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

• Published in: BMJ open Vol. 6; no. 4; p. e011020
• Main Authors: Menard, Marie-Line, Thümmler, Susanne, Giannitelli, Marianna, Olliac, Bertrand, Bonnot, Olivier, Cohen, David, Askenazy, Florence, Michel, Boublil, Agnès, Castaings, Jean, Chambry, Dorothée, Charvet, Mona, Cseterky, Eric, Fontas, Pierre, Fourneret, Ludovic, Gicquel, Bernard, Kabuth, Bernard, Leroy, Fanny, Maria, Pamela, Moceri, Jean-Philippe, Raynaud, Jean-François, Roche, Thierry, Rochet
• Format: Journal Article
• Language: English
• Published: England British Medical Journal Publishing Group 06-04-2016; BMJ Publishing Group LTD; BMJ Publishing Group
• Subjects: Adolescent; Adults; Age; Antipsychotic Agents - adverse effects; Antipsychotic Agents - therapeutic use; Antipsychotics; Body mass index; Catatonia; Child; Child & adolescent psychiatry; Child psychology; Children & youth; Diabetes; Drug Monitoring; Electrocardiography; FDA approval; Female; France; High density lipoprotein; Human health and pathology; Humans; Incidence; Insulin resistance; Laboratories; Life Sciences; Male; Mental Disorders - drug therapy; Metabolism; Paediatrics; Pediatrics; Pharmaceutical sciences; Pharmacology; Population; Prescription drugs; Prescriptions; Prospective Studies; Psychiatrics and mental health; Psychotropic drugs; Questionnaires; Research Design; Santé publique et épidémiologie; Schizophrenia; Teenagers; France; Monaco; United States > US
• ISSN: 2044-6055; 2044-6055
• DOI: 10.1136/bmjopen-2015-011020

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.