Therapeutic Drug Monitoring in Children and Adolescents: Findings on Fluoxetine from the TDM-VIGIL Trial.

TDM adolescents antidepressants depression pharmacovigilance reference range selective serotonin reuptake inhibitors steady-state concentration

Journal

Pharmaceutics
ISSN: 1999-4923
Titre abrégé: Pharmaceutics
Pays: Switzerland
ID NLM: 101534003

Informations de publication

Date de publication:
25 Aug 2023
Historique:
received: 19 07 2023
revised: 18 08 2023
accepted: 19 08 2023
medline: 28 9 2023
pubmed: 28 9 2023
entrez: 28 9 2023
Statut: epublish

Résumé

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 (

Identifiants

DOI: 10.3390/pharmaceutics15092202 PMID: 37765171 PMC: PMC10534581
pubmed: 37765171
pii: pharmaceutics15092202
doi: 10.3390/pharmaceutics15092202
pmc: PMC10534581
pii:
doi:

Types de publication

Journal Article

Langues

eng

Subventions

Organisme : Federal Institute for Drugs and Medical Devices
ID : V-15322/68605/2013-2018
Organisme : Federal Ministry of Education and Research
ID : 001EZ0937

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Auteurs

Michael Frey (M)

Faculty of Applied Healthcare Science, Deggendorf Institute of Technology, 94469 Deggendorf, Germany.
Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, University Hospital, LMU Munich, 80097 Munich, Germany.
ORCID: 0000-0001-5824-6757

Lukasz Smigielski (L)

Department of Child and Adolescent Psychiatry and Psychotherapy, Psychiatric University Hospital Zurich, University of Zurich, 8032 Zürich, Switzerland.

Elvira Tini (E)

Department of Child and Adolescent Psychiatry and Psychotherapy, Psychiatric University Hospital Zurich, University of Zurich, 8032 Zürich, Switzerland.

Stefanie Fekete (S)

Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, Center for Mental Health, University Hospital of Wuerzburg, 97080 Wuerzburg, Germany.

Christian Fleischhaker (C)

Department of Child and Adolescent Psychiatry and Psychotherapy, University Medical Center Freiburg, 79104 Freiburg, Germany.

Christoph Wewetzer (C)

KIRINUS Tagesklinik Kinder und Jugendliche, 80639 Munich, Germany.

Andreas Karwautz (A)

Department of Child and Adolescent Psychiatry, Medical University Vienna, 1090 Vienna, Austria.
ORCID: 0000-0001-9053-998X

Christoph U Correll (CU)

Department of Child and Adolescent Psychiatry, Charité Universitätsmedizin Berlin, 13353 Berlin, Germany.
Department of Psychiatry, The Zucker Hillside Hospital, Northwell Health, Glen Oaks, NY 11004, USA.
Department of Psychiatry and Molecular Medicine, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Hempstead, NY 11549, USA.
ORCID: 0000-0002-7254-5646

Manfred Gerlach (M)

Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, Center for Mental Health, University Hospital of Wuerzburg, 97080 Wuerzburg, Germany.

Regina Taurines (R)

Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, Center for Mental Health, University Hospital of Wuerzburg, 97080 Wuerzburg, Germany.

Paul L Plener (PL)

Department of Child and Adolescent Psychiatry, Medical University Vienna, 1090 Vienna, Austria.
Department of Child and Adolescent Psychiatry/Psychotherapy, University Hospital Ulm, 89075 Ulm, Germany.

Uwe Malzahn (U)

Clinical Trial Center Wuerzburg, University Hospital Wuerzburg, 97080 Wuerzburg, Germany.

Selina Kornbichler (S)

Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, University Hospital, LMU Munich, 80097 Munich, Germany.

Laura Weninger (L)

Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, University Hospital, LMU Munich, 80097 Munich, Germany.

Matthias Brockhaus (M)

Max-Planck-Institut für Psychiatry, 80804 Munich, Germany.

Su-Yin Reuter-Dang (SY)

Specialist Practice and Medical Care Centre for Child and Adolescent Psychiatry Munich, Dr. Epple & Dr. Reuter-Dang, 81241 Munich, Germany.

Karl Reitzle (K)

Specialist Practice and Medical Care Center for Child and Adolescent Psychiatry Munich, 81241 Munich, Germany.

Hans Rock (H)

Central Information Office, Department of Neurology, Philipps University of Marburg, 35112 Marburg, Germany.

Hartmut Imgart (H)

Parkland-Clinic, Clinic for Psychosomatics and Psychotherapy, Academic Teaching Hospital for the University Gießen, 34537 Bad Wildungen, Germany.

Peter Heuschmann (P)

Clinical Trial Center Wuerzburg, University Hospital Wuerzburg, 97080 Wuerzburg, Germany.
Institute of Clinical Epidemiology and Biometry, University of Wuerzburg, 97080 Wuerzburg, Germany.
ORCID: 0000-0002-2681-3515

Stefan Unterecker (S)

Department of Psychiatry, Psychosomatics and Psychotherapy, Center of Mental Health, University Hospital of Wuerzburg, 97080 Wuerzburg, Germany.

Wolfgang Briegel (W)

Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, Center for Mental Health, University Hospital of Wuerzburg, 97080 Wuerzburg, Germany.
Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, Leopoldina Hospital, 97422 Schweinfurt, Germany.
ORCID: 0000-0002-8253-5070

Tobias Banaschewski (T)

Department of Child and Adolescent Psychiatry and Psychotherapy, Central Institute of Mental Health, Medical Faculty Mannheim, Heidelberg University, 68159 Mannheim, Germany.
ORCID: 0000-0003-4595-1144

Jörg M Fegert (JM)

Department of Child and Adolescent Psychiatry/Psychotherapy, University Hospital Ulm, 89075 Ulm, Germany.

Tobias Hellenschmidt (T)

Department of Child and Adolescent Psychiatry, Psychotherapy and Psychosomatic medicine, Vivantes Clinic Berlin Neukölln, 12351 Berlin, Germany.

Michael Kaess (M)

Clinic for Child and Adolescent Psychiatry, Center for Psychosocial Medicine, University Hospital Heidelberg, 69115 Heidelberg, Germany.
University Hospital of Child and Adolescent Psychiatry and Psychotherapy, University of Bern, 3000 Bern, Switzerland.

Michael Kölch (M)

Department of Child and Adolescent Psychiatry and Psychotherapy, Brandenburg Medical School Brandenburg, 16816 Neuruppin, Germany.
Department of Child and Adolescent Psychiatry, Neurology, Psychosomatics, and Psychotherapy, University Medical Center Rostock, 18147 Rostock, Germany.
ORCID: 0000-0003-2878-5121

Tobias Renner (T)

Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, University Hospital of Psychiatry and Psychotherapy Tuebingen, Center of Mental Health Tuebingen, 72076 Tuebingen , Germany.

Christian Rexroth (C)

Clinic for Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, University of Regensburg at the Regensburg District Hospital, Medbo KU, 93053 Regensburg, Germany.
ORCID: 0009-0007-4562-0894

Susanne Walitza (S)

Department of Child and Adolescent Psychiatry and Psychotherapy, Psychiatric University Hospital Zurich, University of Zurich, 8032 Zürich, Switzerland.
Zurich Center for Integrative Human Physiology, University of Zurich, 8057 Zürich, Switzerland.
Neuroscience Center Zurich, University of Zurich and ETH, 8057 Zürich, Switzerland.

Gerd Schulte-Körne (G)

Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, University Hospital, LMU Munich, 80097 Munich, Germany.

Marcel Romanos (M)

Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, Center for Mental Health, University Hospital of Wuerzburg, 97080 Wuerzburg, Germany.
ORCID: 0000-0001-7628-8299

Karin Maria Egberts (KM)

Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, Center for Mental Health, University Hospital of Wuerzburg, 97080 Wuerzburg, Germany.
ORCID: 0000-0002-0270-0954

Classifications MeSH