Objective: To review the use of aripiprazole in children and adolescents. Methods: Medline and Embase databases were systematically searched using the keywords aripiprazole and child or adolescent over the period from 2000 to 2019. The initial screen yielded 163 publications, from which 99 studies were reviewed. Results: Aripiprazole is one of the most widely prescribed atypical antipsychotics. Like others, its use in children and adolescents is becoming commonplace and occurs in off-label indications. Aripiprazole has proven efficacy for several indications in children and adolescents, including schizophrenia, bipolar disorder, Tourette's syndrome, and behavioral impairments associated with autism and intellectual disability. Adverse effects are more important in children and adolescents than adults, particularly weight gain, drowsiness, extrapyramidal effects, and metabolic effects, even though the latter may appear less important than with other atypical antipsychotics. Severe adverse effects often occur in multiple-prescription settings. At present, postprescription monitoring is very poor. Conclusion: Aripiprazole has proven efficacy for several indications in children and adolescents. However, its use requires clinical and paraclinical monitoring to assess the occurrence of adverse events that may challenge the benefit/risk ratio. In addition, off-label prescriptions should be limited, as they appear to account for a significant proportion of aripiprazole use worldwide.

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IntroductionIn France, over recent years, the prescription rate of antipsychotic (AP) remained stable in children and adolescents. Prescription of second-generation antipsychotics increased, whereas prescription of first-generation antipsychotics decreased. Off-label prescriptions are very frequent in this population. Adverse events (AEs) in youth treated with AP are common and may be severe. AEs have hitherto been poorly monitored in naturalistic studies independent from industry.Method and analysisWe describe a French prospective multicentre study in an AP-naïve paediatric population named Etude de la Tolérance des AntiPsychotique chez l'Enfant (ETAPE). The study started in April 2013. So far, 200 patients have been included. The inclusion criteria are: male or female inpatients aged from 6 to 18 years, treated with an AP drug for less than 28 days, never been treated or having received AP for less than 3 months, discontinued at least 6 months prior to inclusion. These assessments of AE are performed at inclusion, as well as at 3, 6, 9 and 12 months after the introduction of the AP. The monitoring period will end in May 2016.Ethics and disseminationThe study protocol was approved by the Ethics Committee ‘Sud Méditerrané V’ (number 12.082) and by the French National Agency for Medicines and Health Products Safety (number 2012-004546-15). All patients and their parents signed informed consent on enrolment in the study. We will submit the results of the study to relevant journals and offer national and international presentations. This study will enable better characterisation of the prescription of AP drugs. The results will further help to develop quality standards and recommendations for monitoring AE during the prescription of AP.Trial registration numberNCT02007928.

Opinion statementSecond-generation antipsychotics (SGAs) have been proven effective in treating several psychiatric conditions in children and adolescents. These atypical antipsychotic medications are being used with increasing frequency in Europe, the U.S., and Canada. We aim to expose shortterm and long-term adverse effects (AEs) of SGAs in youth populations and to provide management recommendations for major adverse effects. These proposals are based on (1) an indepth literature review of both short-and long-term studies on the use of SGAs in youth; (2) our own clinical experience in managing such treatment in this population; and (3) the work of the Canadian Alliance for Monitoring Effectiveness and Safety of Antipsychotics in Children (CAMESA). AEs are frequent in youth treated with SGAs, and include primarily weight gain, metabolic and hormonal changes, somnolence, extrapyramidal syndrome, and QT modifications. However, frequency and type of AE vary according to compound, and each compound's AE profile is specific. Acknowledgment of these distinct profiles should aid clinicians in making treatment decisions. After an SGA is prescribed, routine monitoring of AEs is recommended, and should an AE occur, clinical management recommendations should be followed. To date, there are no clinically validated monitoring recommendations.