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NCT03093064: IRIS

Inflammatory Response In Schizophrenia

Completed Phase 1 Last updated 8 March 2024
What this trial tests

Phase 1 trial testing Natalizumab in Schizophrenia in 66 participants. Completed in 7 August 2023.

Timeline
1 April 2017
Primary endpoint
15 June 2023
7 August 2023

Quick facts

Lead sponsorKing's College London
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposebasic science
Enrollment66
Start date1 April 2017
Primary completion15 June 2023
Estimated completion7 August 2023
Sites1 location across United Kingdom

Drugs / interventions tested

Conditions studied

Sponsor

King's College London

Who can join

Adults 18 to 50, any sex, with Schizophrenia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Anti-inflammatory Strategies for Schizophrenia: A Review of Evidence for Therapeutic Applications and Drug Repurposing.
    Hong J, Bang M. · · 2020 · cited 61× · PMID 31958901 · DOI 10.9758/cpn.2020.18.1.10
  2. Obesity and the Brain.
    Karczewski J, Zielińska A, Staszewski R, Eder P, et al · · 2022 · cited 13× · PMID 35682824 · DOI 10.3390/ijms23116145
  3. Peripheral inflammation is associated with reduced influx of TSPO PET tracers into the brain: insights from a non-invasive mapping methodology
    Barzon L, Maccioni L, Moretto M, Giacomel A, et al · · 2025 · cited 2× · DOI 10.21203/rs.3.rs-6648321/v2
  4. Network-based disease fingerprinting with neuroinflammation PET imaging.
    Barzon L, Maccioni L, Carranza Mellana M, Schubert JJ, et al · · 2026 · PMID 41957656 · DOI 10.1186/s12974-026-03788-1
  5. Immune alterations in schizophrenia and the effects of a therapeutic antibody: a neuroimaging study.
    Mizuno Y, Carreira Figueiredo I, Pillinger T, Hindley G, et al · · 2026 · PMID 41326319 · DOI 10.1093/brain/awaf455
  6. Network-based disease fingerprinting with neuroinflammation PET imaging
    Barzon L, Maccioni L, Mellana MC, Schubert JJ, et al · · 2025 · DOI 10.21203/rs.3.rs-7887022/v1
  7. 412. TARGETING MICROGLIAL ACTIVATION IN SCHIZOPHRENIA: A LONGITUDINAL [18F]DPA-714 PET IMAGING STUDY INVESTIGATING THE EFFECTS OF A 3-MONTH TREATMENT WITH NATALIZUMAB
    · 2025
  8. Peripheral inflammation is associated with reduced influx of TSPO PET tracers into the brain: insights from a non-invasive mapping methodology
    Barzon L, Maccioni L, Moretto M, Giacomel A, et al · · 2025 · DOI 10.21203/rs.3.rs-6648321/v1

Verify or expand the search:

Other trials of Natalizumab

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