Evidence map›Paper›PMID 36401749›Full record

ArticleJournal of neural transmission (Vienna, Austria : 1996)2023

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, Aslihan Aksar, Ingrid Bauer, Susana Barbosa, Michael Benros, Christiane Blankenstein, Mattia Campana, Laetitia Davidovic, Nicolas Glaichenhaus, Peter Falkai and 14 more

Open access · hybridAbstract readClinical Trial Protocol
In one paragraph

Article in Journal of neural transmission (Vienna, Austria : 1996), 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
0.5field-weighted citation impact, top 46% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 9 citations in OpenAlex.

  1. Review
  2. Review
  3. Review
  4. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

24 authors at 10 institutions in 5 countries.

Wolfgang StrubeDepartment of Psychiatry, Psychotherapy, and Psychosomatics, Medical Faculty, University of Augsburg, Bezirkskrankenhaus Augsburg, Geschwister-Schönert-Str. 1, 86156, Augsburg, Germany.
Aslihan AksarDepartment of Psychiatry, Psychotherapy, and Psychosomatics, Medical Faculty, University of Augsburg, Bezirkskrankenhaus Augsburg, Geschwister-Schönert-Str. 1, 86156, Augsburg, Germany.
Ingrid BauerDepartment of Psychiatry, Psychotherapy, and Psychosomatics, Medical Faculty, University of Augsburg, Bezirkskrankenhaus Augsburg, Geschwister-Schönert-Str. 1, 86156, Augsburg, Germany.
Susana BarbosaInstitut de Pharmacologie Moléculaire et Cellulaire, Université Côte d'Azur, Centre National de La Recherche Scientifique, Valbonne, France.
Michael BenrosCORE-Copenhagen Research Centre for Mental Health, Mental Health Centre Copenhagen, Copenhagen University Hospital, Copenhagen, Denmark.
Christiane BlankensteinMünchner Studienzentrum, School of Medicine, Technical University of Munich, Munich, Germany.
Mattia CampanaDepartment of Psychiatry and Psychotherapy, University Hospital, LMU Munich, Munich, Germany.
Laetitia DavidovicInstitut de Pharmacologie Moléculaire et Cellulaire, Université Côte d'Azur, Centre National de La Recherche Scientifique, Valbonne, France.
Nicolas GlaichenhausInstitut de Pharmacologie Moléculaire et Cellulaire, Université Côte d'Azur, Centre National de La Recherche Scientifique, Valbonne, France.
Peter FalkaiDepartment of Psychiatry and Psychotherapy, University Hospital, LMU Munich, Munich, Germany.
Thomas GörlitzDepartment of Psychiatry, Psychotherapy, and Psychosomatics, Medical Faculty, University of Augsburg, Bezirkskrankenhaus Augsburg, Geschwister-Schönert-Str. 1, 86156, Augsburg, Germany.
Maximilian HansbauerDepartment of Psychiatry, Psychotherapy, and Psychosomatics, Medical Faculty, University of Augsburg, Bezirkskrankenhaus Augsburg, Geschwister-Schönert-Str. 1, 86156, Augsburg, Germany.
Daniel HeiligDepartment of Health Economics, Center for Public Health, Medical University of Vienna, Vienna, Austria.
Olfa KhalfallahInstitut de Pharmacologie Moléculaire et Cellulaire, Université Côte d'Azur, Centre National de La Recherche Scientifique, Valbonne, France.
Marion LeboyerUniv Paris Est Créteil, INSERM U955, IMRB, Translational Neuro-Psychiatry Laboratory, AP-HP, Hôpitaux Universitaires Henri Mondor, Département Médico-Universitaire de Psychiatrie Et d'Addictologie (DMU IMPACT), Fédération Hospitalo-Universitaire de Médecine de Précision en Psychiatrie (FHU ADAPT), Fondation FondaMental, 94010, Créteil, France.
Emanuela MartinuzziInstitut de Pharmacologie Moléculaire et Cellulaire, Université Côte d'Azur, Centre National de La Recherche Scientifique, Valbonne, France.
Susanne MayerDepartment of Health Economics, Center for Public Health, Medical University of Vienna, Vienna, Austria.
Joanna MoussiopoulouDepartment of Psychiatry and Psychotherapy, University Hospital, LMU Munich, Munich, Germany.
Irina PapazovaDepartment of Psychiatry, Psychotherapy, and Psychosomatics, Medical Faculty, University of Augsburg, Bezirkskrankenhaus Augsburg, Geschwister-Schönert-Str. 1, 86156, Augsburg, Germany.
Natasa PerićDepartment of Health Economics, Center for Public Health, Medical University of Vienna, Vienna, Austria.
Elias WagnerDepartment of Psychiatry and Psychotherapy, University Hospital, LMU Munich, Munich, Germany.
Thomas Schneider-AxmannDepartment of Psychiatry and Psychotherapy, University Hospital, LMU Munich, Munich, Germany.
Judit SimonDepartment of Health Economics, Center for Public Health, Medical University of Vienna, Vienna, Austria.
Alkomiet HasanDepartment of Psychiatry, Psychotherapy, and Psychosomatics, Medical Faculty, University of Augsburg, Bezirkskrankenhaus Augsburg, Geschwister-Schönert-Str. 1, 86156, Augsburg, Germany. alkomiet.hasan@med.uni-augsburg.de.
Institut de Pharmacologie Moléculaire et Cellulaire · FRUniversity of Augsburg · DEBezirkskrankenhaus Augsburg · DELudwig-Maximilians-Universität München · DEMedical University of Vienna · ATLMU Klinikum · DECopenhagen University Hospital · DKInstitut Mondor de Recherche Biomédicale · FRTechnical University of Munich · DEUniversity of Oxford · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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.

Indexed as

Antipsychotic AgentsSchizophreniaCelecoxibClinical Trials, Phase III as TopicCytokinesDouble-Blind MethodHumansMulticenter Studies as TopicRandomized Controlled Trials as TopicTreatment OutcomeAntipsychotic AgentsCelecoxibCytokinesCelecoxibInflammationPrecision medicinePrecision psychiatrySchizophreniaTargeted therapy

Identifiers

PMID36401749
PMCPMC10374797
OpenAlexW4309408474

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.