Incidence of adverse events in antipsychotic-naïve children and adolescents treated with antipsychotic drugs: a French multicentre naturalistic study protocol (ETAPE)

Abstract

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.

Prescribing trends and indications of antipsychotic medication in Hong Kong from 2004 to 2014: General and vulnerable patient groups

“…The better tolerability profile also may have decreased the likelihood of treatment discontinuation, which would have lengthened the duration of prescription and therefore may have increased prevalence, as suggested in a previous study . Other reasons could be an increase in the approved indications of SGAs, which are now approved for the treatment of bipolar mania, adolescent schizophrenia, and behavioural disturbance associated with autism or intellectual disability in children and adolescents …”

“…42 Other reasons could be an increase in the approved indications of SGAs, which are now approved for the treatment of bipolar mania, adolescent schizophrenia, and behavioural disturbance associated with autism or intellectual disability in children and adolescents. 7 With regard to APD prescribing in pregnancy, it was expected that the prevalence would take the "U-shape" pattern (statistically significantly higher prevalence in the timeframes of prepregnancy and postpartum, compared to the pregnancy timeframe). 43 However, this was not the case in our study.…”

“…[2][3][4][5][6] Second-generation antipsychotics were approved for some indications in children and adolescents recently. 7 However, concerns regarding the safety of SGAs use in children (mostly focusing on metabolic syndrome and cardiovascular effects) have been raised. 8,9 Although APDs have been increasingly prescribed during pregnancy, safety evidence is limited.…”

The prescribing pattern of paliperidone in a pediatric population

“…Risperidone has shown evidence for efficacy in disruptive behaviours [23]. Aripiprazole and risperidone are also FDA-approved medications for behavioural disturbances (irritability and aggression) associated with autism and/or intellectual disabilities in children and adolescents (age 6-17 years) [24,18,25].…”

“…In addition to schizophrenia, most second-generation antipsychotics have also been approved to treat BPD [30,31]. As of March 2010, aripiprazole, olanzapine, quetiapine, and risperidone are FDA approved medications for bipolar mania in children and adolescents (age 10-17 years; except olanzapine, age 13-17 years) and for adolescent schizophrenia (age 13-17 years) [24]. In line with the published data in adults, the results of this study show that paliperidone is widely used in those with BPDs [32,33].…”