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Monitoring of Metabolic Adverse Events of Second Generation Antipsychotics in a Naive Pediatric Population

Adverse Drug Event

Introduction: Second Generation Antipsychotics (SGAs) are widely used in the pediatric population. It is currently established that SGAs may induce undesirable metabolic adverse events (AEs) such as weight gain, metabolic changes in 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 in the pediatric population. 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 MEMAS study (Monitoring des Effets Métaboliques des Antipsychotiques de Seconde Génération) design is a multicenter, prospective, longitudinal observational study with repeated measures of metabolic monitoring up to 24 months of follow-up. Two recruiting centers have been selected for patients under 18 years of age, previously naïve 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 at inclusion and during follow-up for anthropometric measures (AM), blood pressure (BP) and blood tests (BT) 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 Centre Hospitalier Universitaire (CHU) Sainte-Justine's Research Ethics Board (MP-21-2016-1201) in 2016 and obtained institutional suitability for the "Centre Intégré Universitaire de Santé et de Services Sociaux du Nord-de-l'Île-de-Montréal" (CIUSSS NIM) 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.

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Conditions de participation

  • Sexe:

    ALL

  • Âges admissibles:

    0 to 18

Critères de participation

Inclusion Criteria:

* patients under 18 years of age,
* previously AP-naifs,
* starting an SGA or who started an SGA for less than 4 weeks,
* followed longitudinally at one of the selected recruiting center,
* regardless of the diagnosis that motivated the prescription of the SGA medication.

Exclusion Criteria:

* diabetes,
* dyslipidemia,
* high blood pressure,
* thyroid dysfunction,
* hepatic disease,
* hyperprolactinemia,
* taking a medication to treat any of the above conditions before starting SGA treatment and pregnancy.

Lieu de l'étude

Ben Amor Leila
Ben Amor Leila
Montréal, Quebec
Canada

Contactez l'équipe d'étude

Backup Contact

Drigissa Ilies, MD, MSc

Primary Contact

Leila Ben Amor, MD, MSc

[email protected]
(1) 514 345 4931
Étude parrainée par
St. Justine's Hospital
Participants recherchés
Plus d'informations
ID de l'étude: NCT04395326