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Effects of add-on Celecoxib treatment on patients with schizophrenia spectrum disorders and inflammatory cytokine profile trial (TargetFlame): study design and methodology of a multicentre randomized, placebo-controlled trial

Neuroinflammation has been proposed to impact symptomatology in patients with schizophrenia spectrum disorders. While previous studies have shown equivocal effects of treatments with add-on anti-inflammatory drugs such as Aspirin, N-acetylcysteine and Celecoxib, none have used a subset of prospectiv...

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Autores principales: Strube, Wolfgang, Aksar, Aslihan, Bauer, Ingrid, Barbosa, Susana, Benros, Michael, Blankenstein, Christiane, Campana, Mattia, Davidovic, Laetitia, Glaichenhaus, Nicolas, Falkai, Peter, Görlitz, Thomas, Hansbauer, Maximilian, Heilig, Daniel, Khalfallah, Olfa, Leboyer, Marion, Martinuzzi, Emanuela, Mayer, Susanne, Moussiopoulou, Joanna, Papazova, Irina, Perić, Natasa, Wagner, Elias, Schneider-Axmann, Thomas, Simon, Judit, Hasan, Alkomiet
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer Vienna 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10374797/
https://www.ncbi.nlm.nih.gov/pubmed/36401749
http://dx.doi.org/10.1007/s00702-022-02566-6
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author Strube, Wolfgang
Aksar, Aslihan
Bauer, Ingrid
Barbosa, Susana
Benros, Michael
Blankenstein, Christiane
Campana, Mattia
Davidovic, Laetitia
Glaichenhaus, Nicolas
Falkai, Peter
Görlitz, Thomas
Hansbauer, Maximilian
Heilig, Daniel
Khalfallah, Olfa
Leboyer, Marion
Martinuzzi, Emanuela
Mayer, Susanne
Moussiopoulou, Joanna
Papazova, Irina
Perić, Natasa
Wagner, Elias
Schneider-Axmann, Thomas
Simon, Judit
Hasan, Alkomiet
author_facet Strube, Wolfgang
Aksar, Aslihan
Bauer, Ingrid
Barbosa, Susana
Benros, Michael
Blankenstein, Christiane
Campana, Mattia
Davidovic, Laetitia
Glaichenhaus, Nicolas
Falkai, Peter
Görlitz, Thomas
Hansbauer, Maximilian
Heilig, Daniel
Khalfallah, Olfa
Leboyer, Marion
Martinuzzi, Emanuela
Mayer, Susanne
Moussiopoulou, Joanna
Papazova, Irina
Perić, Natasa
Wagner, Elias
Schneider-Axmann, Thomas
Simon, Judit
Hasan, Alkomiet
author_sort Strube, Wolfgang
collection PubMed
description Neuroinflammation has been proposed to impact symptomatology in patients with schizophrenia spectrum disorders. While previous studies have shown equivocal effects of treatments with add-on anti-inflammatory drugs such as Aspirin, N-acetylcysteine and Celecoxib, none have used a subset of prospectively recruited patients exhibiting an inflammatory profile. The aim of the study is to evaluate the efficacy and safety as well as the cost-effectiveness of a treatment with 400 mg Celecoxib added to an ongoing antipsychotic treatment in patients with schizophrenia spectrum disorders exhibiting an inflammatory profile. The “Add-on Celecoxib treatment in patients with schizophrenia spectrum disorders and inflammatory cytokine profile trial (TargetFlame)” is a multicentre randomized, placebo-controlled phase III investigator-initiated clinical trial with the following two arms: patients exhibiting an inflammatory profile receiving either add-on Celecoxib 400 mg/day or add-on placebo. A total of 199 patients will be assessed for eligibility by measuring blood levels of three pro-inflammatory cytokines, and 109 patients with an inflammatory profile, i.e. inflamed, will be randomized, treated for 8 weeks and followed-up for additional four months. The primary endpoint will be changes in symptom severity as assessed by total Positive and Negative Syndrome Scale (PANSS) score changes from baseline to week 8. Secondary endpoints include various other measures of psychopathology and safety. Additional health economic analyses will be performed. TargetFlame is the first study aimed at evaluating the efficacy, safety and cost-effectiveness of the antiphlogistic agent Celecoxib in a subset of patients with schizophrenia spectrum disorders exhibiting an inflammatory profile. With TargetFlame, we intended to investigate a novel precision medicine approach towards anti-inflammatory antipsychotic treatment augmentation using drug repurposing. Clinical trial registration: http://www.drks.de/DRKS00029044 and https://trialsearch.who.int/Trial2.aspx?TrialID=DRKS00029044
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spelling pubmed-103747972023-07-29 Effects of add-on Celecoxib treatment on patients with schizophrenia spectrum disorders and inflammatory cytokine profile trial (TargetFlame): study design and methodology of a multicentre randomized, placebo-controlled trial Strube, Wolfgang Aksar, Aslihan Bauer, Ingrid Barbosa, Susana Benros, Michael Blankenstein, Christiane Campana, Mattia Davidovic, Laetitia Glaichenhaus, Nicolas Falkai, Peter Görlitz, Thomas Hansbauer, Maximilian Heilig, Daniel Khalfallah, Olfa Leboyer, Marion Martinuzzi, Emanuela Mayer, Susanne Moussiopoulou, Joanna Papazova, Irina Perić, Natasa Wagner, Elias Schneider-Axmann, Thomas Simon, Judit Hasan, Alkomiet J Neural Transm (Vienna) Psychiatry and Preclinical Psychiatric Studies - Original Article Neuroinflammation has been proposed to impact symptomatology in patients with schizophrenia spectrum disorders. While previous studies have shown equivocal effects of treatments with add-on anti-inflammatory drugs such as Aspirin, N-acetylcysteine and Celecoxib, none have used a subset of prospectively recruited patients exhibiting an inflammatory profile. The aim of the study is to evaluate the efficacy and safety as well as the cost-effectiveness of a treatment with 400 mg Celecoxib added to an ongoing antipsychotic treatment in patients with schizophrenia spectrum disorders exhibiting an inflammatory profile. The “Add-on Celecoxib treatment in patients with schizophrenia spectrum disorders and inflammatory cytokine profile trial (TargetFlame)” is a multicentre randomized, placebo-controlled phase III investigator-initiated clinical trial with the following two arms: patients exhibiting an inflammatory profile receiving either add-on Celecoxib 400 mg/day or add-on placebo. A total of 199 patients will be assessed for eligibility by measuring blood levels of three pro-inflammatory cytokines, and 109 patients with an inflammatory profile, i.e. inflamed, will be randomized, treated for 8 weeks and followed-up for additional four months. The primary endpoint will be changes in symptom severity as assessed by total Positive and Negative Syndrome Scale (PANSS) score changes from baseline to week 8. Secondary endpoints include various other measures of psychopathology and safety. Additional health economic analyses will be performed. TargetFlame is the first study aimed at evaluating the efficacy, safety and cost-effectiveness of the antiphlogistic agent Celecoxib in a subset of patients with schizophrenia spectrum disorders exhibiting an inflammatory profile. With TargetFlame, we intended to investigate a novel precision medicine approach towards anti-inflammatory antipsychotic treatment augmentation using drug repurposing. Clinical trial registration: http://www.drks.de/DRKS00029044 and https://trialsearch.who.int/Trial2.aspx?TrialID=DRKS00029044 Springer Vienna 2022-11-19 2023 /pmc/articles/PMC10374797/ /pubmed/36401749 http://dx.doi.org/10.1007/s00702-022-02566-6 Text en © The Author(s) 2022 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) .
spellingShingle Psychiatry and Preclinical Psychiatric Studies - Original Article
Strube, Wolfgang
Aksar, Aslihan
Bauer, Ingrid
Barbosa, Susana
Benros, Michael
Blankenstein, Christiane
Campana, Mattia
Davidovic, Laetitia
Glaichenhaus, Nicolas
Falkai, Peter
Görlitz, Thomas
Hansbauer, Maximilian
Heilig, Daniel
Khalfallah, Olfa
Leboyer, Marion
Martinuzzi, Emanuela
Mayer, Susanne
Moussiopoulou, Joanna
Papazova, Irina
Perić, Natasa
Wagner, Elias
Schneider-Axmann, Thomas
Simon, Judit
Hasan, Alkomiet
Effects of add-on Celecoxib treatment on patients with schizophrenia spectrum disorders and inflammatory cytokine profile trial (TargetFlame): study design and methodology of a multicentre randomized, placebo-controlled trial
title Effects of add-on Celecoxib treatment on patients with schizophrenia spectrum disorders and inflammatory cytokine profile trial (TargetFlame): study design and methodology of a multicentre randomized, placebo-controlled trial
title_full Effects of add-on Celecoxib treatment on patients with schizophrenia spectrum disorders and inflammatory cytokine profile trial (TargetFlame): study design and methodology of a multicentre randomized, placebo-controlled trial
title_fullStr Effects of add-on Celecoxib treatment on patients with schizophrenia spectrum disorders and inflammatory cytokine profile trial (TargetFlame): study design and methodology of a multicentre randomized, placebo-controlled trial
title_full_unstemmed Effects of add-on Celecoxib treatment on patients with schizophrenia spectrum disorders and inflammatory cytokine profile trial (TargetFlame): study design and methodology of a multicentre randomized, placebo-controlled trial
title_short Effects of add-on Celecoxib treatment on patients with schizophrenia spectrum disorders and inflammatory cytokine profile trial (TargetFlame): study design and methodology of a multicentre randomized, placebo-controlled trial
title_sort effects of add-on celecoxib treatment on patients with schizophrenia spectrum disorders and inflammatory cytokine profile trial (targetflame): study design and methodology of a multicentre randomized, placebo-controlled trial
topic Psychiatry and Preclinical Psychiatric Studies - Original Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10374797/
https://www.ncbi.nlm.nih.gov/pubmed/36401749
http://dx.doi.org/10.1007/s00702-022-02566-6
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