PMID- 33455928
OWN - NLM
STAT- MEDLINE
DCOM- 20210514
LR  - 20210514
IS  - 2044-6055 (Electronic)
IS  - 2044-6055 (Linking)
VI  - 11
IP  - 1
DP  - 2021 Jan 17
TI  - Monitoring of metabolic adverse events of second-generation antipsychotics in a 
      naive paediatric population followed in mental health outpatient and inpatient 
      clinical settings: MEMAS prospective study protocol.
PG  - e040764
LID - 10.1136/bmjopen-2020-040764 [doi]
LID - e040764
AB  - INTRODUCTION: Second-generation antipsychotics (SGAs) are widely used in the 
      paediatric population. It is currently established that SGAs may induce metabolic 
      adverse events (AEs) such as weight gain, perturbation of blood lipids or glucose 
      with risk of potential cardiovascular morbidity and mortality. The Canadian 
      Alliance for Monitoring Effectiveness and Safety of Antipsychotics in children 
      (CAMESA) has published recommendations for monitoring the metabolic AEs of SGAs. 
      Factors that may be associated with the onset of SGA's metabolic AEs and 
      long-term consequences are less studied in the literature. The objectives of our 
      research are to evaluate some factors that can influence the development of the 
      SGA's metabolic AEs and to study clinical adherence to CAMESA guidelines. METHODS 
      AND ANALYSIS: The Monitoring des Effets Metaboliques des Antipsychotiques de 
      Seconde Generation study is a multicenter, prospective, longitudinal 
      observational study with repeated measures of metabolic monitoring over 24 
      months. Two recruiting centres have been selected for patients under 18 years of 
      age, previously naive of antipsychotics, starting an SGA or who have started an 
      SGA for less than 4 weeks regardless of the diagnosis that motivated the 
      prescription. Assessments are performed for anthropometric measures, blood 
      pressure, blood tests at baseline and 1, 2, 3, 6, 9, 12 and 24 months of 
      follow-up. ETHICS AND DISSEMINATION: The study protocol was approved by the CHU 
      Sainte-Justine's Research Ethics Board (MP-21-2016-1201) in 2016 and obtained 
      institutional suitability for the 'Centre Integre Universitaire de Sante et de 
      Services Sociaux du Nord-de-l'Ile-de-Montreal' Research Center in May 2018. For 
      all participants, written consent will be obtained from parents/caregivers as 
      well as the participant's assent in order to enable their participation in this 
      research project. The results of this research will be published. TRIAL 
      REGISTRATION NUMBER: ClinicalTrials.gov (number NCT04395326).
CI  - (c) Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No 
      commercial re-use. See rights and permissions. Published by BMJ.
FAU - Menard, Marie-Line
AU  - Menard ML
AD  - University Department of Child and Adolescent Psychiatry, Children's Hospitals of 
      Nice CHU-Lenval, Nice, France.
FAU - Ilies, Drigissa
AU  - Ilies D
AUID- ORCID: 0000-0002-8821-7436
AD  - Department of Psychiatry and Addictology, University of Montreal, Montreal, 
      Quebec, Canada.
AD  - Child and Adolescents Psychiatry Division, Department of Psychiatry, 
      Riviere-des-Prairies Mental Health Hospital, CIUSSS-NIM, Montreal, Quebec, 
      Canada.
FAU - Abadie, Pascale
AU  - Abadie P
AD  - Department of Psychiatry and Addictology, University of Montreal, Montreal, 
      Quebec, Canada.
AD  - Child and Adolescents Psychiatry Division, Department of Psychiatry, 
      Riviere-des-Prairies Mental Health Hospital, CIUSSS-NIM, Montreal, Quebec, 
      Canada.
FAU - Jean-Baptiste, Thaina
AU  - Jean-Baptiste T
AD  - Faculty of Pharmacy, University of Montreal, Montreal, Quebec, Canada.
FAU - Choquette, Rachel
AU  - Choquette R
AD  - Faculty of Pharmacy, University of Montreal, Montreal, Quebec, Canada.
FAU - Huet, Anne-Sophie
AU  - Huet AS
AD  - Department of Psychiatry and Addictology, University of Montreal, Montreal, 
      Quebec, Canada.
FAU - Ben Amor, Leila
AU  - Ben Amor L
AUID- ORCID: 0000-0001-7638-3923
AD  - University Department of Child and Adolescent Psychiatry, CHU Sainte-Justine, 
      Montreal, Quebec, Canada leila.ben.amor.hsj@ssss.gouv.qc.ca.
LA  - eng
SI  - ClinicalTrials.gov/NCT04395326
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20210117
PL  - England
TA  - BMJ Open
JT  - BMJ open
JID - 101552874
RN  - 0 (Antipsychotic Agents)
SB  - IM
MH  - Adolescent
MH  - *Antipsychotic Agents/adverse effects
MH  - Canada
MH  - Child
MH  - Humans
MH  - Infant
MH  - Infant, Newborn
MH  - Inpatients
MH  - Mental Health
MH  - Multicenter Studies as Topic
MH  - Observational Studies as Topic
MH  - Outpatients
MH  - Prospective Studies
PMC - PMC7813300
OTO - NOTNLM
OT  - adverse events
OT  - child & adolescent psychiatry
OT  - clinical trials
OT  - public health
COIS- Competing interests: None declared.
EDAT- 2021/01/19 06:00
MHDA- 2021/05/15 06:00
PMCR- 2021/01/17
CRDT- 2021/01/18 05:26
PHST- 2021/01/18 05:26 [entrez]
PHST- 2021/01/19 06:00 [pubmed]
PHST- 2021/05/15 06:00 [medline]
PHST- 2021/01/17 00:00 [pmc-release]
AID - bmjopen-2020-040764 [pii]
AID - 10.1136/bmjopen-2020-040764 [doi]
PST - epublish
SO  - BMJ Open. 2021 Jan 17;11(1):e040764. doi: 10.1136/bmjopen-2020-040764.