PMID- 31699516
OWN - NLM
STAT- MEDLINE
DCOM- 20200908
LR  - 20200908
IS  - 1873-7862 (Electronic)
IS  - 0924-977X (Linking)
VI  - 29
IP  - 12
DP  - 2019 Dec
TI  - Incidence of adverse events in antipsychotic-naive children and adolescents 
      treated with antipsychotic drugs: Results of a multicenter naturalistic study 
      (ETAPE).
PG  - 1397-1407
LID - S0924-977X(19)31717-1 [pii]
LID - 10.1016/j.euroneuro.2019.10.006 [doi]
AB  - The main objective of ETAPE study was to determine the incidence of adverse 
      events (AEs) potentially related to antipsychotic (AP) during a 12-months 
      observational study of naturalistic treatment. ETAPE is a naturalistic 
      prospective multicenter study conducted between April 2013 and May 2016. 200 
      patients were included. The mean age was 12 +/- 3 years, with 73.6% being males. 
      Patients presented a significant clinical improvement over time. At baseline, 92% 
      of patients received a second generation AP, 74% AP monotherapy and 79.5% 
      off-label AP prescriptions. Clinical diagnoses were heterogeneous including 
      psychosis, anxiety, mood and neurodevelopmental disorders. The overall AE 
      incidence rate was 11.52 AEs per person-years. Among AEs potentially attributable 
      to AP, 15.4% were neuromotor, 14.8% gastroenterological, 12.2% metabolic and 
      11.8% general symptoms. Weight and body mass index increased significantly. More 
      than half of AE appeared during the first 3 months, but onset of AE was noted all 
      over follow-up. The presence of AEs was stable over time. ETAPE study highlights 
      a high incidence rate of AE in children treated with AP. A careful and continuous 
      clinical and biological monitoring is required to adapt treatment decisions based 
      on benefice-risk-analysis. Moreover, additional research is warranted, also in 
      regard of high proportion of off-label prescriptions.
CI  - Copyright (c) 2019 Elsevier B.V. and ECNP. All rights reserved.
FAU - Menard, Marie-Line
AU  - Menard ML
AD  - University Department of Child and Adolescent Psychiatry, Children's Hospitals of 
      Nice CHU-Lenval, 57 avenue de la Californie, 06200 Nice, France; CoBTek, EA7276, 
      University of Cote d'Azur, Nice, France. Electronic address: 
      menard.ml@pediatrie-chulenval-nice.fr.
FAU - Thummler, Susanne
AU  - Thummler S
AD  - University Department of Child and Adolescent Psychiatry, Children's Hospitals of 
      Nice CHU-Lenval, 57 avenue de la Californie, 06200 Nice, France; CoBTek, EA7276, 
      University of Cote d'Azur, Nice, France.
FAU - Giannitelli, Marianna
AU  - Giannitelli M
AD  - Department of Child and Adolescent Psychiatry, GH Pitie-Salpetriere, APHP, Paris, 
      France; CNRS UMR 7222 Institut des Systemes Intelligents et Robotiques, Pierre & 
      Marie Curie University, Paris, France.
FAU - Cruzel, Coralie
AU  - Cruzel C
AD  - Department of Clinical Research and Innovation (DRCI), Nice University Hospital, 
      Nice, France.
FAU - Bonnot, Olivier
AU  - Bonnot O
AD  - Department of Child and Adolescent Psychiatry, University Hospital, Nantes, 
      France.
FAU - Cohen, David
AU  - Cohen D
AD  - Department of Child and Adolescent Psychiatry, GH Pitie-Salpetriere, APHP, Paris, 
      France; CNRS UMR 7222 Institut des Systemes Intelligents et Robotiques, Pierre & 
      Marie Curie University, Paris, France.
FAU - Askenazy, Florence
AU  - Askenazy F
AD  - University Department of Child and Adolescent Psychiatry, Children's Hospitals of 
      Nice CHU-Lenval, 57 avenue de la Californie, 06200 Nice, France; CoBTek, EA7276, 
      University of Cote d'Azur, Nice, France.
CN  - ETAPE Study Group
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Pragmatic Clinical Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20191104
PL  - Netherlands
TA  - Eur Neuropsychopharmacol
JT  - European neuropsychopharmacology : the journal of the European College of 
      Neuropsychopharmacology
JID - 9111390
RN  - 0 (Antipsychotic Agents)
SB  - IM
MH  - Adolescent
MH  - Antipsychotic Agents/*adverse effects
MH  - Child
MH  - Drug-Related Side Effects and Adverse Reactions/*diagnosis/*epidemiology
MH  - Female
MH  - Follow-Up Studies
MH  - Humans
MH  - Incidence
MH  - Male
MH  - Neurodevelopmental Disorders/*drug therapy/*epidemiology/psychology
MH  - Prospective Studies
MH  - Psychotic Disorders/drug therapy/epidemiology/psychology
OTO - NOTNLM
OT  - Adverse events
OT  - Antipsychotics
OT  - Child and adolescent psychiatry
OT  - Pediatric population
OT  - Psychotropics
FIR - Boublil, Michel
IR  - Boublil M
IRAD- CAMPS de Grasse, Grasse, France.
FIR - Chambry, Jean
IR  - Chambry J
IRAD- Fondation Vallee, Gentilly, France.
FIR - Charvet, Dorothee
IR  - Charvet D
IRAD- Unite de Soins pour Adolescents Ulysse, Saint Jean de Dieu Hospital, Lyon, 
      France.
FIR - Cseterky, Mona
IR  - Cseterky M
IRAD- Princess Grace Hospital Centre, Monaco.
FIR - Fontas, Eric
IR  - Fontas E
IRAD- Department of Clinical Research and Innovation, Nice University Hospital, Nice, 
      France.
FIR - Fourneret, Pierre
IR  - Fourneret P
IRAD- Hopital Femme Mere Enfant, Fondation Hospices Civils de Lyon, Lyon, France.
FIR - Gicquel, Ludovic
IR  - Gicquel L
IRAD- Henri Laborit Hospital, Poitiers, France.
FIR - Kabuth, Bernard
IR  - Kabuth B
IRAD- Department of Child and Adolescent Psychiatry, Brabois Vandoeuvre-les-Nancy 
      Hospital, France.
FIR - Leroy, Bernard
IR  - Leroy B
IRAD- Pole Parents-Femme-Enfant, Cannes Hospital, France.
FIR - Maria, Fanny
IR  - Maria F
IRAD- University Department of Child and Adolescent Psychiatry, Children's Hospitals of 
      Nice CHU-Lenval, Nice, France.
FIR - Moceri, Pamela
IR  - Moceri P
IRAD- Children's Hospitals of Nice CHU-Lenval, Nice, France.
FIR - Parassol-Girard, Nadege
IR  - Parassol-Girard N
IRAD- University Department of Child and Adolescent Psychiatry, Children's Hospitals of 
      Nice CHU-Lenval, Nice, France.
FIR - Ravis, Brigitte
IR  - Ravis B
IRAD- CIC 1407 Inserm - Hospices Civils de Lyon, Lyon, France.
FIR - Raynaud, Jean-Philippe
IR  - Raynaud JP
IRAD- University Department of Child and Adolescent Psychiatry, Toulouse University 
      Hospital, Toulouse, France.
FIR - Roche, Jean-Francois
IR  - Roche JF
IRAD- Department of Child and Adolescent Psychiatry, Esquirol Hospital, Limoges, 
      France.
FIR - Rochet, Thierry
IR  - Rochet T
IRAD- Hospital Center Le Vinatier, Bron, France.
EDAT- 2019/11/09 06:00
MHDA- 2020/09/09 06:00
CRDT- 2019/11/09 06:00
PHST- 2019/06/07 00:00 [received]
PHST- 2019/10/10 00:00 [revised]
PHST- 2019/10/15 00:00 [accepted]
PHST- 2019/11/09 06:00 [pubmed]
PHST- 2020/09/09 06:00 [medline]
PHST- 2019/11/09 06:00 [entrez]
AID - S0924-977X(19)31717-1 [pii]
AID - 10.1016/j.euroneuro.2019.10.006 [doi]
PST - ppublish
SO  - Eur Neuropsychopharmacol. 2019 Dec;29(12):1397-1407. doi: 
      10.1016/j.euroneuro.2019.10.006. Epub 2019 Nov 4.