Trials / Completed
CompletedNCT03093064
Inflammatory Response In Schizophrenia
The Role of Inflammation in Brain and Cognitive Function in Mental Disorders
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 66 (actual)
- Sponsor
- King's College London · Academic / Other
- Sex
- All
- Age
- 18 Years – 50 Years
- Healthy volunteers
- Accepted
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.
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Natalizumab | Natalizumab is a humanized monoclonal antibody against the cell adhesion molecule α4-integrin, currently licensed for the treatment of multiple sclerosis and Crohn's disease. |
| OTHER | Placebo: normal saline | Normal saline, intravenous infusion |
Timeline
- Start date
- 2017-04-01
- Primary completion
- 2023-06-15
- Completion
- 2023-08-07
- First posted
- 2017-03-28
- Last updated
- 2024-03-08
Locations
1 site across 1 country: United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03093064. Inclusion in this directory is not an endorsement.