Preliminary and ongoing French multicenter prospective naturalistic study of adverse events of antipsychotic treatment in naive children and adolescents

Abstract

BackgroundThe prescription of antipsychotics (AP), and especially second generation AP, is increasing worldwide in the pediatric population. Most prescriptions are off-label and despite the identification of frequent and potentially severe adverse events (AE), there are only a few guidelines for the safety management. France is one of the countries with no official safety guidelines.MethodsPsychotropic drug-naive adolescents (13–18 years), hospitalized for an acute psychotic episode and treated with a second-generation antipsychotic were consecutively included in a prospective cohort study. Patients were assessed for their AE at baseline, 2, 6 and 12 weeks after the introduction of drug.ResultsThe majority of patients was treated with risperidone (n = 13), 2 with aripiprazole. The principal findings are: (1) A high incidence of neuromuscular AE: 8/15 muscle weakness, 8/15 extrapyramidal syndrome, 6/15 akathisia, 3/15 oro-facial acute dystonia; (2) Severe catatonia symptoms in 2 patients despite a low to moderate treatment dose, requiring transfer in intensive care unit for one; (3) Weight gain and significant increase of the BMI for all 13 patients who had a 12 weeks follow-up.ConclusionAll adolescents experienced AE, with significant weight gain being observed in all patients who completed the 12-week follow-up. The fact that our patient population was first episode drug naïve may partially explain this observation. Despite the limitation due to the small sample size of this prospective short-term study, such findings are important to report and warrant further research.Clinical and research implicationBecause of the lack of naturalistic follow up studies of antipsychotic treatments in AP-naive children and adolescents and the absence of safety guidelines for the pediatric population in France, we decided to continue our research at a national level. We therefore started a prospective, naturalistic and multicenter study funded by the French National Agency for Medicines and Health Products Safety (ANSM). Study purpose is to evaluate the incidence of adverse events related to antipsychotic drugs in AP-naive children and adolescents. In addition, we aim to provide further evidence for the necessity of national safety guidelines for AP prescription in the pediatric population.

Unmet needs in paediatric psychopharmacology: Present scenario and future perspectives

“…The French multicenter prospective naturalistic study of adverse events of antipsychotic treatment in naïve children and adolescents, funded by French National Agency for Medicines and Health Products Safety (Menard et al, 2014; id. NCT02007928 on www.clinicaltrials.gov); SENTIA: a systematic online monitoring registry for children and adolescents treated with antipsychotics, supported by the Spanish Ministry of Health and Social Politics (Palanca-Maresca et al, 2014);…”

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

“…ETAPE is a naturalistic prospective multicentre study. 34 35 Patients were recruited over a period of 25 months (from April 2013 to May 2015). A total of 200 patients have been enrolled in 10 University Departments of Child and Adolescent Psychiatry (Children's Hospitals of NICE CHU-Lenval, NICE; University Hospital Pitié Salpêtrière, Paris; Nantes University Hospital, Nantes; Lille University Hospital, Lille; Nancy University Hospital, Nancy; Esquirol Hospital, Limoges; Lyon University Hospitals (HCL Lyon, CH Vinatier, St Jean de Dieu); Toulouse University Hospital, Toulouse; Hospital Fondation Vallée, Gentilly; Poitiers University Hospital, Poitiers; Monaco Hospital) ( figure 2 ).…”

Risperidone - A Probable Cause of Guillain-Barre Syndrome: A Case Report

“…Risperidone, one of the second-generation antipsychotic drugs, has been used in attention-deficit/hyperactivity disorder (ADHD), behavioral problems associated with autistic disorder, in addition to psychotic disorders [1]. Although second-generation antipsychotic drugs have a more safety profile than first-generation drugs, adverse drug reactions which are usually related with treatment time and higher dose of risperidone have been increasingly reported in line with expanding clinical use [2]. Studies evaluated the effect of risperidone on cytokine levels pointed that cytokines which are the major component of humoral immunity fluctuate during risperidone treatment.…”