Evidence map›Paper›PMID 38931893›Full record

ArticlePharmaceutics2024

Serum Concentration-Dose Relationship and Modulation Factors in Children and Adolescents Treated with Fluvoxamine.

Regina Taurines, Gesa Kunkel, Stefanie Fekete, Jörg M Fegert, Christoph Wewetzer, Christoph U Correll, Kristian Holtkamp, Isabel Böge, Tobias Johann Renner, Hartmut Imgart and 5 more

Abstract read
In one paragraph

Article in Pharmaceutics, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
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

3 citing papers in PubMed.

  1. Article
  2. Article
  3. Article
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

15 authors.

Regina TaurinesDepartment of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, Centre for Mental Health, University Hospital of Wuerzburg, 97080 Wuerzburg, Germany.ORCID 0000-0002-8704-1424
Gesa KunkelDepartment of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, Centre for Mental Health, University Hospital of Wuerzburg, 97080 Wuerzburg, Germany.
Stefanie FeketeDepartment of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, Centre for Mental Health, University Hospital of Wuerzburg, 97080 Wuerzburg, Germany.ORCID 0000-0003-1925-6228
Jörg M FegertDepartment of Child and Adolescent Psychiatry and Psychotherapy, University Hospital of Ulm, 89075 Ulm, Germany.
Christoph WewetzerClinics of the City Cologne GmbH, Clinic for Child and Adolescent Psychiatry and Psychotherapy, 51109 Cologne, Germany.
Christoph U CorrellDepartment of Child and Adolescent Psychiatry, Charité Universitätsmedizin Berlin, 13353 Berlin, Germany.ORCID 0000-0002-7254-5646
Kristian HoltkampDRK Fachklinik Bad Neuenahr, 53474 Bad Neuenahr-Ahrweiler, Germany.
Isabel BögeDepartment of Child and Adolescent Psychiatry and Psychotherapeutic Medicine, Medical University of Graz, 8036 Graz, Austria.
Tobias Johann RennerDepartment of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, University Hospital of Psychiatry and Psychotherapy Tuebingen, Center of Mental Health, 72076 Tuebingen, Germany.
Hartmut ImgartParkland-Clinic, Clinic for Psychosomatics and Psychotherapy, Academic Teaching Hospital for the University Gießen, 34537 Bad Wildungen, Germany.
Maike Scherf-ClavelDepartment of Psychiatry, Psychosomatics and Psychotherapy, Center of Mental Health, University Hospital Wuerzburg, 97080 Wuerzburg, Germany.ORCID 0000-0002-4780-612X
Peter HeuschmannClinical Trial Center Wuerzburg, University Hospital Wuerzburg, 97080 Wuerzburg, Germany.
Manfred GerlachDepartment of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, Centre for Mental Health, University Hospital of Wuerzburg, 97080 Wuerzburg, Germany.
Marcel RomanosDepartment of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, Centre for Mental Health, University Hospital of Wuerzburg, 97080 Wuerzburg, Germany.
Karin EgbertsDepartment of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, Centre for Mental Health, University Hospital of Wuerzburg, 97080 Wuerzburg, Germany.ORCID 0000-0002-0270-0954

Funding

Federal Institute for Drugs and Medical Devices 73.05/3832-397285/12Federal Ministry of Education and Research 01EZ0937
6 · The paper itself

Abstract

introductionFluvoxamine is used in children and adolescents ('youths') for treating obsessive compulsive disorder (OCD) but also off-label for depressive and anxiety disorders. This study aimed to investigate the relationship between fluvoxamine dose and serum concentrations, independent correlates of fluvoxamine concentrations, and a preliminary therapeutic reference range (TRR) for youths with OCD and treatment response.

methodsMulticenter naturalistic data of a therapeutic drug monitoring service, as well as prospective data of the 'TDM Vigil study' (EudraCT 2013-004881-33), were analyzed. Patient and treatment characteristics were assessed by standardized measures, including Clinical Global Impressions-Severity (CGI-S) and -Change (CGI-I), with CGI-I of much or very much improved defining treatment response and adverse drug reactions using the Udvalg for Kliniske Undersogelser (UKU) Side Effect Rating Scale. Multivariable regression analysis was used to evaluate the influence of sex, age, body weight, body mass index (BMI), and fluvoxamine dose on fluvoxamine serum concentrations.

resultsThe study included 70 youths (age = 6.7-19.6 years, OCD = 78%, mean fluvoxamine dose = 140.4 (range = 25-300) mg/d). A weak positive correlation between daily dose and steady-state trough serum concentrations was found (r DISCUSSION: These preliminary data contribute to the definition of a TRR in youth with OCD treated with fluvoxamine and identify higher BMI as a moderator of lower fluvoxamine concentrations.

Indexed as

childrenfluvoxamineobsessive compulsive disorderpharmacovigilanceserum concentrationtherapeutic drug monitoring

Identifiers

PMID38931893
PMCPMC11207785

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Registered trials

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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.