title: Incidence of adverse events in antipsychotic-naïve children and adolescents treated with antipsychotic drugs: a French multicentre naturalistic study protocol (ETAPE).
abstract: BACKGROUND
  In 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.
  
  
  METHODS
  We 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.
  
  
  BACKGROUND
  The 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.
  
  
  BACKGROUND
  NCT02007928.
authors.affiliation: University Department of Child and Adolescent Psychiatry, Children's Hospitals of NICE CHU-Lenval, NICE, France CoBTek, EA7276, University of NICE Sophia Antipolis, Nice, France.
authors.forename: Marie-Line
authors.initials: ML
authors.lastname: Menard
authors.affiliation: University Department of Child and Adolescent Psychiatry, Children's Hospitals of NICE CHU-Lenval, NICE, France CoBTek, EA7276, University of NICE Sophia Antipolis, Nice, France.
authors.forename: Susanne
authors.initials: S
authors.lastname: Thümmler
authors.affiliation: Department of Child and Adolescent Psychiatry, GH Pitié-Salpêtrière, APHP, Paris, France GRC-PSYDEV, Université Pierre et Marie Curie, Hôpital Piété-Salpêtrière, AP-HP, Paris, France.
authors.forename: Marianna
authors.initials: M
authors.lastname: Giannitelli
authors.affiliation: Department of Child and Adolescent Psychiatry, Esquirol Hospital, Limoges, France.
authors.forename: Bertrand
authors.initials: B
authors.lastname: Olliac
authors.affiliation: Department of Child and Adolescent Psychiatry, Nantes University Hospital, Nantes, France.
authors.forename: Olivier
authors.initials: O
authors.lastname: Bonnot
authors.affiliation: Department of Child and Adolescent Psychiatry, GH Pitié-Salpêtrière, APHP, Paris, France CNRS UMR 7222 Institut des Systèmes Intelligents et Robotiques, Université Pierre et Marie Curie, Paris, France.
authors.forename: David
authors.initials: D
authors.lastname: Cohen
authors.affiliation: University Department of Child and Adolescent Psychiatry, Children's Hospitals of NICE CHU-Lenval, NICE, France CoBTek, EA7276, University of NICE Sophia Antipolis, Nice, France.
authors.forename: Florence
authors.initials: F
authors.lastname: Askenazy
mesh_terms: D000293:Adolescent; D014150:Antipsychotic Agents / Q000009:adverse effects* / Q000627:therapeutic use; D002648:Child; D016903:Drug Monitoring; D005260:Female; D005602:France; D006801:Humans; D015994:Incidence; D008297:Male; D001523:Mental Disorders / Q000188:drug therapy*; D010372:Pediatrics; D055656:Prescriptions; D011446:Prospective Studies; D012107:Research Design; D012559:Schizophrenia
chemical_list: D014150:Antipsychotic Agents