Taurines, Regina and Gerlach, Manfred and Correll, Christoph U. and Plener, Paul L. and Malzahn, Uwe and Heuschmann, Peter and Scherf-Clavel, Maike and Rock, Hans and Briegel, Wolfgang and Fleischhaker, Christian and Hage, Alexander and Hellenschmidt, Tobias and Imgart, Hartmut and Kaess, Michael and Karwautz, Andreas and Kolch, Michael and Reitzle, Karl and Renner, Tobias J. and Reuter-Dang, Su-Yin and Rexroth, Christian and Schulte-Korne, Gerd and Theisen, Frank and Tini, Elvira and Wewetzer, Christoph and Fekete, Stefanie and Romanos, Marcel and Egberts, Karin M. (2025) Off-label drug use in children and adolescents treated with antidepressants and antipsychotics: results from a prospective multicenter trial. CHILD AND ADOLESCENT PSYCHIATRY AND MENTAL HEALTH, 19 (1): 110. ISSN , 1753-2000
Full text not available from this repository. (Request a copy)Abstract
Background/Objectives Off-label psychopharmacologic medication use is widespread in child and adolescent psychiatry, but little is known about its associated factors. This study aimed to assess frequency and determinants of off-label use of antidepressants and antipsychotics in youths in daily clinical practice. Methods In a prospective clinical study ('TDM-VIGIL') at 18 centers in three German-speaking countries, child psychiatric patients aged 4-18 years undergoing routine treatment with antidepressants and antipsychotics were systematically followed. Demographic, clinical and pharmacological data were collected in an online-based patient registry; off-label use was categorized by reasons, including age, indication or duration of treatment for each treatment episode. Examined correlates of off-label use included sex, treatment setting, diagnosis and illness severity. Results About 67% of all antidepressant and antipsychotic treatment episodes in the 700 included patients (mean age = 14.6 years, girls = 67%) were off-label. For antidepressants, 55.2% were off-label (age = 51.1%, non-licensed indications = 37.4%, age + indication = 11.5%), for antipsychotics 81.7% were off-label (age = 29.4%, non-licensed indications = 33.2%, age + indication = 37.4%). Sex, age (< 12, >= 12 years) as well as illness severity were not associated with off-label use. In antidepressant treatment, 'depression' and 'obsessive compulsive disorder' diagnoses were associated with reduced and 'suicidality at admission' with increased off-label prescriptions. In antipsychotics, 'schizophrenia diagnoses' was linked to decreased, university hospital treatment to increased off-label use. Conclusions The frequency of off-label use of antidepressants and even more of antipsychotics in youths treated at specialized child psychiatric centers is high. As the clinical efficacy and safety of off-label antidepressant and antipsychotic use in youth is under-researched, our results call for further pharmacovigilance studies and strategies to improve drug safety.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | PSYCHOTROPIC MEDICATIONS; NATIONAL TRENDS; PRACTICE PATTERNS; YOUTH; PRESCRIPTIONS; GERMANY; DANISH; ADULTS; EXTENT; DISORDERS; Off-label drug use; Children; Adolescents; Antidepressants; Antipsychotics; Depression; Obsessive compulsive disorder; Schizophrenia |
| Subjects: | 100 Philosophy & psychology > 150 Psychology 600 Technology > 610 Medical sciences Medicine |
| Divisions: | Medicine > Lehrstuhl für Kinder- und Jugendpsychiatrie |
| Depositing User: | Dr. Gernot Deinzer |
| Date Deposited: | 24 Mar 2026 07:37 |
| Last Modified: | 24 Mar 2026 07:37 |
| URI: | https://pred.uni-regensburg.de/id/eprint/68069 |
Actions (login required)
 |
View Item |
