85 results on '"Taurines, R."'
Search Results
2. Development of the first consensus guidelines for therapeutic drug monitoring in Neuropsychopharmacology for children and adolescents
- Author
-
Egberts, K., additional, Fekete, S., additional, Taurines, R., additional, Gerlach, M., additional, and Romanos, M., additional
- Published
- 2024
- Full Text
- View/download PDF
3. Venlafaxine serum concentrations in children and adolescents – preliminary results of a multicenter Therapeutic Drug Monitoring trial
- Author
-
Ortmann, C., additional, Fekete, S., additional, Taurines, R., additional, Gerlach, M., additional, Romanos, M., additional, and Egberts, K., additional
- Published
- 2024
- Full Text
- View/download PDF
4. Fluvoxamine serum concentrations in children and adolescents – preliminary results of a multicenter Therapeutic Drug Monitoring (TDM) trial
- Author
-
Taurines, R., additional, Kunkel, G., additional, Fekete, S., additional, Gerlach, M., additional, Romanos, M., additional, and Egberts, K., additional
- Published
- 2024
- Full Text
- View/download PDF
5. Haloperidole serum concentrations in daily child and adolescent psychiatric practice
- Author
-
Jung, A., additional, Fekete, S., additional, Taurines, R., additional, and Egberts, K., additional
- Published
- 2024
- Full Text
- View/download PDF
6. Therapeutic drug monitoring in children and adolescents using quetiapine for the treatment of schizophrenia and other psychotic disorders – results of a pharmacovigilance study
- Author
-
Kaiser, A., additional, Egberts, K., additional, Clement, H.W., additional, Schneider-Momm, K., additional, Taurines, R., additional, Fekete, S., additional, Romanos, M., additional, and Fleischhaker, C., additional
- Published
- 2024
- Full Text
- View/download PDF
7. Tief greifende Entwicklungsstörungen
- Author
-
Warnke, A., Taurines, R., Möller, H.-J., editor, Laux, G., editor, and Kapfhammer, H.-P., editor
- Published
- 2011
- Full Text
- View/download PDF
8. Depression
- Author
-
Taurines, R., Wewetzer, Ch., Gerlach, Manfred, editor, Warnke, Andreas, editor, Mehler-Wex, Claudia, editor, Walitza, Susanne, editor, and Wewetzer, Christoph, editor
- Published
- 2009
- Full Text
- View/download PDF
9. Antidepressiva
- Author
-
Taurines, R., Wewetzer, C., Warnke, A., Gerlach, M., Gerlach, Manfred, editor, Warnke, Andreas, editor, Mehler-Wex, Claudia, editor, Walitza, Susanne, editor, and Wewetzer, Christoph, editor
- Published
- 2009
- Full Text
- View/download PDF
10. Serious adverse drug reactions to antipsychotics in children and adolescents with multiple disabilities: Avoidability and potential cost savings by Therapeutic Drug Monitoring
- Author
-
Fekete, S., additional, Güntzel, T., additional, Egberts, K., additional, Geissler, J., additional, Neubert, A., additional, Gerlach, M., additional, Romanos, M., additional, and Taurines, R., additional
- Published
- 2022
- Full Text
- View/download PDF
11. Therapeutic drug monitoring of sertraline in pediatric population: A naturalistic study with insights into the clinical response of obsessive-compulsive disorder
- Author
-
Tini, E., additional, Smigielski, L., additional, Romanos, M., additional, Wewetzer, C., additional, Karwautz, A., additional, Reitzle, K., additional, Correll, C.U., additional, Plener, P.L., additional, Malzahn, U., additional, Heuschmann, P., additional, Unterecker, S., additional, Scherf-Clavel, M., additional, Rock, H., additional, Antony, G., additional, Briegel, W., additional, Fleischhaker, C., additional, Banaschewski, T., additional, Hellenschmidt, T., additional, Imgart, H., additional, Kaess, M., additional, Kölch, M., additional, Renner, T., additional, Reuter-Dang, S.Y., additional, Rexroth, C., additional, Schulte-Körne, G., additional, Theisen, F., additional, Fekete, S., additional, Taurines, R., additional, Gerlach, M., additional, Egberts, K.M., additional, and Walitza, S., additional
- Published
- 2022
- Full Text
- View/download PDF
12. Using real patients in e-learning: case-based online training in child and adolescent psychiatry
- Author
-
Taurines, R, Radtke, F, Romanos, M, and König, S
- Subjects
E-Learning ,ddc: 610 ,child and adolescent psychiatry ,pandemic ,Pandemie ,case-based online training ,Fallbasiertes Online-Training ,Kinder- und Jugendpsychiatrie - Abstract
Objectives: In undergraduate medical education and in the subject of child and adolescent psychiatry, examining young patients face-to-face is a key element of teaching. With the abrupt shutdown of face-to-face teaching caused by the SARS-CoV-2 pandemic, a case-based online training program integrating audio and video of real patients was developed.Methods: The blended learning platform CaseTrain guides medical students in their final year through real child-psychiatric patient cases, such as anorexia, autism, or attention deficit disorder, through presentation of video and audio of real patients and parents. The teaching format complements lectures on child psychiatric topics, comprising asynchronous elements (self-study using the digital material) as well as synchronous elements (web-conferences with a specialist). Learning objectives for students were set to develop knowledge of the spectra of psychiatric disorders that affect children and to recognize approaches how to assess and manage common psychiatric problems of childhood and adolescence.Results: The feedback from medical students through oral and written evaluation was positive. They appreciated getting to know 'real-world patients' in times of such a pandemic, to learn explorative techniques from role models, and to be in close contact with the supervising specialist. In consequence of critical feedback on the length of some video sequences, these training units will undergo revision.Conclusions: Case-based online training may continue to be a useful option in a post-pandemic future as integral part of medical education, complementing face-to-face lectures and training in (child) psychiatry. Zielsetzungen: Im Studium der Humanmedizin und besonders im Fach Kinder- und Jugendpsychiatrie ist die Untersuchung junger Patienten von Angesicht zu Angesicht ein Schlüsselelement der Lehre. Mit der abrupten Einstellung der Präsenzlehre aufgrund der SARS-CoV-2-Pandemie wurde ein fallbasiertes Online-Trainingsprogramm entwickelt, in das Audio- und Videoaufnahmen von realen Patienten integriert wurden.Methoden: Auf der Plattform CaseTrain, eingebettet in ein Blended-Learning-Konzept, bearbeiten Medizinstudierende kinderpsychiatrische Patientenfälle, beispielsweise zu den Themen Anorexie, Autismus oder Aktivitäts- und Aufmerksamkeitsstörung. Videos und Audioaufnahmen realer Patientinnen und Patienten und deren Eltern sind in die Fälle integriert. Das Online-Lehrangebot für Studierende im letzten Studienjahr vor dem Praktischen Jahr wird ergänzt durch Vorlesungen zu kinderpsychiatrischen Themen und enthält sowohl asynchrone (Selbststudium unter Verwendung des digitalen Materials) als auch synchrone Elemente (Web-Konferenzen mit einer fachärztlichen Person oder erfahrenen Psychologinnen und Psychologen). Die Lerninhalte umfassen das gesamte Spektrum psychischer Störungen im Kindes- und Jugendalter. Ferner werden Kompetenzen zu häufigen psychischen Problemen im Kindes- und Jugendalter im Hinblick auf die klinische Einordnung und zielgerichteter diagnostischer und therapeutischer Verfahren vermittelt.Ergebnisse: Das Feedback durch die Medizinstudierenden mittels mündlicher und schriftlicher Evaluationen war positiv. Sie schätzten es, in Pandemie-Zeiten den "Patienten aus der realen Welt" virtuell zu begegnen, Gesprächsmethoden am Vorbild zu erlernen und sich mit den Lehrpersonen auszutauschen. Infolge der kritischen Rückmeldung zur Länge einiger Videosequenzen werden diese Ausbildungseinheiten überarbeitet.Schlussfolgerungen: Das hier vorgestellte fallbasierte Online-Trainingsprogramm kann auch in Zukunft nach der Pandemie ein wertvolles Lehrangebot darstellen und Präsenzveranstaltungen in der (Kinder- und Jugend-)Psychiatrie - wie Vorlesungen und Praktika - im Sinne eines integrierten Ausbildungsansatzes ergänzen.
- Published
- 2020
13. Therapeutic Drug Monitoring in children and adolescents – looking 10 years back and forward
- Author
-
Egberts, K, additional, Dang, SY, additional, Plener, P, additional, Karwautz, A, additional, Taurines, R, additional, Romanos, M, additional, and Gerlach, M, additional
- Published
- 2018
- Full Text
- View/download PDF
14. Capacité à mobiliser le mécanisme de développement propre (MDP) pour la gestion de l'arbre dans le Nord et l'Extrême-Nord du Cameroun
- Author
-
Leroy, Maya, Dubois, S., Soengas, B., Taurines, R., Mercier, Catherine, AgroParisTech, Centre de recherche sur les Ions, les MAtériaux et la Photonique (CIMAP - UMR 6252), Université de Caen Normandie (UNICAEN), Normandie Université (NU)-Normandie Université (NU)-École Nationale Supérieure d'Ingénieurs de Caen (ENSICAEN), Normandie Université (NU)-Commissariat à l'énergie atomique et aux énergies alternatives (CEA)-Centre National de la Recherche Scientifique (CNRS), Laboratoire de Biométrie et Biologie Evolutive - UMR 5558 (LBBE), Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Institut National de Recherche en Informatique et en Automatique (Inria)-VetAgro Sup - Institut national d'enseignement supérieur et de recherche en alimentation, santé animale, sciences agronomiques et de l'environnement (VAS)-Centre National de la Recherche Scientifique (CNRS), ENGREF, Normandie Université (NU)-Commissariat à l'énergie atomique et aux énergies alternatives (CEA)-Centre National de la Recherche Scientifique (CNRS)-Institut de Recherche sur les Matériaux Avancés (IRMA), Normandie Université (NU)-Commissariat à l'énergie atomique et aux énergies alternatives (CEA)-Université de Rouen Normandie (UNIROUEN), Normandie Université (NU)-Institut national des sciences appliquées Rouen Normandie (INSA Rouen Normandie), Institut National des Sciences Appliquées (INSA)-Normandie Université (NU)-Institut National des Sciences Appliquées (INSA)-Centre National de la Recherche Scientifique (CNRS)-Commissariat à l'énergie atomique et aux énergies alternatives (CEA)-Université de Rouen Normandie (UNIROUEN), and Institut National des Sciences Appliquées (INSA)-Normandie Université (NU)-Institut National des Sciences Appliquées (INSA)-Centre National de la Recherche Scientifique (CNRS)
- Subjects
[SHS.SOCIO]Humanities and Social Sciences/Sociology ,[SHS.ENVIR]Humanities and Social Sciences/Environmental studies ,[SHS.GESTION]Humanities and Social Sciences/Business administration ,[SDE.ES]Environmental Sciences/Environmental and Society ,[SHS.SCIPO]Humanities and Social Sciences/Political science - Abstract
no abstract
- Published
- 2005
15. Aripiprazole induced extrapyramidal symptoms in two adolescents
- Author
-
Dang, SY, primary, Jeutter, V, additional, Gerlach, M, additional, Romanos, M, additional, Taurines, R, additional, and Egberts, K, additional
- Published
- 2014
- Full Text
- View/download PDF
16. S.08.01 Potential biomarkers and genetic findings in ADHD
- Author
-
Taurines, R., primary, Renner, T.J., additional, Schecklmann, M., additional, Grünblatt, E., additional, Walitza, S., additional, Thome, J., additional, Gerlach, M., additional, and Romanos, M., additional
- Published
- 2012
- Full Text
- View/download PDF
17. Therapeutic drug monitoring (TDM) in children and adolescents treated with aripiprazole
- Author
-
Hansen, D, primary, Taurines, R, additional, Wewetzer, C, additional, Pfuhlmann, B, additional, Plener, P, additional, Mehler-Wex, C, additional, Gerlach, M, additional, and Egberts, K, additional
- Published
- 2012
- Full Text
- View/download PDF
18. Relation between dosage, serum concentration and therapeutic response of quetiapine in children and adolescents with different psychiatric disorders in clinical practice
- Author
-
Kulpok, C, primary, Taurines, R, additional, Wewetzer, C, additional, Pfuhlmann, B, additional, Plener, P, additional, Mehler-Wex, C, additional, Gerlach, M, additional, and Egberts, K, additional
- Published
- 2012
- Full Text
- View/download PDF
19. Pilot study of the application of magnetic bead protein profiling to the study of biomarkers in addiction research
- Author
-
Meister, L., primary, Alawam, K., additional, Dudley, E., additional, Taurines, R., additional, MÜller, S. E., additional, Walter, M., additional, HÖppner, J., additional, Teipel, S., additional, Donev, R. M., additional, Eckert, A., additional, Wiesbeck, G. A., additional, and Thome, J., additional
- Published
- 2011
- Full Text
- View/download PDF
20. Serum Concentrations, Therapeutic Response and Side Effects in Children and Adolescents with Impulsive-Aggressive Symptoms during Risperidone Therapy
- Author
-
Klampfl, K., primary, Taurines, R., additional, Preuss, A., additional, Burger, R., additional, Rothenhöfer, S., additional, Wewetzer, Ch., additional, Pfuhlmann, B., additional, Fegert, J., additional, Gerlach, M., additional, and Mehler-Wex, C., additional
- Published
- 2009
- Full Text
- View/download PDF
21. Therapeutic Drug Monitoring of Children and Adolescents Treated with Fluoxetine.
- Author
-
Koelch, M., Pfalzer, A.-K., Kliegl, K., Fegert, J. M., Ludolph, A. G., Rothenhöfer, S., Burger, R., Mehler-Wex, C., Taurines, R., Egberts, K., Gerlach, M., and Stingl, J.
- Subjects
FLUOXETINE ,DEPRESSION in children ,ADOLESCENT health ,SERUM ,PROPYLAMINE - Abstract
Introduction: Information about therapeutic serum levels of fluoxetine (FLX) and its major metabolite norfl uoxetine (NORFLX) in children and adolescents is scarce. Methods: Therapeutic drug monitoring (TDM) of FLX was routinely performed in 71 subjects treated for a major depressive disorder (MDD) (10-60 mg/d FLX, median: 20 mg/d). Correlations between serum concentration and dosage, age, gender, smoking habits and adverse events were analysed. Results: Serum concentrations of the active moiety (FLX + NORFLX) ranged from 21 to 613 ng/mL (mean concentration of 213 ± 118 ng/mL, median: 185 ng/mL). High inter-individual variability in serum concentrations of the active moiety of FLX at each dosage level was observed and no relationship between serum concentration and clinical outcome was found. Apart from smoking, none of the factors tested had a significant effect on the serum concentration. Discussion: It was shown that serum concentrations of the active moiety of FLX in children and adolescents seem to be similar to those in adults, with a high level of inter-individual variation. The proportion of patients who showed benefits from treatment with a dose of 20 mg/d FLX was high. [ABSTRACT FROM AUTHOR]
- Published
- 2012
- Full Text
- View/download PDF
22. Altered mRNA expression of monoaminergic candidate genes in the blood of children with attention deficit hyperactivity disorder and autism spectrum disorder
- Author
-
Manfred Gerlach, Martin Schecklmann, Regina Taurines, Christina Schwenck, Edna Grünblatt, Tobias J. Renner, Marcel Romanos, Laura Albantakis, Susanne Walitza, Johannes Thome, Lennart Reefschläger, University of Zurich, and Taurines, R
- Subjects
Oncology ,Genetic Markers ,Male ,medicine.medical_specialty ,Candidate gene ,Adolescent ,Gene Expression ,610 Medicine & health ,Comorbidity ,behavioral disciplines and activities ,2738 Psychiatry and Mental Health ,Reference Values ,Internal medicine ,mental disorders ,Monoaminergic ,medicine ,Dopamine receptor D4 ,Attention deficit hyperactivity disorder ,Humans ,Receptors, Dopamine D5 ,RNA, Messenger ,Child ,Biological Psychiatry ,Genetic Association Studies ,Whole blood ,biology ,Receptors, Dopamine D4 ,10058 Department of Child and Adolescent Psychiatry ,medicine.disease ,Psychiatry and Mental health ,Autism spectrum disorder ,Attention Deficit Disorder with Hyperactivity ,Child Development Disorders, Pervasive ,biology.protein ,Autism ,Female ,Psychology ,2803 Biological Psychiatry ,Clinical psychology - Abstract
In absence of objective clinical characteristics the identification of peripheral biomarkers in neuropsychiatric disorders is highly relevant for the diagnostic process and an individualized therapy. We analyzed mRNA-expression of monoaminergic candidate genes (DRD4, DRD5, TPH1) in peripheral tissue of patients with attention deficit hyperactivity disorder (ADHD) and autism spectrum disorders (ASD), highly comorbid with ADHD, searching for possible molecular markers for these disorders.mRNA was obtained from children and adolescents with ADHD (n = 51) and ASD (n = 26), diagnosed according to ICD-10 criteria, as well as healthy controls (n = 39). mRNA expression was determined via quantitative realtime PCR (qRT-PCR) from whole blood cells.The concentrations of DRD4-mRNA in the whole blood were significantly lower in ADHD and ASD children (19 of 26 comorbid with ADHD) compared to healthy controls. ASD patients revealed a significantly decreased DRD5 mRNA expression in comparison to the two other groups.Alterations in mRNA expression patterns provide further evidence for a relevant effect of the respective candidate genes in the pathophysiology of ADHD. Given their potential as biomarkers mRNA expression patterns may be useful tools in (differential-) diagnostic procedures of ADHD and ASD. Future studies may determine the sensitivity and specificity of these putative biomarkers in larger samples including further neuropsychiatric diagnoses.
- Published
- 2011
23. SARS-CoV-2 antigen rapid detection tests: test performance during the COVID-19 pandemic and the impact of COVID-19 vaccination.
- Author
-
Wagenhäuser I, Knies K, Pscheidl T, Eisenmann M, Flemming S, Petri N, McDonogh M, Scherzad A, Zeller D, Gesierich A, Seitz AK, Taurines R, Ernestus RI, Forster J, Weismann D, Weißbrich B, Liese J, Härtel C, Kurzai O, Dölken L, Gabel A, and Krone M
- Abstract
Background: SARS-CoV-2 antigen rapid detection tests (RDTs) emerged as point-of-care diagnostics alongside reverse transcription polymerase chain reaction (RT-qPCR) as reference., Methods: In a prospective performance assessment from 12 November 2020 to 30 June 2023 at a single centre tertiary care hospital, the sensitivity and specificity (primary endpoints) of RDTs from three manufacturers (NADAL®, Panbio™, MEDsan®) were compared to RT-qPCR as reference standard among patients, accompanying persons and staff aged ≥ six month in large-scale, clinical screening use. Regression models were used to assess influencing factors on RDT performance (secondary endpoints)., Findings: Among 78,798 paired RDT/RT-qPCR results analysed, overall RDT sensitivity was 34.5% (695/2016; 95% CI 32.4-36.6%), specificity 99.6% (76,503/76,782; 95% CI 99.6-99.7%). Over the pandemic course, sensitivity decreased in line with a lower rate of individuals showing typical COVID-19 symptoms. The lasso regression model showed that a higher viral load and typical COVID-19 symptoms were directly significantly correlated with the likelihood of a positive RDT result in SARS-CoV-2 infection, whereas age, sex, vaccination status, and the Omicron VOC were not., Interpretation: The decline in RDT sensitivity throughout the pandemic can primarily be attributed to the reduced prevalence of symptomatic infections among vaccinated individuals and individuals infected with Omicron VOC. RDTs remain valuable for detecting SARS-CoV-2 in symptomatic individuals and offer potential for detecting other respiratory pathogens in the post-pandemic era, underscoring their importance in infection control efforts., Funding: German Federal Ministry of Education and Research (BMBF), Free State of Bavaria, Bavarian State Ministry of Health and Care., Competing Interests: Declaration of interests Daniel Zeller receives honoraria from Angelini Pharma and Novartis outside of the submitted work. Manuel Krone receives honoraria from Abbott, GSK, Pfizer, and Sanofi outside of the submitted work. None of the other authors have any conflicts of interest to declare., (Copyright © 2024 The Author(s). Published by Elsevier B.V. All rights reserved.)
- Published
- 2024
- Full Text
- View/download PDF
24. ProVIA-Kids - outcomes of an uncontrolled study on smartphone-based behaviour analysis for challenging behaviour in children with intellectual and developmental disabilities or autism spectrum disorder.
- Author
-
Meerson R, Buchholz H, Kammerer K, Göster M, Schobel J, Ratz C, Pryss R, Taurines R, Romanos M, Gamer M, and Geissler J
- Abstract
Introduction: Challenging behaviour (CB) is a common issue among children with autism spectrum disorder or intellectual and developmental disability. Mental health applications are low-threshold cost-effective tools to address the lack of resources for caregivers. This pre-post study evaluated the feasibility and preliminary effectiveness of the smartphone app ProVIA-Kids using algorithm-based behaviour analysis to identify causes of CB and provide individualized practical guidance to manage and prevent CB., Methods: A total of 18 caregivers ( M = 38.9 ± 5.0) of children with a diagnosis of autism spectrum disorder (44%), intellectual and developmental disabilities (33%) or both (22%) aged 4-11 years ( M = 7.6 ± 1.8) were included. Assessments were performed before and after an 8-week intervention period. The primary outcome was the change in parental stress. Caregiver stress experience due to CB was also rated daily via ecological momentary assessments within the app. Secondary outcomes included the intensity of the child's CB, dysfunctional parenting, feelings of parental competency as well as caregivers' mood (rated daily in the app) and feedback on the app collected via the Mobile Application Rating Scale., Results: We observed increases in parental stress in terms of conscious feelings of incompetence. However, we also saw improvements in parental stress experience due to CB and overreactive parenting, and descriptive improvements in CB intensity and caregiver mood., Discussion: ProVIA-Kids pioneers behaviour analysis in a digital and automated format, with participants reporting high acceptance. Pilot results highlight the potential of the ProVIA-Kids app to positively influence child behaviour and caregiver mental health over a longer intervention period., Registration: The study was registered at https://www.drks.de (ID = DRKS00029039) on May 31, 2022., Competing Interests: RP is a partner in Lenox UG, which has set itself the goal of translating scientific findings into digital health applications. Lenox UG holds shares in Health Study Club GmbH. RP received consulting fees, reimbursements for congress attendance and travel expenses as well as payments for lectures in the context of diabetes topics and in connection with mobile health and e–mental health topics. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. The author(s) declared that they were an editorial board member of Frontiers, at the time of submission. This had no impact on the peer review process and the final decision., (© 2024 Meerson, Buchholz, Kammerer, Göster, Schobel, Ratz, Pryss, Taurines, Romanos, Gamer and Geissler.)
- Published
- 2024
- Full Text
- View/download PDF
25. Serum Concentration-Dose Relationship and Modulation Factors in Children and Adolescents Treated with Fluvoxamine.
- Author
-
Taurines R, Kunkel G, Fekete S, Fegert JM, Wewetzer C, Correll CU, Holtkamp K, Böge I, Renner TJ, Imgart H, Scherf-Clavel M, Heuschmann P, Gerlach M, Romanos M, and Egberts K
- Abstract
Introduction: Fluvoxamine 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., Methods: Multicenter 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., Results: The 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
s = 0.34, p = 0.004), with dose variation explaining 16.2% of serum concentration variability. Multivariable correlates explaining 25.3% of the variance of fluvoxamine concentrations included higher fluvoxamine dose and lower BMI. Considering responders with OCD, the estimated TRR for youths was 55-371 ng/mL, exceeding the TRR for adults with depression of 60-230 ng/mL., 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.- Published
- 2024
- Full Text
- View/download PDF
26. [Legal, clinical and structural aspects of modern intensive care for children and adolescents with mental disorders].
- Author
-
Vloet TD, Geißler J, Taurines R, Jans T, Bürger A, and Romanos M
- Subjects
- Child, Humans, Adolescent, Germany, Hospitalization, Psychotherapy, Critical Care, Mental Disorders diagnosis, Mental Disorders epidemiology, Mental Disorders therapy
- Abstract
Recent years have seen a continuous rise in the proportion of emergency contacts across all mental health-related care structures for children and adolescents. Treatment in a protective intensive care unit constitutes an essential element of care and primarily serves the immediate protection of children and adolescents during mental health crises. Protective intensive care is subject to strict legal requirements. Those requirements were amended in 2017 via changes to § 1631b BGB (German Civil Code), leading to a clear separation of the stay in protective intensive care per se and the use of coercive measures. Using the restructuring of the intensive care unit of the Clinic for Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy at the University Hospital Würzburg as an example, the article illustrates the requirements for modern acute care of children and adolescents with mental disorders.Following the modernisation at the university hospital Würzburg we could drastically reduce the duration of stays in the intensive care unit to a mean of 1.5 days across around 500 admissions per year. Consequently, the risk of hospitalism especially for patients with chronic suicidality is practically non-existent anymore. Since 2017, our cooperation with other clinics in the region has made it possible to care for all underage patients requiring treatment in a protective intensive care unit in child and adolescent psychiatric settings. Long-term treatment over many months in a protective intensive care unit no longer occurs in cases of chronic suicidality., (© 2024. The Author(s).)
- Published
- 2024
- Full Text
- View/download PDF
27. The Sensitivity of Rapid Tests for SARS-CoV-2 Antigen.
- Author
-
Knies K, Wagenhäuser I, Hofmann D, Rauschenberger V, Eisenmann M, Reusch J, Flemming S, Andres O, Petri N, Topp MS, Papsdorf M, McDonogh M, Verma-Führing R, Scherzad A, Zeller D, Böhm H, Gesierich A, Seitz AK, Kiderlen M, Gawlik M, Taurines R, Wurmb T, Ernestus RI, Forster J, Weismann D, Weißbrich B, Liese J, Vogel U, Kurzai O, Dölken L, Gabel A, and Krone M
- Subjects
- Humans, SARS-CoV-2, Sensitivity and Specificity, COVID-19
- Published
- 2023
- Full Text
- View/download PDF
28. Therapeutic Drug Monitoring in Children and Adolescents: Findings on Fluoxetine from the TDM-VIGIL Trial.
- Author
-
Frey M, Smigielski L, Tini E, Fekete S, Fleischhaker C, Wewetzer C, Karwautz A, Correll CU, Gerlach M, Taurines R, Plener PL, Malzahn U, Kornbichler S, Weninger L, Brockhaus M, Reuter-Dang SY, Reitzle K, Rock H, Imgart H, Heuschmann P, Unterecker S, Briegel W, Banaschewski T, Fegert JM, Hellenschmidt T, Kaess M, Kölch M, Renner T, Rexroth C, Walitza S, Schulte-Körne G, Romanos M, and Egberts KM
- Abstract
Fluoxetine is the recommended first-line antidepressant in many therapeutic guidelines for children and adolescents. However, little is known about the relationships between drug dose and serum level as well as the therapeutic serum reference range in this age group. Within a large naturalistic observational prospective multicenter clinical trial ("TDM-VIGIL"), a transdiagnostic sample of children and adolescents ( n = 138; mean age, 15; range, 7-18 years; 24.6% males) was treated with fluoxetine (10-40 mg/day). Analyses of both the last timepoint and all timepoints ( n = 292 observations), utilizing (multiple) linear regressions, linear mixed-effect models, and cumulative link (mixed) models, were used to test the associations between dose, serum concentration, outcome, and potential predictors. The receiver operating curve and first to third interquartile methods, respectively, were used to examine concentration cutoff and reference values for responders. A strong positive relationship was found between dose and serum concentration of fluoxetine and its metabolite. Higher body weight was associated with lower serum concentrations, and female sex was associated with lower therapeutic response. The preliminary reference ranges for the active moiety (fluoxetine+norfluoxetine) were 208-328 ng/mL (transdiagnostically) and 201.5-306 ng/mL (depression). Most patients showed marked (45.6%) or minimal (43.5%) improvements and reported no adverse effects (64.9%). This study demonstrated a clear linear dose-serum level relationship for fluoxetine in youth, with the identified reference range being within that established for adults.
- Published
- 2023
- Full Text
- View/download PDF
29. Clinical accuracy of SARS-CoV-2 rapid antigen testing in screening children and adolescents.
- Author
-
Krone M, Wagenhäuser I, Knies K, Hofmann D, Engels G, Taurines R, McDonogh M, Flemming S, Meyer T, Böhm H, Scherzad A, Eisenmann M, Rauschenberger V, Gabel A, Petri N, Reusch J, Forster J, Weißbrich B, Dölken L, Kurzai O, Vogel U, Härtel C, Liese J, and Andres O
- Subjects
- Humans, Adolescent, Child, Sensitivity and Specificity, Antigens, Viral, SARS-CoV-2, COVID-19 diagnosis
- Abstract
Competing Interests: Declaration of Competing Interest Manuel Krone receives honoraria from Abbott outside the submitted work. None of the other authors has any conflicts of interests to declare.
- Published
- 2023
- Full Text
- View/download PDF
30. Virus variant-specific clinical performance of SARS coronavirus two rapid antigen tests in point-of-care use, from November 2020 to January 2022.
- Author
-
Wagenhäuser I, Knies K, Hofmann D, Rauschenberger V, Eisenmann M, Reusch J, Gabel A, Flemming S, Andres O, Petri N, Topp MS, Papsdorf M, McDonogh M, Verma-Führing R, Scherzad A, Zeller D, Böhm H, Gesierich A, Seitz AK, Kiderlen M, Gawlik M, Taurines R, Wurmb T, Ernestus RI, Forster J, Weismann D, Weißbrich B, Dölken L, Liese J, Kaderali L, Kurzai O, Vogel U, and Krone M
- Subjects
- Humans, Prospective Studies, RNA, Viral, SARS-CoV-2 genetics, Sensitivity and Specificity, Point-of-Care Systems, COVID-19 diagnosis
- Abstract
Objectives: Antigen rapid diagnostic tests (RDTs) for SARS coronavirus 2 (SARS-CoV-2) are quick, widely available, and inexpensive. Consequently, RDTs have been established as an alternative and additional diagnostic strategy to quantitative reverse transcription polymerase chain reaction (RT-qPCR). However, reliable clinical and large-scale performance data specific to a SARS-CoV-2 virus variant of concern (VOC) are limited, especially for the Omicron VOC. The aim of this study was to compare RDT performance among different VOCs., Methods: This single-centre prospective performance assessment compared RDTs from three manufacturers (NADAL, Panbio, MEDsan) with RT-qPCR including deduced standardized viral load from oropharyngeal swabs for detection of SARS-CoV-2 in a clinical point-of-care setting from November 2020 to January 2022., Results: Among 35 479 RDT/RT-qPCR tandems taken from 26 940 individuals, 164 of the 426 SARS-CoV-2 positive samples tested true positive with an RDT corresponding to an RDT sensitivity of 38.50% (95% CI, 34.00-43.20%), with an overall specificity of 99.67% (95% CI, 99.60-99.72%). RDT sensitivity depended on viral load, with decreasing sensitivity accompanied by descending viral load. VOC-dependent sensitivity assessment showed a sensitivity of 42.86% (95% CI, 32.82-53.52%) for the wild-type SARS-CoV-2, 43.42% (95% CI, 32.86-54.61%) for the Alpha VOC, 37.67% (95% CI, 30.22-45.75%) for the Delta VOC, and 33.67% (95% CI, 25.09-43.49%) for the Omicron VOC. Sensitivity in samples with high viral loads of ≥10
6 SARS-CoV-2 RNA copies per mL was significantly lower in the Omicron VOC (50.00%; 95% CI, 36.12-63.88%) than in the wild-type SARS-CoV-2 (79.31%; 95% CI, 61.61-90.15%; p 0.015)., Discussion: RDT sensitivity for detection of the Omicron VOC is reduced in individuals infected with a high viral load, which curtails the effectiveness of RDTs. This aspect furthert: limits the use of RDTs, although RDTs are still an irreplaceable diagnostic tool for rapid, economic point-of-care and extensive SARS-CoV-2 screening., (Copyright © 2022 European Society of Clinical Microbiology and Infectious Diseases. Published by Elsevier Ltd. All rights reserved.)- Published
- 2023
- Full Text
- View/download PDF
31. Value of a web-based pediatric drug information system to prevent serious adverse drug reactions in child and adolescent psychiatry.
- Author
-
Fekete S, Kulpok C, Taurines R, Egberts K, Geissler J, Gerlach M, Malonga Makosi D, König J, Urschitz MS, Toni I, Neubert A, and Romanos M
- Subjects
- Adolescent, Humans, Child, Retrospective Studies, Psychotropic Drugs adverse effects, Information Systems, Internet, Adolescent Psychiatry, Drug-Related Side Effects and Adverse Reactions epidemiology, Drug-Related Side Effects and Adverse Reactions prevention & control
- Abstract
Psychotropic drugs are frequently prescribed 'off-label' to children and adolescents and carry the risk of serious adverse drug reactions (sADR). We examined the frequency of sADRs of psychotropic drugs in pediatric inpatients and explored their potential preventability through following the recommendations of a web-based pediatric drug information system (PDIS). The potential socio-economic impacts of using this online system is also addressed. Routine clinical data from all inpatients treated in a child and adolescent psychiatry department between January 2017 and December 2018 were retrospectively examined for the occurrence of sADRs as defined by the European Medicines Agency. The preventability of the sADRs was assessed based on the information of the PDIS. Furthermore, the expected prolongation of the hospital stay due to sADRs was calculated as well as the associated treatment costs. The study was supported by the Innovation Fund of the Joint Federal Committee, grant number 01NVF16021. In total, 1036 patients were screened of whom 658 (63.5%) received psychopharmacological treatment. In 53 (8.1%) of these patients 54 sADRs were documented, of which 37 sADRs were identified as potentially preventable through PDIS. Mitigating sADR through PDIS would likely have prevented prolonged hospital stays and conferred considerable savings for health insurance companies. PDIS provides systematic and evidence-based information about pediatric psychopharmacotherapy and helps to prevent prescribing errors. Therefore, PDIS is a useful tool to increase drug therapy safety in child and adolescent psychiatry. Further prospective studies are needed to confirm the results., (© 2022. The Author(s).)
- Published
- 2023
- Full Text
- View/download PDF
32. Serious Adverse Drug Reactions to Antipsychotics in Minors with Multiple Disabilities: Preventability and Potential Cost Savings by Therapeutic Drug Monitoring.
- Author
-
Fekete S, Güntzel T, Egberts K, Geissler J, Neubert A, Gerlach M, Romanos M, and Taurines R
- Subjects
- Child, Adolescent, Humans, Drug Monitoring, Retrospective Studies, Minors, Cost Savings, Antipsychotic Agents adverse effects, Drug-Related Side Effects and Adverse Reactions epidemiology, Drug-Related Side Effects and Adverse Reactions prevention & control, Drug-Related Side Effects and Adverse Reactions drug therapy
- Abstract
Introduction: Children and adolescents with multiple disabilities and mental disorders (CAMD) are frequently treated with antipsychotic drugs. However, CAMD are particularly susceptible to serious adverse drug reactions (sADRs). This retrospective study examined the frequency of sADRs to antipsychotics in CAMD. Further, the potential preventability of these sADRs through therapeutic drug monitoring (TDM) and the potential socio-economic benefits of TDM were explored., Methods: Routine clinical data of all patients treated at a specialized psychiatric clinic for CAMD between January 2017 and December 2018 were retrospectively examined. Data on the occurrence of sADRs (definition according to the European Medicines Agency), their causality with antipsychotics, as well as their preventability (Schumock criteria) were extracted from patient files. The prolongation of the hospital stay due to sADRs was calculated, and the cost savings were estimated if TDM had been applied. The data were based on a subsample of the KiDSafe project, supported by the Innovation Fund of the Joint Federal Committee, grant number 01NVF16021., Results: One hundred two CAMD who were administered at least one antipsychotic drug during inpatient treatment were identified. Of these patients, 22 (21.6%) sADRs with a possible causal relationship with the antipsychotic treatment were documented. Eleven sADRs (50%) could potentially have been prevented through TDM. Mitigating sADRs through TDM likely would have prevented prolonged hospital stays and thus conferred considerable savings for health insurance companies., Discussion: The routine implementation of TDM is urgently recommended for antipsychotic treatment in CAMD to increase drug therapy safety., Competing Interests: K. Egberts, M. Gerlach and M. Romanos received grant research support from the German Federal Institute for Drugs and Medical Devices (BfArM- reference number: 73.05/3832–397285/12) and are members of the ‘Competence Network on Therapeutic Drug Monitoring in Child and Adolescent Psychiatry’, which was supported by the German Federal Ministry of Education and Research (BMBF-FKZ: 01EZ0937) and the ‘Verein zur Durchführung Neurowissenschaftlicher Tagungen e.V.’, Berlin. A. Neubert received funding from the German Ministry of Health and German innovation fund of the Federal Joint Committee (G-BA). S. Fekete, R. Taurines, J. Geissler and T. Güntzel have no conflicts of interest., (The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial-License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/).)
- Published
- 2023
- Full Text
- View/download PDF
33. Smartphone-based behaviour analysis for challenging behaviour in intellectual and developmental disabilities and autism spectrum disorder - Study protocol for the ProVIA trial.
- Author
-
Geissler J, Buchholz H, Meerson R, Kammerer K, Göster M, Schobel J, Ratz C, Taurines R, Pryss R, and Romanos M
- Abstract
Background: Challenging behaviour (CB) comprises various forms of aggressive and problematic behaviours frequently occurring in children with intellectual and developmental disability (IDD) or autism spectrum disorder (ASD). CB often arises from impaired communication or problem solving skills. It is often met with coercive measure due to a lack of alternative strategies on the part of the caregiver, while it also impacts on the caregivers due to the exposure to physical harm and high levels of stress. Within the ProVIA project we developed a smartphone-based tool for caregivers of children with IDD and/or ASD to prevent and modify CB. The ProVIA app systematically helps caregivers to identify specific causes of CB and provides individualised practical guidance to prevent CB and consecutive coercive measures, thus aiming to improve the health and well-being of the children and caregivers., Methods: In this uncontrolled open trial we will enrol N = 25 caregivers of children aged 3-11 years with a diagnosis of IDD and/or ASD. Participants will use the ProVIA-Kids app for 8 weeks. During the intervention phase, participants will conduct behaviour analyses after each instance of CB. The app will summarise the identified putative causes for the CB in each situation, and provide recommendations regarding the handling and prevention of CB. Furthermore, the app will aggregate data from all available behaviour analyses and identify the most relevant (i.e., most frequently reported) risk factors. Measurement points are at baseline (T0), after the intervention (T1) and 12 weeks after the end of the intervention (follow-up; T2). The primary outcome is the absolute change in parental stress (EBI total scale) between T0 and T1. Further aspects of interest are changes in CB severity and frequency, caregiver mood, satisfaction with the parenting role (EFB-K total scale) and experienced parenting competence (FKE total scale). Pre-post comparisons will be analysed with paired sample t -tests., Discussion: ProVIA is pioneering structured behaviour analysis via smartphone, assessing predefined causes of CB and providing feedback and recommendations. If this approach proves successful, the ProVIA-Kids app will be a valuable tool for caregivers to prevent CB and improve their own as well as the children's quality of life., Trial Registration: The study is registered at https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_IDDRKS00029039 (registered May 31, 2022)., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. The handling editor was currently organizing a Research Topic with the author RP., (Copyright © 2022 Geissler, Buchholz, Meerson, Kammerer, Göster, Schobel, Ratz, Taurines, Pryss and Romanos.)
- Published
- 2022
- Full Text
- View/download PDF
34. Serious Adverse Drug Reactions in Children and Adolescents Treated On- and Off-Label with Antidepressants and Antipsychotics in Clinical Practice.
- Author
-
Egberts KM, Gerlach M, Correll CU, Plener PL, Malzahn U, Heuschmann P, Unterecker S, Scherf-Clavel M, Rock H, Antony G, Briegel W, Fleischhaker C, Häge A, Hellenschmidt T, Imgart H, Kaess M, Karwautz A, Kölch M, Reitzle K, Renner T, Reuter-Dang SY, Rexroth C, Schulte-Körne G, Theisen FM, Walitza S, Wewetzer C, Fekete S, Taurines R, and Romanos M
- Subjects
- Adolescent, Antidepressive Agents adverse effects, Child, Female, Humans, Off-Label Use, Psychotropic Drugs therapeutic use, Antipsychotic Agents adverse effects, Drug-Related Side Effects and Adverse Reactions drug therapy, Drug-Related Side Effects and Adverse Reactions epidemiology
- Abstract
Introduction: Despite the growing evidence base for psychotropic drug treatment in pediatric patients, knowledge about the benefit-risk ratio in clinical practice remains limited. The 'Therapeutic Drug Monitoring (TDM)-VIGIL' study aimed to evaluate serious adverse drug reactions (ADRs) in children and adolescents treated with antidepressants and/or antipsychotics in approved ('on-label'), and off-label use in clinical practice., Methods: Psychiatric pediatric patients aged 6-18 years treated with antidepressants and/or antipsychotics either on-label or off-label were prospectively followed between October 2014 and December 2018 within a multicenter trial. Follow-up included standardized assessments of response, serious ADRs and therapeutic drug monitoring., Results: 710 youth (age=14.6±2.2 years, female=66.6%) were observed for 5.5 months on average; 76.3% received antidepressants, 47.5% antipsychotics, and 25.2% both. Altogether, 55.2% of the treatment episodes with antidepressants and 80.7% with antipsychotics were off-label. Serious ADRs occurred in 8.3% (95%CI=6.4-10.6%) of patients, mainly being psychiatric adverse reactions (77.4%), predominantly suicidal ideation and behavior. The risk of serious ADRs was not significantly different between patients using psychotropics off-label and on-label (antidepressants: 8.1% vs. 11.3%, p=0.16; antipsychotics: 8.7% vs 7.5%, p=0.67). Serious ADRs occurred in 16.6% of patients who were suicidal at enrollment versus 5.6% of patients who were not suicidal (relative risk 3.0, 95%CI=1.9-4.9)., Conclusion: Off-label use of antidepressants and antipsychotics in youth was not a risk factor for the occurrence of serious ADRs in a closely monitored clinical setting. Results from large naturalistic trials like ours can contribute to bridging the gap between knowledge from randomized controlled trials and real-world clinical settings., Competing Interests: KE, RT, MR, MG, and PP received grant research support from BfArM. MR currently receives a research grant from Kids-Safe, Innovation Committee of the German Federal Joint Committee (G-BA grant number 01NVF16021). AH received conference support, speaker´s fees, and/or served in an advisory role for Shire/Takeda and Lilly; he was involved as an investigator in clinical trials by Shire, Takeda, Janssen-Cilag, Otsuka, Sunovion, Servier, Lundbeck, Nuvelution, Gedeon Richter, and Emalex. PH reports grants from the German Ministry of Research and Education, European Union, Berlin Chamber of Physicians, German Parkinson Society, University Hospital Wuerzburg, Robert Koch Institute, German Heart Foundation, Federal Joint Committee (G-BA) within the Innovationfond, German Research Foundation, Bavarian State (ministry for science and the arts), German Cancer Aid, grants from Charité – Universitätsmedizin Berlin (within Mondafis, Mondafis is supported by an unrestricted research grant to the Charité from Bayer), University Göttingen (within FIND-AF randomized; FIND-AF randomized is supported by an unrestricted research grant to the University Göttingen from Boehringer-Ingelheim), University Hospital Heidelberg (within RASUNOA-prime; RASUNOA-prime is supported by an unrestricted research grant to the University Hospital Heidelberg from Bayer, BMS, Boehringer-Ingelheim, Daiichi Sankyo. PP receives grant research support from the German Federal Ministry of Education and Research (BMBF) and was involved in clinical trials from Servier and Lundbeck; he received an advisor honorarium from Boehringer Ingelheim and speaker´s honoraria from Shire, Infectopharm, and Gerot Lannach. CC has been a consultant and/or advisor to or has received honoraria from AbbVie, Acadia, Alkermes, Allergan, Angelini, Aristo, Axsome, Damitsa, Gedeon Richter, Hikma, IntraCellular Therapies, Janssen/J&J, Karuna, LB Pharma, Lundbeck, MedAvante-ProPhase, MedInCell, Medscape, Merck, Mitsubishi Tanabe Pharma, Mylan, Neurocrine, Noven, Otsuka, Pfizer, Recordati, Rovi, Servier, SK Life Science, Sumitomo Dainippon, Sunovion, Supernus, Takeda, Teva, and Viatris. He provided expert testimony for Janssen and Otsuka. He served on a Data Safety Monitoring Board for Lundbeck, Rovi, Supernus, and Teva. He has received grant support from Janssen and Takeda. He received royalties from UpToDate and is also a stock option holder of LB Pharma. SW has received in the last 5 years royalties from Thieme, Hogrefe, Kohlhammer, Springer, and Beltz. Her work was supported in the last 5 years by the Swiss National Science Foundation, diff. EU FP7s programs, Hochspezialisierte Medizin of the Kanton Zurich, Switzerland, BfArM, ZInEP, Hartmann Müller Stiftung, Olga Mayenfisch, Gertrud Thalmann, Vontobel, Unicentia, Erika Schwarz Fonds, Gesundheitsförderung Schweiz. The other authors (GA, WB, SF, CF, TH, HI, UM, MKE, AK, MKO, KR, TR, HR, SR, CR, MS, GS, FT, SU, and CW) declare no (further) conflict of interest., (The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial-License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/).)
- Published
- 2022
- Full Text
- View/download PDF
35. Therapeutic drug monitoring of sertraline in children and adolescents: A naturalistic study with insights into the clinical response and treatment of obsessive-compulsive disorder.
- Author
-
Tini E, Smigielski L, Romanos M, Wewetzer C, Karwautz A, Reitzle K, Correll CU, Plener PL, Malzahn U, Heuschmann P, Unterecker S, Scherf-Clavel M, Rock H, Antony G, Briegel W, Fleischhaker C, Banaschewski T, Hellenschmidt T, Imgart H, Kaess M, Kölch M, Renner T, Reuter-Dang SY, Rexroth C, Schulte-Körne G, Theisen F, Fekete S, Taurines R, Gerlach M, Egberts KM, and Walitza S
- Subjects
- Adolescent, Child, Drug Monitoring methods, Humans, Prospective Studies, Selective Serotonin Reuptake Inhibitors therapeutic use, Obsessive-Compulsive Disorder diagnosis, Obsessive-Compulsive Disorder drug therapy, Sertraline therapeutic use
- Abstract
Background: Sertraline is a selective serotonin reuptake inhibitor with specific indications in child and adolescent psychiatry. Notwithstanding its frequent use and clinical benefits, the relationship between pharmacokinetics, pharmacodynamics, efficacy, and tolerability of sertraline across indications, particularly in non-adult patients, is not fully understood., Method: This naturalistic therapeutic drug monitoring (TDM) study was conducted in a transdiagnostic sample of children and adolescents treated with sertraline (n = 78; mean age, 14.22 ± 2.39; range, 7-18 years) within the prospective multicenter "TDM-VIGIL" project. Associations between dose, serum concentration, and medication-specific therapeutic and side effects based on the Clinical Global Impression scale were examined. Tolerability was measured qualitatively with the 56-item Pediatric Adverse Event Rating Scale., Results: A strong linear positive dose-serum concentration relationship (with dose explaining 45% of the variance in concentration) and significant effects of weight and co-medication were found. Neither dose nor serum concentration were associated with side effects. An overall mild-to-moderate tolerability profile of sertraline was observed. In contrast with the transdiagnostic analysis that did not indicate an effect of concentration, when split into depression (MDD) and obsessive-compulsive disorder (OCD) diagnoses, the probability of clinical improvement significantly increased as both dose and concentration increased for OCD, but not for MDD., Conclusions: This TDM-flexible-dose study revealed a significant diagnosis-specific effect between sertraline serum concentration and clinical efficacy for pediatric OCD. While TDM already guides clinical decision-making regarding compliance, dose calibration, and drug-drug interactions, combining TDM with other methods, such as pharmacogenetics, may facilitate a personalized medicine approach in psychiatry., (Copyright © 2022 The Authors. Published by Elsevier Inc. All rights reserved.)
- Published
- 2022
- Full Text
- View/download PDF
36. Clinical performance evaluation of SARS-CoV-2 rapid antigen testing in point of care usage in comparison to RT-qPCR.
- Author
-
Wagenhäuser I, Knies K, Rauschenberger V, Eisenmann M, McDonogh M, Petri N, Andres O, Flemming S, Gawlik M, Papsdorf M, Taurines R, Böhm H, Forster J, Weismann D, Weißbrich B, Dölken L, Liese J, Kurzai O, Vogel U, and Krone M
- Subjects
- Adult, Aged, COVID-19 immunology, COVID-19 virology, COVID-19 Nucleic Acid Testing methods, COVID-19 Nucleic Acid Testing standards, COVID-19 Serological Testing methods, Female, Humans, Male, Middle Aged, Reagent Kits, Diagnostic standards, Sensitivity and Specificity, Spike Glycoprotein, Coronavirus genetics, Spike Glycoprotein, Coronavirus immunology, Viral Load, COVID-19 diagnosis, COVID-19 Serological Testing standards, Point-of-Care Testing standards
- Abstract
Background: Antigen rapid diagnostic tests (RDT) for SARS-CoV-2 are fast, broadly available, and inexpensive. Despite this, reliable clinical performance data from large field studies is sparse., Methods: In a prospective performance evaluation study, RDT from three manufacturers (NADAL®, Panbio™, MEDsan®, conducted on different samples) were compared to quantitative reverse transcription polymerase chain reaction (RT-qPCR) in 5 068 oropharyngeal swabs for detection of SARS-CoV-2 in a hospital setting. Viral load was derived from standardised RT-qPCR Cycle threshold (C
t ) values. The data collection period ranged from November 12, 2020 to February 28, 2021., Findings: The sensitivity of RDT compared to RT-qPCR was 42·57% (95% CI 33·38%-52·31%). The specificity was 99·68% (95% CI 99·48%-99·80%). Sensitivity declined with decreasing viral load from 100% in samples with a deduced viral load of ≥108 SARS-CoV-2 RNA copies per ml to 8·82% in samples with a viral load lower than 104 SARS-CoV-2 RNA copies per ml. No significant differences in sensitivity or specificity could be observed between samples with and without spike protein variant B.1.1.7. The NPV in the study cohort was 98·84%; the PPV in persons with typical COVID-19 symptoms was 97·37%, and 28·57% in persons without or with atypical symptoms., Interpretation: RDT are a reliable method to diagnose SARS-CoV-2 infection in persons with high viral load. RDT are a valuable addition to RT-qPCR testing, as they reliably detect infectious persons with high viral loads before RT-qPCR results are available., Funding: German Federal Ministry for Education and Science (BMBF), Free State of Bavaria., Competing Interests: Declaration of Competing Interest None of the authors has any conflict of interest., (Copyright © 2021 The Authors. Published by Elsevier B.V. All rights reserved.)- Published
- 2021
- Full Text
- View/download PDF
37. [Therapeutic drug monitoring to optimize psychopharmacotherapy in children and adolescents - Update and guidelines for practice].
- Author
-
Egberts K, Fekete S, Häge A, Hiemke C, Scherf-Clavel M, Taurines R, Unterecker S, Gerlach M, and Romanos M
- Subjects
- Adolescent, Child, Humans, Psychotropic Drugs adverse effects, Drug Monitoring, Mental Disorders diagnosis, Mental Disorders drug therapy
- Abstract
Therapeutic drug monitoring to optimize psychopharmacotherapy in children and adolescents - Update and guidelines for practice Abstract. Despite the improved evidence base, many uncertainties remain in child and adolescent psychiatric pharmacotherapy about the efficacy and tolerability of drugs, which are often prescribed off-label or in combination therapy in this age group. Because medium- to long-term use is unavoidable in many cases, clinicians should minimize adverse drug reactions as far as possible and tailor an effective dosage to the individual characteristics of the patient. Not only are children and adolescents particularly vulnerable to certain adverse drug effects, they are also exposed to iatrogenic risks from dosing or application errors, which can lead to under- or overdosing with correspondingly negative effects on the success of the therapy. In addition to determining a strict indication, it is therefore essential to establish precise dosage and systematic monitoring of the safety of the psychopharmacotherapy. This article introduces therapeutic drug monitoring as a useful clinical tool and describes how its correct application in practice can improve the efficacy as well as the safety and tolerability of psychotropic therapy in children and adolescents for the immediate benefit of patients. Keywords: Psychopharmacotherapy, adverse drug reactions, pharmacovigilance, therapeutic drug monitoring, quality assurance.
- Published
- 2021
- Full Text
- View/download PDF
38. Altered urinary tetrahydroisoquinoline derivatives in patients with Tourette syndrome: reflection of dopaminergic hyperactivity?
- Author
-
Capetian P, Roessner V, Korte C, Walitza S, Riederer F, Taurines R, Gerlach M, and Moser A
- Subjects
- Humans, Attention Deficit Disorder with Hyperactivity, Tetrahydroisoquinolines, Tic Disorders, Tourette Syndrome
- Abstract
Tetrahydroisoquinolines (TIQs) such as salsolinol (SAL), norsalsolinol (NSAL) and their methylated derivatives N-methyl-norsalsolinol (NMNSAL) and N-methyl-salsolinol (NMSAL), modulate dopaminergic neurotransmission and metabolism in the central nervous system. Dopaminergic neurotransmission is thought to play an important role in the pathophysiology of chronic tic disorders, such as Tourette syndrome (TS). Therefore, the urinary concentrations of these TIQ derivatives were measured in patients with TS and patients with comorbid attention-deficit/hyperactivity disorder (TS + ADHD) compared with controls. Seventeen patients with TS, 12 with TS and ADHD, and 19 age-matched healthy controls with no medication took part in this study. Free levels of NSAL, NMNSAL, SAL, and NMSAL in urine were measured by a two-phase chromatographic approach. Furthermore, individual TIQ concentrations in TS patients were used in receiver-operating characteristics (ROC) curve analysis to examine the diagnostic value. NSAL concentrations were elevated significantly in TS [434.67 ± 55.4 nmol/l (standard error of mean = S.E.M.), two-way ANOVA, p < 0.0001] and TS + ADHD patients [605.18 ± 170.21 nmol/l (S.E.M.), two-way ANOVA, p < 0.0001] compared with controls [107.02 ± 33.18 nmol/l (S.E.M.), two-way ANOVA, p < 0.0001] and NSAL levels in TS + ADHD patients were elevated significantly in comparison with TS patients (two-way ANOVA, p = 0.017). NSAL demonstrated an AUC of 0.93 ± 0.046 (S.E.M) the highest diagnostic value of all metabolites for the diagnosis of TS. Our results suggest a dopaminergic hyperactivity underlying the pathophysiology of TS and ADHD. In addition, NSAL concentrations in urine may be a potential diagnostic biomarker of TS.
- Published
- 2021
- Full Text
- View/download PDF
39. Therapeutic drug monitoring of children and adolescents treated with aripiprazole: observational results from routine patient care.
- Author
-
Egberts K, Reuter-Dang SY, Fekete S, Kulpok C, Mehler-Wex C, Wewetzer C, Karwautz A, Mitterer M, Holtkamp K, Boege I, Burger R, Romanos M, Gerlach M, and Taurines R
- Subjects
- Adolescent, Adult, Aripiprazole, Child, Drug Monitoring, Female, Humans, Male, Patient Care, Antipsychotic Agents therapeutic use, Schizophrenia drug therapy
- Abstract
Although aripiprazole is one of the most used antipsychotics, knowledge about serum concentrations in children and adolescents is scarce and age-specific therapeutic ranges have not been established yet. Data of a routine therapeutic drug monitoring service were analyzed in order to evaluate the relationship between dose and serum concentration of aripiprazole in children and adolescents. The study also aimed to evaluate whether the therapeutic reference range defined for adults with schizophrenia (100-350 ng/ml) is applicable for minors. Data from 130 patients (aged 7-19 years) treated with aripiprazole for different indications in doses of 2-30 mg/day were evaluated. Patient characteristics, doses, serum concentrations and therapeutic outcome were assessed by standardized measures. A positive mean correlation between body weight-corrected daily dose and aripiprazole concentration was found (r
p = 0.59, p < 0.001) with variation in dose explaining 35% of the variability in serum concentrations. Girls had on average 41% higher dose-corrected concentrations than boys (244.9 versus 173.4 mg/l; p = 0.006). Aripiprazole concentrations did not vary with co-medication (p = 0.22). About 70% of all measured serum concentrations were within the recommended therapeutic range for adults. Using a calculation method in all responding patients with an ICD-10 F2 diagnosis for a rough estimation of a preliminary therapeutic window also demonstrated a similar therapeutic range of aripiprazole in minors (105.9-375.3 ng/ml) than for adults. If confirmed in larger samples and more controlled study designs, these data may contribute to the definition of a therapeutic range of aripiprazole concentrations in children and adolescents.- Published
- 2020
- Full Text
- View/download PDF
40. Study protocol of the multi-centre, randomised controlled trial of the Frankfurt Early Intervention Programme A-FFIP versus early intervention as usual for toddlers and preschool children with Autism Spectrum Disorder (A-FFIP study).
- Author
-
Kitzerow J, Hackbusch M, Jensen K, Kieser M, Noterdaeme M, Fröhlich U, Taurines R, Geißler J, Wolff N, Roessner V, Bast N, Teufel K, Kim Z, and Freitag CM
- Subjects
- Child, Preschool, Humans, Parents psychology, Prospective Studies, Quality of Life, Randomized Controlled Trials as Topic methods, Multicenter Studies as Topic, Clinical Trials, Phase III as Topic, Autism Spectrum Disorder psychology, Autism Spectrum Disorder therapy
- Abstract
Background: Naturalistic developmental behavioural interventions (NDBI) have been shown to improve autism-specific symptoms in young children with Autism Spectrum Disorder (ASD). NDBI approaches, such as the ASD-specific Frankfurt Early Intervention Programme for ASD (A-FFIP), are based on ASD-specific developmental and learning aspects. A-FFIP is a low-intensity intervention which can easily be implemented in the local health care/social welfare system. The aim of the present study is to establish 1-year efficacy of the manualised early intervention programme A-FFIP in toddlers and preschool children with ASD. It is hypothesised that A-FFIP will result in improved ASD-specific symptoms compared to early intervention as usual (EIAU). Child- and family-specific secondary outcomes, as well as moderators and mediators of outcome, will be explored., Methods/design: A prospective, multi-centre, parallel-group, randomised controlled, phase-III trial comparing A-FFIP versus EIAU. A total of 134 children (A-FFIP: 67, EIAU: 67) aged 24-66 months at baseline assessment meeting the criteria for ASD (DSM-5) will be included. The primary outcome is the absolute change of the total score of the Brief Observation of Social Communication Change (BOSCC-AT) between baseline (T2) and 1-year follow-up (T6). The treatment effect will be tested, adjusted for relevant covariates applying a mixed model for repeated measures. Secondary outcomes are BOSCC social communication and repetitive-behaviour scores, single ASD symptoms, language, cognition, psychopathology, parental well-being and family quality of life. Predictors, moderators and mediating mechanisms will be explored., Discussion: If efficacy of the manualised A-FFIP early intervention is established, the current study has the potential to change clinical practice strongly towards the implementation of a low-intensity, evidence-based, natural early intervention in ASD. Early intervention in ASD requires specialist training, which subsequently needs to be developed or included into current training curricula., Trial Registration: German Registry for Clinical Trials (Deutscher Register Klinischer Studien, DRKS); ID: 00016330. Retrospectively registered on 4 January 2019. URL: https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00016330.
- Published
- 2020
- Full Text
- View/download PDF
41. High-resolution chromosomal microarray analysis for copy-number variations in high-functioning autism reveals large aberration typical for intellectual disability.
- Author
-
Werling AM, Grünblatt E, Oneda B, Bobrowski E, Gundelfinger R, Taurines R, Romanos M, Rauch A, and Walitza S
- Subjects
- Adolescent, Child, Child, Preschool, Female, Humans, Male, Microarray Analysis, Autism Spectrum Disorder genetics, DNA Copy Number Variations genetics, Intellectual Disability genetics
- Abstract
Copy-number variants (CNVs), in particular rare, small and large ones (< 1% frequency) and those encompassing brain-related genes, have been shown to be associated with neurodevelopmental disorders like autism spectrum disorders (ASDs), attention deficit hyperactivity disorder (ADHD), and intellectual disability (ID). However, the vast majority of CNV findings lack specificity with respect to autistic or developmental-delay phenotypes. Therefore, the aim of the study was to investigate the size and frequency of CNVs in high-functioning ASD (HFA) without ID compared with a random population sample and with published findings in ASD and ID. To investigate the role of CNVs for the "core symptoms" of high-functioning autism, we included in the present exploratory study only patients with HFA without ID. The aim was to test whether HFA have similar large rare (> 1 Mb) CNVs as reported in ASD and ID. We performed high-resolution chromosomal microarray analysis in 108 children and adolescents with HFA without ID. There was no significant difference in the overall number of rare CNVs compared to 124 random population samples. However, patients with HFA carried significantly more frequently CNVs containing brain-related genes. Surprisingly, six HFA patients carried very large CNVs known to be typically present in ID. Our findings provide new evidence that not only small, but also large CNVs affecting several key genes contribute to the genetic etiology/risk of HFA without affecting their intellectual ability.
- Published
- 2020
- Full Text
- View/download PDF
42. [Polypharmacy of psychotropic drugs in child and adolescent psychiatry in Germany - rather the rule than the exception].
- Author
-
Vloet TD, Egberts K, Taurines R, Wewetzer C, Mehler-Wex C, Plener PL, Romanos M, and Gerlach M
- Subjects
- Adolescent, Antidepressive Agents adverse effects, Child, Germany, Humans, Psychotropic Drugs adverse effects, Adolescent Psychiatry, Antidepressive Agents administration & dosage, Child Psychiatry, Polypharmacy, Psychotropic Drugs administration & dosage
- Abstract
Polypharmacy of psychotropic drugs in child and adolescent psychiatry in Germany - rather the rule than the exception Abstract. Background: Polypharmacy increases the risk of interactions and enhances the chance of adverse drug reactions (ADRs). Hence, child and adolescent psychiatrists generally try to avoid polypharmacy with psychotropic drugs. However, only little data regarding the frequency of polypharmacy in child and adolescent psychiatry are available. This study analyzes clinical data on polypharmacy and the possible association with a higher risk of ADRs in Germany, with a focus on antidepressants and antipsychotics. Methods: We investigated a total of 940 datasets from descriptive studies on therapeutic drug monitoring (TDM) of pediatric patients treated with different psychotropic drugs. Results: The frequency of polypharmacy ranged up to 45.6 % (escitalopram) and 72.1 % (olanzapine). In 17.4 % of the cases, polypharmacy consisted of four or more psycho-/neuropharmacological substances. No increased incidence of ADRs was reported with polypharmacy of antipsychotics compared to monotherapy. Polypharmacy with sertraline was associated with a higher number of ADRs. Discussion and Conclusion: There is a high prevalence of polypharmacy with psychotropic drugs in child and adolescent psychiatry in Germany. Conclusions concerning individual drugs should be drawn with care since the subsample sizes were relatively small. However, our results do provide an indication of the prevalence of polypharmacy, although the validity of the data is limited. There is an urgent need to analyze data from larger and more homogeneous groups under more controlled conditions.
- Published
- 2019
- Full Text
- View/download PDF
43. Relationship Between Daily Dose, Serum Concentration, and Clinical Response to Quetiapine in Children and Adolescents with Psychotic and Mood Disorders.
- Author
-
Albantakis L, Egberts K, Burger R, Kulpok C, Mehler-Wex C, Taurines R, Unterecker S, Wewetzer C, Romanos M, and Gerlach M
- Subjects
- Adolescent, Child, Dose-Response Relationship, Drug, Drug Monitoring methods, Female, Humans, Male, Retrospective Studies, Statistics as Topic, Treatment Outcome, Antipsychotic Agents blood, Antipsychotic Agents therapeutic use, Mood Disorders drug therapy, Psychotic Disorders drug therapy, Quetiapine Fumarate blood, Quetiapine Fumarate therapeutic use
- Abstract
Introduction In child and adolescent psychiatry, therapeutic drug monitoring (TDM) is strongly recommended. However, therapeutic ranges (TR) are defined only for adults. The objectives of this naturalistic study were to assess the relationships between serum quetiapine concentration, daily dose, and clinical outcomes as well as the determinants of pharmacokinetic variability. Furthermore, it was elucidated whether the recommended TR for adult patients with psychotic disorders is valid for children and adolescents. Methods TDM was performed in 180 pediatric patients treated with quetiapine. Psychopathological changes were assessed by the Clinical Global Impression - Improvement scale (CGI-I). Adverse drug reactions (ADRs) were assessed by using a short form of the Udvalg for Kliniske Undersogelser (UKU) side effect rating scale. Results A weak positive linear relationship between daily dose (mean 349.9±248.9 mg/day) and serum concentration of quetiapine (r
s =0.496, p<0.001) was found (mean age 15.6±1.9 years, 45.6% male, 31.1% monotherapy), but no relationship between serum concentration and clinical outcome was found. Dose variation accounted for only 12.5% (rs 2 =0.125) of the variability of serum concentrations. No effects by gender, age, body weight, smoking habits, and co-medication were found. The majority of patients with psychotic (67.8%) and mood disorders (74.5%) showed a serum concentration below the suggested lower limit (100 ng/mL) of the TR for adults. Discussion There are several limitations of this study because of the naturalistic design, and our results should therefore be interpreted with caution. Notwithstanding, our data suggest that the lower limit of the TR for quetiapine is lower than the limit in adult patients., Competing Interests: Conflict of Interest: The authors report no conflict of interest., (© Georg Thieme Verlag KG Stuttgart · New York.)- Published
- 2017
- Full Text
- View/download PDF
44. Therapeutic Drug Monitoring in Children and Adolescents Under Pharmacotherapy With Olanzapine in Daily Clinical Practice.
- Author
-
Fekete S, Wewetzer C, Mehler-Wex C, Holtkamp K, Burger R, Reichert S, Taurines R, Romanos M, Gerlach M, and Egberts K
- Subjects
- Adolescent, Child, Dose-Response Relationship, Drug, Drug Monitoring methods, Female, Humans, Male, Olanzapine, Psychotic Disorders blood, Psychotropic Drugs blood, Psychotropic Drugs therapeutic use, Antipsychotic Agents blood, Antipsychotic Agents therapeutic use, Benzodiazepines blood, Benzodiazepines therapeutic use, Psychotic Disorders drug therapy
- Abstract
Background: The relationship between daily dose, serum concentrations, and clinical outcomes of olanzapine as well as the influencing factors thereof in children and adolescents treated for different psychiatric disorders were investigated in daily clinical practice. In addition, it was examined whether the current recommended therapeutic range (TR) for adult patients with psychotic disorders is valid for minors., Methods: The Competence Network for Therapeutic Drug Monitoring (www.tdm-kjp.com) routinely collects demographic and clinical outcome data as well as serum concentrations of children and adolescents treated with psychotropics. The therapeutic effect is documented using the Clinical Global Impression Scale subscale for Global Improvement. Adverse drug reactions (ADRs) are assessed using the Udvalg for Kliniske Undersogelser-Side Effect Rating Scale., Results: One hundred fifteen patients (mean age = 15.9 years; range = 10.4-18.8 years; 40.9% male) were included. The majority (72.1%) was cotreated with other psychotropic drugs. A positive medium linear relationship (r = 0.619; P < 0.001) between olanzapine dose (mean = 11.64 mg/d) and serum concentration (mean = 35.65 ng/mL) was found with a marked interindividual variability of serum concentrations. Neither relationship between olanzapine serum concentration and treatment response (clinical benefit documented in 80%) nor ADRs (documented in 53.3%, in 7.5% judged as severe) was detected. Most of the patients with psychotic and eating disorders (68.8% and 71.8%, respectively) had an olanzapine serum concentration within the TR suggested for adults., Conclusions: There are several limitations of this study because of the naturalistic design, and our results should therefore be interpreted with caution. As most of the patients showed a clinical benefit under olanzapine concentrations within the TR for adults and only a minority had severe ADRs, it is reasonable to conclude a similar TR for children, adolescents, and adults.
- Published
- 2017
- Full Text
- View/download PDF
45. Therapeutic drug monitoring as a measure of proactive pharmacovigilance in child and adolescent psychiatry.
- Author
-
Gerlach M, Egberts K, Dang SY, Plener P, Taurines R, Mehler-Wex C, and Romanos M
- Subjects
- Adolescent, Age Factors, Child, Dose-Response Relationship, Drug, Humans, Off-Label Use, Psychotropic Drugs adverse effects, Psychotropic Drugs pharmacokinetics, Drug Monitoring methods, Pharmacovigilance, Psychotropic Drugs administration & dosage
- Abstract
Introduction: Off-label or unlicensed use of psychotropic drugs is common rather than the exception in child and adolescent psychiatry. This use exposes patients to an unknown additional risk of ineffective or even harmful treatment. In addition, treatment with psychotropic drugs during a period of life when the patient undergoes marked developmental hormonal and neurobiological changes often requires different dosing regimes in later life and may result in adverse drug reactions, which are either not seen in adults at all or not in the same frequency. Areas covered: Given these critical safety issues, efficient pharmacovigilance methods as part of routine practice are essential for the improvement of patient care. The purpose of this article is to introduce methods to increase the safety of psychotropic drug use in youngsters. In particular, therapeutic drug monitoring (TDM) as a routine measure of proactive pharmacovigilance is discussed. Expert opinion: Given the special features of psychopharmacological therapy in children and adolescents in day-to-day clinical practise, proactive surveillance by using a close standardized 'patient monitoring' and long-term follow-up with TDM is very important. This approach could minimize the risk of exposing paediatric patients to ineffective treatments of uncertain or unknown risks.
- Published
- 2016
- Full Text
- View/download PDF
46. Relationship between clozapine dose, serum concentration, and clinical outcome in children and adolescents in clinical practice.
- Author
-
Wohkittel C, Gerlach M, Taurines R, Wewetzer C, Unterecker S, Burger R, Schreck D, Mehler-Wex C, Romanos M, and Egberts K
- Subjects
- Adolescent, Child, Clozapine blood, Dose-Response Relationship, Drug, Female, Humans, Longitudinal Studies, Male, Mental Disorders blood, Retrospective Studies, Treatment Outcome, Antipsychotic Agents blood, Antipsychotic Agents therapeutic use, Clozapine therapeutic use, Drug Monitoring methods, Mental Disorders drug therapy
- Abstract
Information on dose- and concentration-related clinical effects of clozapine treatment in children and adolescents is scarce. This study aimed to examine the relationship between dose, serum concentration, and clinical outcome as well as the influencing factors thereof in paediatric patients treated with clozapine. Data from a routine Therapeutic Drug Monitoring (TDM) service between 2004 and 2014 were studied in 68 patients, aged 11-18 years. Severity of illness, therapeutic effectiveness and adverse drug reactions (ADRs) were assessed by standardized means. A relationship between the daily dose (mean 319 mg, 4.9 mg/kg) and serum concentration (mean 387 ng/ml) of clozapine was found with the variation in dose explaining 30 % of the variability in clozapine serum concentrations. Also gender contributed to the variability, however, no influence of age or concomitant medications was detected. Furthermore, a significant association was found between clozapine serum concentration and the occurrence of ADRs. Patients without ADRs had a lower mean serum concentration than those with mild (261.4 vs 407.3 ng/ml, P = 0.018) and moderate ADRs (261.4 vs 416.3 ng/ml, P = 0.028). As clozapine was estimated to be effective in lower blood concentrations, guidance on a possibly lower therapeutic range of clozapine serum levels in paediatric patients is provided. With ADRs increasing under higher concentrations, TDM is strongly recommended in paediatric clozapine therapy for individualized dosing. Dose adjustment in females also might be reasonable according to gender-related differences in serum concentrations. However, regarding the limitations of this study results should be validated in larger studies with more standardized designs.
- Published
- 2016
- Full Text
- View/download PDF
47. Group-based cognitive behavioural psychotherapy for children and adolescents with ASD: the randomized, multicentre, controlled SOSTA-net trial.
- Author
-
Freitag CM, Jensen K, Elsuni L, Sachse M, Herpertz-Dahlmann B, Schulte-Rüther M, Hänig S, von Gontard A, Poustka L, Schad-Hansjosten T, Wenzl C, Sinzig J, Taurines R, Geißler J, Kieser M, and Cholemkery H
- Subjects
- Adolescent, Adult, Child, Female, Follow-Up Studies, Humans, Male, Sex Factors, Young Adult, Autism Spectrum Disorder therapy, Cognitive Behavioral Therapy methods, Outcome Assessment, Health Care, Psychotherapy, Group methods
- Abstract
Background: Group-based psychotherapy in Autism Spectrum Disorder (ASD) has predominantly been studied in the United States by small studies in school-aged children without long-term follow-up. We report results of a large, confirmatory, multicentre randomized-controlled phase-III trial in children and adolescents studying the ASD specific, manualized group-based cognitive behavioural SOSTA-FRA approach., Methods: High-functioning ASD individuals aged 8-19 years old were randomized to 12 sessions SOSTA-FRA or treatment as usual. Primary outcomes were change in total raw score of the parent-rated Social Responsiveness Scale (pSRS) between baseline (T2) and end of intervention (T4), and between T2 and 3 months after end of intervention (T5)., Trial Registration: ISRCTN94863788., Results: Between 20/5/2010 and 14/2/2013, n = 320 ASD patients were screened, n = 228 patients were randomized, and N = 209 analysed. Mean pSRS difference between groups at T4 was -6.5 (95% CI -11.6 to - 1.4; p = .013), and at T5 -6.4 (-11.5 to -1.3, p = .015). Pre-treatment SRS and IQ were positively associated with stronger improvement at T4 and T5., Conclusions: Short-term ASD-specific add-on group-based psychotherapy has shown postintervention efficacy with regard to parent-rated social responsiveness predominantly in male high-functioning children and adolescents with ASD. Future studies should implement blinded standardized observational measures of peer-related social interaction., (© 2015 Association for Child and Adolescent Mental Health.)
- Published
- 2016
- Full Text
- View/download PDF
48. CNTNAP2 gene in high functioning autism: no association according to family and meta-analysis approaches.
- Author
-
Werling AM, Bobrowski E, Taurines R, Gundelfinger R, Romanos M, Grünblatt E, and Walitza S
- Subjects
- Adolescent, Case-Control Studies, Child, Child, Preschool, Female, Genetic Predisposition to Disease genetics, Genotype, Humans, Male, Polymerase Chain Reaction, Polymorphism, Single Nucleotide, Siblings, Autistic Disorder genetics, Membrane Proteins genetics, Nerve Tissue Proteins genetics
- Abstract
The Contactin Associated Protein-like 2 (CNTNAP2) gene has been discussed to be associated with different symptoms of autism spectrum disorders (ASDs) and other neurodevelopmental disorders. We aimed to elucidate the genetic association of CNTNAP2 within high functioning ASD (HFA), focusing on autism specific symptoms and reducing intelligence related factors. Furthermore, we compared our findings conducting a meta-analysis in patients with ASD and HFA only. A case-control association study was performed for HFA (HFA, n = 105; controls, n = 133). Moreover, we performed a family-based association study (DFAM) analysis (HFA, n = 44; siblings, n = 57). Individuals were genotyped for the two most frequently reported single nucleotide polymorphisms (SNPs) in the CNTNAP2 gene (rs2710102, rs7794745). Furthermore, a meta-analysis using the MIX2 software integrated our results with previously published data. A significant association for the carriers of the T-allele of the rs7794745 with HFA was found in the case-control sample [OR = 1.547; (95 % CI 1.056-2.266); p = 0.025]. No association could be found by DFAM with any of the CNTNAP2 SNPs with HFA. The meta-analysis of both SNPs did not show a significant association with either ASD or with HFA. Overall, including case-control, sibs, and meta-analysis, we could not detect any significant association with the CNTNAP2 gene and HFA. Our results point in the direction that CNTNAP2 may not play a major role in HFA, but rather seems to have a significance in neurodevelopmental disorders or in individuals displaying intellectual delays.
- Published
- 2016
- Full Text
- View/download PDF
49. Neurotrophin blood-based gene expression and social cognition analysis in patients with autism spectrum disorder.
- Author
-
Segura M, Pedreño C, Obiols J, Taurines R, Pàmias M, Grünblatt E, and Gella A
- Subjects
- Adolescent, Adult, Biomarkers blood, Brain-Derived Neurotrophic Factor genetics, Child, Female, Gene Expression, Humans, Male, Middle Aged, Neurotrophin 3 genetics, RNA, Messenger blood, Receptor, trkA genetics, Receptor, trkB genetics, Young Adult, Autism Spectrum Disorder blood, Nerve Growth Factors genetics, Nerve Tissue Proteins genetics, Receptor Protein-Tyrosine Kinases genetics, Receptors, Nerve Growth Factor genetics, Theory of Mind
- Abstract
Autism spectrum disorders (ASD) comprise neurodevelopmental disorders with clinical onset during the first years of life. The identification of peripheral biomarkers could significantly impact diagnosis and an individualized, early treatment. Although the aetiology of ASD remains poorly understood, there is increasing evidence that neurotrophins and their receptors represent a group of candidate genes for ASD pathophysiology and biomarker research. Total messenger RNA (mRNA) from whole blood was obtained from adolescents and adults diagnosed as ASD (n = 21) according to DSM-IV criteria and confirmed by the Autism Diagnostic Observation Schedule (ADOS) and Autism Diagnostic Interview-Revised (ADI-R) algorithms, as well as healthy controls (n = 10). The mRNA expression of neurotrophins (BDNF, NT3 and NT4) and their receptors (TrkA, TrkB and p75 (NTR) ) was determined by quantitative real-time polymerase chain reaction (qRT-PCR). Moreover, social cognition abilities of ASD patients and controls were determined according to three Theory of Mind (ToM) tests (Reading the Mind in the Eyes, Faux pas, and Happé stories). The NT3 and NT4 mRNA expression in the whole blood was significantly lower in ASD compared to healthy controls, while p75(NTR) was higher (P < 0.005). In addition, lower scores in three of the ToM tests were observed in ASD subjects compared to controls. A significant (P < 0.005) ToM impairment in Happé stories test was demonstrated in ASD. Nevertheless, no correlations were observed between neurotrophins and their receptors expressions and measures of ToM. Given their potential as peripheral blood-based biomarkers, NT3, NT4 and p75 (NTR) mRNA expression patterns may be useful tools for a more personalized diagnostics and therapy in ASD. Further investigations with larger numbers of samples are needed to verify these results.
- Published
- 2015
- Full Text
- View/download PDF
50. [Pharmacovigilance in child and adolescent psychiatry].
- Author
-
Egberts K, Karwautz A, Plener PL, Mehler-Wex C, Kölch M, Dang SY, Taurines R, Romanos M, and Gerlach M
- Subjects
- Adolescent, Adverse Drug Reaction Reporting Systems, Child, Drug Monitoring, Germany, Humans, Mental Disorders blood, Mental Disorders diagnosis, Mental Disorders psychology, Practice Patterns, Physicians', Psychotropic Drugs pharmacokinetics, Quality Assurance, Health Care, Treatment Outcome, Mental Disorders drug therapy, Psychotropic Drugs adverse effects, Psychotropic Drugs therapeutic use
- Abstract
Rational pharmacotherapy is a challenging task in child and adolescent psychiatry. Increasing prescription numbers contrast with the uncertainties of safety and efficacy issues. The lack of clinical (authorization) trials often implies a non- age-specific use of drugs. However, young patients show particular metabolic conditions and a higher vulnerability for adverse drug reactions. Thus it seems mandatory to create age-specific pharmacological data about efficacy and safety of psychotropic drug use in minors. Legislation authorities became aware of this situation and introduced European and national scientific pharmacovigilance regulations and programmes accordingly in order to continuously evaluate the benefit-risk-ratio, detect, collect, minimize, and prevent adverse effects of drugs by appropriate measures, e.g., therapeutic drug monitoring. In this paper the principles and needs of pharmacovigilance in child and adolescent psychiatry are discussed. Furthermore a large multicenter clinical trial («TDM-VIGIL»), funded by the German Federal Institute for Drugs and Medical Devices, is presented, which appeals to collect epidemiological prescription and safety data of psychotropic drugs in children and adolescents using an internet-based data infrastructure (patient registry).
- Published
- 2015
- Full Text
- View/download PDF
Catalog
Discovery Service for Jio Institute Digital Library
For full access to our library's resources, please sign in.