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

被引：6

作者：

Strube, Wolfgang ^{[1
]}

Aksar, Aslihan ^{[1
]}

Bauer, Ingrid ^{[1
]}

Barbosa, Susana ^{[2
]}

Benros, Michael ^{[3
]}

Blankenstein, Christiane ^{[4
]}

Campana, Mattia ^{[5
]}

Davidovic, Laetitia ^{[2
]}

Glaichenhaus, Nicolas ^{[2
]}

Falkai, Peter ^{[5
]}

Gorlitz, Thomas ^{[1
]}

Hansbauer, Maximilian ^{[1
]}

Heilig, Daniel ^{[7
]}

Khalfallah, Olfa ^{[2
]}

Leboyer, Marion ^{[6
]}

Martinuzzi, Emanuela ^{[2
]}

Mayer, Susanne ^{[7
]}

Moussiopoulou, Joanna ^{[5
]}

Papazova, Irina ^{[1
]}

Peric, Natasa ^{[7
]}

Wagner, Elias ^{[5
]}

Schneider-Axmann, Thomas ^{[5
]}

Simon, Judit ^{[7
,8
]}

Hasan, Alkomiet ^{[1
]}

机构：

[1] Univ Augsburg, Dept Psychiat Psychotherapy & Psychosomat, Med Fac, Bezirkskrankenhaus Augsburg,Geschwister Schonert, D-86156 Augsburg, Germany

[2] Univ Cote Azur, Inst Pharmacol Mol & Cellulaire, Ctr Natl Rech Sci, Valbonne, France

[3] Copenhagen Univ Hosp, Copenhagen Res Ctr Mental Hlth, Mental Hlth Ctr Copenhagen, CORE, Copenhagen, Denmark

[4] Tech Univ Munich, Sch Med, Munchner Studienzentrum, Munich, Germany

[5] Ludwig Maximilians Univ Munchen, Univ Hosp, Dept Psychiat & Psychotherapy, Munich, Germany

[6] Univ Paris Est Creteil, Psychiat Lab,INSERM U955,IMRB,Translat Neuro Psyc, Hop Univ Henri Mondor,AP HP,FHU ADAPT, Dept Med Univ Psychiat Addictol DMU IMPACT, F-94010 Creteil, France

[7] Med Univ Vienna, Ctr Publ Hlth, Dept Hlth Econ, Vienna, Austria

[8] Univ Oxford, Dept Psychiat, Oxford, England

来源：

JOURNAL OF NEURAL TRANSMISSION | 2023年 / 130卷 / 08期

基金：

奥地利科学基金会;

关键词：

Schizophrenia; Inflammation; Celecoxib; Precision medicine; Targeted therapy; Precision psychiatry; HEALTH; ANTIPSYCHOTICS; METAANALYSIS; EFFICACY; SAFETY; SCALE; DRUG;

D O I：

10.1007/s00702-022-02566-6

中图分类号：

R74 [神经病学与精神病学];

学科分类号：

摘要：

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.

引用

页码：1039 / 1048

页数：10

共 42 条

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