Inflammatory Response In Schizophrenia (IRIS)
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03093064 |
Recruitment Status :
Completed
First Posted : March 28, 2017
Last Update Posted : March 8, 2024
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Schizophrenia | Drug: Natalizumab Other: Placebo: normal saline | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 66 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | This is an experimental medicine study, the purpose of which is provide a mechanistic understanding of neuroinflammation in schizophrenia by investigating response to natalizumab (phase 1b). |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Basic Science |
Official Title: | The Role of Inflammation in Brain and Cognitive Function in Mental Disorders |
Actual Study Start Date : | April 1, 2017 |
Actual Primary Completion Date : | June 15, 2023 |
Actual Study Completion Date : | August 7, 2023 |
Arm | Intervention/treatment |
---|---|
Experimental: Patient Group: Natalizumab
Natalizumab 300mg, intravenous, once monthly, total of 3 doses
|
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 Name: Tysabri |
Placebo Comparator: Patient Group: Placebo
Saline, intravenous, once monthly, total of 3 doses
|
Other: Placebo: normal saline
Normal saline, intravenous infusion |
- Change in Translocator Protein (TSPO) availability pre- and post-natalizumab or placebo administration [ Time Frame: Baseline TSPO availability will be assessed at day -14 prior to first administration of natalizumab/placebo (day zero). TSPO availability will be re-assessed post administration of natalizumab/placebo at day +57(+14 days) ]TSPO availability assessed using Positron Emission Tomography (PET)
- Correlation of TSPO availability with brain functional measures at baseline. [ Time Frame: Baseline combined PET/MRI scan will be performed at day -14 prior to administration of natalizumab/placebo (day zero) ]Both TSPO availability (as measured using PET imaging) and brain functional measures (as measured using functional magnetic resonance imaging and magnetic resonance spectroscopy) will be measured simultaneously using a combined PET/MRI scanner.
- Correlation of cerebrospinal fluid (CSF) inflammatory markers with brain functional measures at baseline. [ Time Frame: Baseline PET/MRI scan will be performed at day -14 prior to administration of natalizumab/placebo (day zero). CSF collection will be performed between the time points day -14 to day -1 prior to administration of natalizumab/placebo (day zero). ]
Brain functional measures assessed using functional magnetic resonance imaging and magnetic resonance spectroscopy.
CSF inflammatory markers: measurements of cytokine concentrations (e.g. C-reactive protein, Interleukin-6)
- Correlation of blood inflammatory markers with brain functional measures at baseline. [ Time Frame: Baseline PET/MRI scan will be performed at day -14 prior to administration of natalizumab/placebo (day zero). Blood collection will be performed between the time points day -14 to day -1 prior to administration of natalizumab/placebo (day zero). ]
Brain functional measures assessed using functional magnetic resonance imaging and magnetic resonance spectroscopy.
Blood inflammatory markers: measurements of cytokine concentrations (e.g. C-reactive protein, Interleukin-6)
- Longitudinal change in TSPO availability correlated with longitudinal change in brain functional measures. [ Time Frame: Baseline combined PET/MRI scan will be performed at day -14 prior to administration of natalizumab/placebo (day zero). Repeat combined PET/MRI scan will be performed at day +57(+14 days). ]Both TSPO availability (as measured using PET imaging) and brain functional measures (as measured using functional magnetic resonance imaging and magnetic resonance spectroscopy) will be measured simultaneously using a combined PET/MRI scanner. There will be two separate scans - before and after administration of natalizumab/placebo.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 50 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03093064
United Kingdom | |
Institute of Psychiatry, Psychology and Neuroscience, King's College London | |
London, United Kingdom, SE5 8AF |
Principal Investigator: | Oliver D Howes | King's College London |
Responsible Party: | King's College London |
ClinicalTrials.gov Identifier: | NCT03093064 |
Other Study ID Numbers: |
208083 |
First Posted: | March 28, 2017 Key Record Dates |
Last Update Posted: | March 8, 2024 |
Last Verified: | March 2024 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | Yes |
Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders Mental Disorders |
Natalizumab Immunologic Factors Physiological Effects of Drugs |