Pharmacopsychiatry 2022; 55(03): 170-172
DOI: 10.1055/s-0042-1747663
Abstracts | XIVth Symposium of the Task Force Therapeutic Drug Monitoring of the AGNP

Therapeutic drug monitoring of sertraline in pediatric population: A naturalistic study with insights into the clinical response of obsessive-compulsive disorder

E. Tini
1   Department of Child and Adolescent Psychiatry and Psychotherapy, Psychiatric University Hospital Zurich, University of Zurich, Zürich, Switzerland
,
L. Smigielski
1   Department of Child and Adolescent Psychiatry and Psychotherapy, Psychiatric University Hospital Zurich, University of Zurich, Zürich, Switzerland
,
M. Romanos
2   Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, Center for Mental Health, University Hospital of Wuerzburg, Wuerzburg, Germany
,
C. Wewetzer
3   Kliniken der Stadt Köln GmbH, Clinic for Child and Adolescent Psychiatry Holweide, Children's Hospital Amsterdamer Straße, Cologne, Germany
,
A. Karwautz
4   Department of Child and Adolescent Psychiatry, Medical University Vienna, Vienna, Austria
,
K. Reitzle
5   Specialist practice and Medical Care Center for Child and Adolescent Psychiatry Munich, Munich, Germany
,
C.U. Correll
6   Department of Child and Adolescent Psychiatry, Charité Universitätsmedizin Berlin, Berlin, Germany
7   The Zucker Hillside Hospital, Department of Psychiatry, Northwell Health, Glen Oaks, NY, USA
8   Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Department of Psychiatry and Molecular Medicine, Hempstead, NY, USA
,
P.L. Plener
9   Department of Child and Adolescent Psychiatry/Psychotherapy, University Hospital Ulm, Ulm, Germany
10   Department of Child and Adolescent Psychiatry, Medical University Vienna, Vienna, Austria
,
U. Malzahn
11   Clinical Trial Center Wuerzburg, University Hospital Wuerzburg, Wuerzburg, Germany
,
P. Heuschmann
11   Clinical Trial Center Wuerzburg, University Hospital Wuerzburg, Wuerzburg, Germany
12   Institute of Clinical Epidemiology and Biometry, University of Wuerzburg, Germany
,
S. Unterecker
13   Department of Psychiatry, Psychosomatics and Psychotherapy, Center of Mental Health, University Hospital Wuerzburg, Wuerzburg, Germany
,
M. Scherf-Clavel
13   Department of Psychiatry, Psychosomatics and Psychotherapy, Center of Mental Health, University Hospital Wuerzburg, Wuerzburg, Germany
,
H. Rock
14   Central Information Office, Department of Neurology, Philipps University of Marburg, Marburg, Germany
,
G. Antony
14   Central Information Office, Department of Neurology, Philipps University of Marburg, Marburg, Germany
,
W. Briegel
2   Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, Center for Mental Health, University Hospital of Wuerzburg, Wuerzburg, Germany
15   Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, Leopoldina Hospital, Schweinfurt, Germany
,
C. Fleischhaker
16   Department of Child and Adolescent Psychiatry and Psychotherapy, University Medical Center Freiburg, Freiburg, Germany
,
T. Banaschewski
17   Department of Child and Adolescent Psychiatry and Psychotherapy, Central Institute of Mental Health, Medical Faculty Mannheim, Heidelberg University, Mannheim, Germany
,
T. Hellenschmidt
18   Department of Child and Adolescent Psychiatry, Psychotherapy and Psychosomatic medicine, Vivantes Clinic Berlin Neukölln, Berlin, Germany
,
H. Imgart
19   Parkland-Clinic, Clinic for Psychosomatics and Psychotherapy, academic teaching hospital for the University Gießen, Bad Wildungen, Germany
,
M. Kaess
20   Clinic for Child and Adolescent Psychiatry, Center for Psychosocial Medicine, University Hospital Heidelberg, Heidelberg, Germany
21   University Hospital of Child and Adolescent Psychiatry and Psychotherapy, University of Bern, Bern, Switzerland
,
M. Kölch
22   Department of Child and Adolescent Psychiatry and Psychotherapy, Brandenburg Medical School Brandenburg, Neuruppin, Germany
23   Department of Child and Adolescent Psychiatry, Neurology, Psychosomatics, and Psychotherapy, University Medical Center Rostock, Rostock, Germany
,
T. Renner
24   Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, University Hospital of Psychiatry and Psychotherapy Tuebingen, Center of Mental Health Tuebingen, Germany
,
S.Y. Reuter-Dang
2   Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, Center for Mental Health, University Hospital of Wuerzburg, Wuerzburg, Germany
25   Specialist practice and Medical Care Center for Child and Adolescent Psychiatry Munich, Munich, Germany
,
C. Rexroth
26   Clinic for Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, University of Regensburg at the Regensburg District Hospital, medbo KU, Regensburg, Germany
,
G. Schulte-Körne
27   Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, Ludwig-Maximilians-University (LMU) Hospital, Munich, Germany
,
F. Theisen
28   Department of Child and Adolescent Psychiatry and Psychotherapy, Herz-Jesu-Krankenhaus gGmbH, Fulda, Germany
,
S. Fekete
2   Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, Center for Mental Health, University Hospital of Wuerzburg, Wuerzburg, Germany
,
R. Taurines
2   Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, Center for Mental Health, University Hospital of Wuerzburg, Wuerzburg, Germany
,
M. Gerlach
2   Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, Center for Mental Health, University Hospital of Wuerzburg, Wuerzburg, Germany
,
K.M. Egberts
2   Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, Center for Mental Health, University Hospital of Wuerzburg, Wuerzburg, Germany
,
S. Walitza
1   Department of Child and Adolescent Psychiatry and Psychotherapy, Psychiatric University Hospital Zurich, University of Zurich, Zürich, Switzerland
29   Zurich Center for Integrative Human Physiology, University of Zurich, Zürich, Switzerland
30   Neuroscience Center Zurich, University of Zurich and ETH, Zurich, Switzerland
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*Equal contribution

Introduction Sertraline is the first-line medication for treatment of pediatric anxiety, depression and early-onset obsessive-compulsive disorder (OCD). Owing to complex etiologies underlying psychiatric disorders and differing metabolisms, relationship between pharmacokinetics, pharmacodynamics, efficacy, and tolerability of sertraline across indications and in individual cases, particularly in non-adult patients, is not fully understood.

Methods This therapeutic drug monitoring (TDM) study was implemented in a transdiagnostic sample of children and adolescents (n=78; mean age, 14.22±2.39; range, 7–18 years) treated with sertraline, as part of the international “TDM-VIGIL” project. Associations between dose, serum concentration, medication-specific therapeutic and side effects measured by an adapted Clinical Global Impression scale were investigated. The 56-item Pediatric Adverse Event Rating Scale served to assess drug tolerability.

Results The analysis showed a linear positive association between dose and serum concentration, with dose explaining 45% of the variance in concentration, as well as significant effects of weight and co-medication. Neither dose nor serum concentration were associated with side effects transdiagnostically, and overall a mild-to-moderate tolerability profile was reported. Notably, when split into depression (MDD) and OCD diagnoses, the probability of clinical improvement significantly increased with both higher doses and higher resulting concentrations, unlike for MDD.

Conclusions This study revealed a significant diagnosis-specific effect between sertraline serum concentration and clinical efficacy for pediatric OCD. Possibly, sertraline-related improvements in OCD are not dependent on the short-term availability of serotonin, but rather on long-term postsynaptic changes. TDM may be a valuable discovery tool in psychiatry and may facilitate a personalized medicine approach.

Conflict of Interest 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). 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. TB received personal fees from Lundbeck, Medice, Neurim Pharmaceuticals, Oberberg GmbH, Takeda, Infectopharm, and Eli Lilly; serving as an advisor or consultant to Bristol Myers Squibb, Desitin Arzneimittel, Eli Lilly, Medice, Novartis, Pfizer, Shire, UCB, and Vifor Pharma; receiving conference attendance support, conference support, or speaking fees from Eli Lilly, Janssen McNeil, Medice, Novartis, Shire, and UCB; being involved in clinical trials conducted by Eli Lilly, Novartis, and Shire; and receiving royalties from Hogrefe, Kohlhammer, CIP-Medien, and Oxford University Press. SW has received in the last 5 years royalties from Thieme, Hogrefe, Kohlhammer, E. Tini et al. Comprehensive Psychiatry 115 (2022) 152301 9 Springer, 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, Gesundheitsforderung Schweiz. The other authors (ET, LS, CW, AK, KR, UM, SU, MS, HR, GA, WB, CF, TH, HI, MKae, MKo, TR, SR, CR, GS, FT, and SF) declare no conflict of interest.



Publication History

Article published online:
16 May 2022

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