PAFIP_TLR
Retrospective and Prospective Study of the Activation of Proinflammatory Pathways of Toll-like Receptors in Patients With Schizophrenia: a Comparative Effect of Risperidone vs Aripiprazole
Sponsor study identifier
observational
150
1 country
1
Study Start
August 2016
Actual (reported)Primary Completion
December 2018
Actual (reported)Study Completion
March 2019
Actual (reported)The study of immune pathways involved in the etiopathogeny of schizophrenia would be an important advance to understand the mechanisms involved in the development of this disease and it would be a turning point in drug therapy. Until now, the mechanism of action of antipsychotics focused on the blockade or modulation of brain dopaminergic pathways. If immunological pathways responsible for neuroinflammation and neurodegeneration which involve alterations in different areas and brain pathways (including dopaminergic pathways) are discovered, investigators could develop new treatments that act on these new targets, allowing to delay the onset of the first psychotic episode and improve the evolution and impact of this disease.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 2019
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 2016
Actual (reported)September 7, 2016
Actual (reported)September 13, 2016
Actual (reported)December 2018
Actual (reported)March 2019
Actual (reported)Measure the expression of proinflammatory molecules of activation pathways of TLRs in patients and controls using the Luminex xMAP technology: a comparative effect of Risperidone vs Aripiprazole.
The Milliplex Human High Sensitivity T Cell Magnetic Bead Kit will be used to analyze the proinflammatory molecules. This kit includes response cytokines (Th1, Th2, Th17 and regulatory) and cytokines secreted by macrophage cells and myeloid lineage. It allows a balance of pro and anti-inflammatory cytokines. Luminex is an automated flow cytometer with an open technology that allows various tests to measure different biological parameters, reducing time, handling and cost overruns compared to more traditional methods such as Western Blot, enzyme-linked immunosorbent assay (ELISA) or traditional protein arrays. The methodology uses tests in the microsphere surface or magnetic beads of 5.6 um diameter which emit fluorescence and it is detected in a compact analyzer (Luminex).
3 months
Assessment the expression of genes encoding proinflammatory pathways of TLRs in patients and controls using the Luminex xMAP technology.
3 months
Measure the functionality of proinflammatory pathways of TLRs in patients and controls after direct cell stimulation.
3 months
Compare the long-term evolution of patients with varying degrees of activation of immune system using the Luminex xMAP technology.
3 years
Individuals included in the First Episode Psychosis Clinical Program (PAFIP) between June 2011 and February 2016. Retrospective study of frozen samples: samples at baseline and 3 months will be analyzed.
Individuals included in the First Episode Psychosis Clinical Program (PAFIP) between September 2016 and September 2017. Prospective study of fresh samples: samples at baseline and 3 months will be analyzed.
Healthy subjects without psychotic disorder.
Frozen samples of serum and peripheral blood mononuclear cell (PBMC) stored in the Biobank Valdecilla will be selected.
Samples of serum and cells will be drawn.
Individuals included in the First Episode Psychosis Clinical Program (PAFIP) at the University Hospital Marqués de Valdecilla (Santander - Cantabria, Spain) between June 2011 and September 2017.
University Hospital Marqués de Valdecilla
Santander, Cantabria, 39008, Spain
Pardo-de-Santayana G, Juncal-Ruiz M, Vazquez-Bourgon J, Riesco-Davila L, Ortiz-Garcia de la Foz V, Pelayo-Teran JM, Lopez-Hoyos M, Crespo-Facorro B. Active psychosis and pro-inflammatory cytokines in first-episode of psychosis. J Psychiatr Res. 2021 Feb;134:150-157. doi: 10.1016/j.jpsychires.2020.12.060. Epub 2020 Dec 22.
Serum and peripheral blood mononuclear cell (PBMC)
Benedicto Crespo-Facorro, Professor
University Hospital Marqués de Valdecilla, IDIVAL, Department of Psychiatry, School of Medicine, University of Cantabria, Santander, Spain. CIBERSAM Centro Investigación Biomédica en Red Salud Mental, Madrid, Spain
150 participants (actual enrollment reported by the registry).
First Submitted
September 7, 2016
First Posted
September 13, 2016
Study Start
August 2016
Actual (reported)Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
December 2018
Actual (reported)Study Completion
March 2019
Actual (reported)Last Updated
February 17, 2020
Record last verified: 2019-03
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Source: ClinicalTrials.gov.
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