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Clinical Trial
. 2023 Aug;130(8):1039-1048.
doi: 10.1007/s00702-022-02566-6. Epub 2022 Nov 19.

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

Wolfgang Strube  1 , Aslihan Aksar  1 , Ingrid Bauer  1 , Susana Barbosa  2 , Michael Benros  3 , Christiane Blankenstein  4 , Mattia Campana  5 , Laetitia Davidovic  2 , Nicolas Glaichenhaus  2 , Peter Falkai  5 , Thomas Görlitz  1 , Maximilian Hansbauer  1 , Daniel Heilig  6 , Olfa Khalfallah  2 , Marion Leboyer  7 , Emanuela Martinuzzi  2 , Susanne Mayer  6 , Joanna Moussiopoulou  5 , Irina Papazova  1 , Natasa Perić  6 , Elias Wagner  5 , Thomas Schneider-Axmann  5 , Judit Simon  6   8 , Alkomiet Hasan  9
Affiliations
Clinical Trial

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

Wolfgang Strube et al. J Neural Transm (Vienna). 2023 Aug.

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.

Keywords: Celecoxib; Inflammation; Precision medicine; Precision psychiatry; Schizophrenia; Targeted therapy.

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Conflict of interest statement

WS has received a speaker's honorarium from Mag&More GmbH and neurocare and was a member of the advisory board of Recordati. EW was a member of the advisory board of Recordati. PF is a co-editor of the German (DGPPN) Schizophrenia treatment guidelines and a co-author of the WFSBP schizophrenia treatment guidelines. He is on the advisory boards and receives speaker fees from Janssen, Lundbeck, Otsuka, Servier and Richter. AH is co-editor of the German (DGPPN) Schizophrenia treatment guidelines and first-author of the WFSBP schizophrenia treatment guidelines. He has been on the advisory boards and has received speaker fees from Janssen, Lundbeck and Otsuka. All other authors declare no competing financial interests.

Figures

Fig. 1
Fig. 1
Schematic representation of patient inclusion. Unsupervised classification methods will be used to stratify patients as “inflamed” and “non-inflamed” based on the serum levels of several cytokines. Only patients with an “inflamed profile” will enter the randomized-controlled part of the study and receive either Celecoxib or placebo twice daily
See this image and copyright information in PMC

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