; Plener, Paul L.
; Malzahn, Uwe ; Heuschmann, Peter ; Unterecker, Stefan ; Scherf-Clavel, Maike ; Rock, Hans ; Antony, Gisela ; Briegel, Wolfgang ; Fleischhaker, Christian ; Häge, Alexander ; Hellenschmidt, Tobias ; Imgart, Harmut ; Kaess, Michael
; Karwautz, Andreas ; Kölch, Michael ; Reitzle, Karl ; Renner, Tobias ; Reuter-Dang, Su-Yin ; Rexroth, Christian ; Schulte-Körne, Gerd ; Theisen, Frank M. ; Walitza, Susanne
; Wewetzer, Christoph ; Fekete, Stefanie ; Taurines, Regina ; Romanos, Marcel 
| Item type: | Article | ||||
|---|---|---|---|---|---|
| Journal or Publication Title: | Pharmacopsychiatry | ||||
| Publisher: | GEORG THIEME VERLAG KG | ||||
| Place of Publication: | STUTTGART | ||||
| Volume: | 55 | ||||
| Number of Issue or Book Chapter: | 05 | ||||
| Page Range: | pp. 255-265 | ||||
| Date: | 2022 | ||||
| Institutions: | Medicine > Lehrstuhl für Psychiatrie und Psychotherapie | ||||
| Identification Number: |
| ||||
| Keywords: | UNTREATED PSYCHIATRIC-DISORDERS; SAFETY; PHARMACOVIGILANCE; MEDICATIONS; RELEVANCE; DURATION; GERMANY; TRIALS; antidepressants; antipsychotics; child; adverse drug reactions; safety | ||||
| Dewey Decimal Classification: | 600 Technology > 610 Medical sciences Medicine | ||||
| Status: | Published | ||||
| Refereed: | Yes, this version has been refereed | ||||
| Created at the University of Regensburg: | Yes | ||||
| Item ID: | 57770 |
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 ...

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.
Metadata last modified: 29 Feb 2024 13:02
Altmetric