Egberts, Karin M., Gerlach, Manfred, Correll, Christoph U., Plener, Paul L., Malzahn, Uwe, Heuschmann, Peter, Unterecker, Stefan, Scherf-Clavel, Maike, Rock, Hans, Antony, Gisela, Briegel, Wolfgang, Fleischhaker, Christian, Hage, Alexander, Hellenschmidt, Tobias, Imgart, Harmut, Kaess, Michael ORCID: 0000-0003-0031-7764, Karwautz, Andreas, Kolch, Michael, Reitzle, Karl, Renner, Tobias, Reuter-Dang, Su-Yin, Rexroth, Christian, Schulte-Korne, Gerd, Theisen, Frank M., Walitza, Susanne ORCID: 0000-0002-8161-8683, Wewetzer, Christoph, Fekete, Stefanie, Taurines, Regina and Romanos, Marcel ORCID: 0000-0001-7628-8299 (2022). Serious Adverse Drug Reactions in Children and Adolescents Treated On- and Off-Label with Antidepressants and Antipsychotics in Clinical Practice. Pharmacopsychiatry, 55 (5). S. 255 - 266. STUTTGART: GEORG THIEME VERLAG KG. ISSN 1439-0795

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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.

Item Type: Journal Article
Creators:
CreatorsEmailORCIDORCID Put Code
Egberts, Karin M.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Gerlach, ManfredUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Correll, Christoph U.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Plener, Paul L.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Malzahn, UweUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Heuschmann, PeterUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Unterecker, StefanUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Scherf-Clavel, MaikeUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Rock, HansUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Antony, GiselaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Briegel, WolfgangUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Fleischhaker, ChristianUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Hage, AlexanderUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Hellenschmidt, TobiasUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Imgart, HarmutUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kaess, MichaelUNSPECIFIEDorcid.org/0000-0003-0031-7764UNSPECIFIED
Karwautz, AndreasUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kolch, MichaelUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Reitzle, KarlUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Renner, TobiasUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Reuter-Dang, Su-YinUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Rexroth, ChristianUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Schulte-Korne, GerdUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Theisen, Frank M.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Walitza, SusanneUNSPECIFIEDorcid.org/0000-0002-8161-8683UNSPECIFIED
Wewetzer, ChristophUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Fekete, StefanieUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Taurines, ReginaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Romanos, MarcelUNSPECIFIEDorcid.org/0000-0001-7628-8299UNSPECIFIED
URN: urn:nbn:de:hbz:38-696555
DOI: 10.1055/a-1716-1856
Journal or Publication Title: Pharmacopsychiatry
Volume: 55
Number: 5
Page Range: S. 255 - 266
Date: 2022
Publisher: GEORG THIEME VERLAG KG
Place of Publication: STUTTGART
ISSN: 1439-0795
Language: English
Faculty: Unspecified
Divisions: Unspecified
Subjects: no entry
Uncontrolled Keywords:
KeywordsLanguage
UNTREATED PSYCHIATRIC-DISORDERS; SAFETY; PHARMACOVIGILANCE; MEDICATIONS; RELEVANCE; DURATION; GERMANY; TRIALSMultiple languages
Pharmacology & Pharmacy; PsychiatryMultiple languages
URI: http://kups.ub.uni-koeln.de/id/eprint/69655

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