Inflammatory Response In Schizophrenia

• Status: Recruiting
• Trial end date: 2022-03-31
• Target enrollment: 0
• Participant gender: All

Summary

Schizophrenia affects a significant proportion of the population and current levels of understanding of the illness is inadequate to treat it effectively. Converging lines of evidence suggest that neuroinflammation occurs in schizophrenia, and specifically over-activity of brain-resident immune cells called microglia. It is however unclear whether activated microglia play a primary role in schizophrenia, or whether this is a secondary phenomenon of no pathophysiological significance. The investigators therefore plan to test the effect of a monoclonal antibody (natalizumab) on psychotic symptoms in a cohort of first episode psychosis patients.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: King's College London
• Collaborator: South London and Maudsley NHS Foundation Trust
• Treatments: Natalizumab

Criteria

Inclusion criteria:

1. Aged 18-50 years

2. Diagnosis of schizophrenia or other psychotic disorder (Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5);

3. Symptomatic, defined as one or more positive symptom >3 AND one or more negative symptom >3 on the Positive and Negative Syndrome Scale (PANSS);

4. No acute relapse and psychiatrically stable for >1 month before screening;

Exclusion criteria:

1. 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).

2. Any absolute contraindications to natalizumab, as per natalizumab SPC

3. Current or recent (last 3 months) infection, or history of significant infection, or an immunocompromised state

4. Previous use of natalizumab or previous use of other monoclonal antibody.

5. Ongoing long-standing use of oral steroids or non-steroidal anti-inflammatory drugs.

6. Pregnancy and/or breast-feeding.

7. Substance dependence/abuse other than to cigarettes.