A2 Refereed review article in a scientific journal

Systematic review: Efficacy of off-label antipsychotic use in children and adolescents with obsessive-compulsive, mood dysregulation, depression, anxiety, and sleep-related disorders;




AuthorsHolopainen, Akseli K.; Vainiotalo, Pyry A.; Arrhenius, Bianca P.; Ringbom, Ida; Laurila, Mirja; Gyllenberg, David

PublisherSpringer Science and Business Media LLC

Publication year2026

Journal: European Child and Adolescent Psychiatry

ISSN1018-8827

eISSN1435-165X

DOIhttps://doi.org/10.1007/s00787-026-03049-9

Publication's open availability at the time of reportingOpen Access

Publication channel's open availability Partially Open Access publication channel

Web address https://doi.org/10.1007/s00787-026-03049-9

Self-archived copy’s web addresshttps://research.utu.fi/converis/portal/detail/Publication/524884837

Self-archived copy's licenceCC BY

Self-archived copy's versionPublisher`s PDF


Abstract

Antipsychotics (APs) are not officially approved for the treatment of depressive, anxiety, obsessive-compulsive, emotional dysregulation, or sleep disorders among children and adolescents. Despite this, the treatment of these common and comorbid disorders is likely to partially explain the increased AP use. We assessed all studies reporting changes in symptoms or functioning during antipsychotic treatment for these diagnoses among patients < 18 years old. We systematically searched MEDLINE, EBM reviews and PsycINFO databases for all studies published by October 30, 2025, reporting on the effectiveness of APs for obsessive-compulsive, mood dysregulation, depression, anxiety, and sleep-related disorders among patients < 18 years. We evaluated evidence using the Grading of Recommendations Assessment, Development and Evaluation approach (GRADE). Of the 2237 identified studies, 119 were eligible for full-text review, and 13 were included in the final review. One study compared two antipsychotics, while the rest were uncontrolled open-label studies, case series, or case reports. No randomized controlled trials nor studies on sleep or anxiety disorders were identified. While there were reported changes in standardized mean scores between baseline and endpoint, the level of evidence in obsessive-compulsive, mood dysregulation, and depression related disorders was very low. The identified very low level of evidence stands in stark contrast to clinical practice, where APs are increasingly prescribed. Future methodologically robust studies are needed to demonstrate efficacy. Given the side effects of APs, physicians should carefully consider the benefits and harms when prescribing them for off-label indications.


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Funding information in the publication
Open Access funding provided by University of Helsinki (including Helsinki University Central Hospital). This study had no outside funding.


Last updated on 08/06/2026 12:40:12 PM