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Egberts, Karin M.
[VerfasserIn];
Gerlach, Manfred
[VerfasserIn];
Correll, Christoph U.
[VerfasserIn];
Plener, Paul L.
[VerfasserIn];
Malzahn, Uwe
[VerfasserIn];
Heuschmann, Peter
[VerfasserIn];
Unterecker, Stefan
[VerfasserIn];
Scherf-Clavel, Maike
[VerfasserIn];
Rock, Hans
[VerfasserIn];
Antony, Gisela
[VerfasserIn];
Briegel, Wolfgang
[VerfasserIn];
Fleischhaker, Christian
[VerfasserIn];
Häge, Alexander
[VerfasserIn];
Hellenschmidt, Tobias
[VerfasserIn];
Imgart, Harmut
[VerfasserIn];
Kaess, Michael
[VerfasserIn];
Karwautz, Andreas
[VerfasserIn];
Kölch, Michael
[VerfasserIn];
Reitzle, Karl
[VerfasserIn];
Renner, Tobias
[VerfasserIn];
Reuter-Dang, Su-Yin
[VerfasserIn];
Rexroth, Christian A.
[VerfasserIn];
Schulte-Körne, Gerd
[VerfasserIn];
Theisen, Frank M.
[VerfasserIn];
[...]
Serious adverse drug reactions in children and adolescents treated on- and off-label with antidepressants and antipsychotics in clinical practice
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- Medientyp: E-Artikel
- Titel: Serious adverse drug reactions in children and adolescents treated on- and off-label with antidepressants and antipsychotics in clinical practice
- Beteiligte: Egberts, Karin M. [VerfasserIn]; Gerlach, Manfred [VerfasserIn]; Correll, Christoph U. [VerfasserIn]; Plener, Paul L. [VerfasserIn]; Malzahn, Uwe [VerfasserIn]; Heuschmann, Peter [VerfasserIn]; Unterecker, Stefan [VerfasserIn]; Scherf-Clavel, Maike [VerfasserIn]; Rock, Hans [VerfasserIn]; Antony, Gisela [VerfasserIn]; Briegel, Wolfgang [VerfasserIn]; Fleischhaker, Christian [VerfasserIn]; Häge, Alexander [VerfasserIn]; Hellenschmidt, Tobias [VerfasserIn]; Imgart, Harmut [VerfasserIn]; Kaess, Michael [VerfasserIn]; Karwautz, Andreas [VerfasserIn]; Kölch, Michael [VerfasserIn]; Reitzle, Karl [VerfasserIn]; Renner, Tobias [VerfasserIn]; Reuter-Dang, Su-Yin [VerfasserIn]; Rexroth, Christian A. [VerfasserIn]; Schulte-Körne, Gerd [VerfasserIn]; Theisen, Frank M. [VerfasserIn]; Walitza, Susanne [VerfasserIn]; Wewetzer, Christoph [VerfasserIn]; Fekete, Stefanie [VerfasserIn]; Taurines, Regina [VerfasserIn]; Romanos, Marcel [VerfasserIn]
- Erschienen: 1 September 2022
- Erschienen in: Pharmacopsychiatry ; 55(2022), 5, Seite 255-265
- Sprache: Englisch
- DOI: 10.1055/a-1716-1856
- ISSN: 1439-0795
- Identifikator:
- Entstehung:
- Anmerkungen:
- Beschreibung: 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.
- Zugangsstatus: Freier Zugang