Abstract
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.
| Originalsprog | Engelsk |
|---|---|
| Tidsskrift | Journal of Neural Transmission |
| Vol/bind | 130 |
| Sider (fra-til) | 1039–1048 |
| ISSN | 0300-9564 |
| DOI | |
| Status | Udgivet - 2023 |
Bibliografisk note
Funding Information:This study is supported by the Federal Ministry of Education and Research (Bundesministerium für Bildung und Forschung, BMBF) under the project title “PerMedSchiz: Personalized medical treatment for schizophrenia“ (Funding reference number: 01KU2002), and the Innovation Fund Denmark (Funding reference number: 9088-00002B). The health economic analyses are supported by the Austrian Science Fund (Wissenschaftsfonds, FWF) under the project title “Personalized medicine in schizophrenia (PerMedSchiz)“ (Funding reference number: I 4725-B). The funders have no role in the design and conduct of the study, the collection and management of the data as well as their respective analysis and the preparation or approval of the manuscript.
Publisher Copyright:
© 2022, The Author(s).
Finansiering
This study is supported by the Federal Ministry of Education and Research (Bundesministerium für Bildung und Forschung, BMBF) under the project title “PerMedSchiz: Personalized medical treatment for schizophrenia“ (Funding reference number: 01KU2002), and the Innovation Fund Denmark (Funding reference number: 9088-00002B). The health economic analyses are supported by the Austrian Science Fund (Wissenschaftsfonds, FWF) under the project title “Personalized medicine in schizophrenia (PerMedSchiz)“ (Funding reference number: I 4725-B). The funders have no role in the design and conduct of the study, the collection and management of the data as well as their respective analysis and the preparation or approval of the manuscript.
Citationsformater
- APA
- Standard
- Harvard
- Vancouver
- Author
- BIBTEX
- RIS