contraindications to natalizumab, as per natalizumab SPC
• Current or recent (last 3 months) infection, or history of significant infection, or an immunocompromised state
• Previous use of natalizumab or previous use of other monoclonal antibody.
• Ongoing long-standing use of oral steroids or non-steroidal anti-inflammatory drugs.
• Pregnancy and/or breast-feeding.
• Substance dependence/abuse other than to cigarettes.