Status:
UNKNOWN
Monitoring of Metabolic Adverse Events of Second Generation Antipsychotics in a Naive Pediatric Population
Lead Sponsor:
St. Justine's Hospital
Collaborating Sponsors:
Ciusss de L'Est de l'Île de Montréal
Conditions:
Adverse Drug Event
Eligibility:
All Genders
Up to 18 years
Brief Summary
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 w...
Detailed Description
Objectives The primary objective is to study selected factors that can influence the development of the SGA's metabolic AEs such as the main diagnosis for which the SGA is prescribed, comorbidities, t...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2017
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT04395326
Start Date
January 1 2017
End Date
December 31 2025
Last Update
May 20 2020
Active Locations (1)
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1
Ben Amor Leila
Montreal, Quebec, Canada, H3T 1C5