Clinical Trial

Sertraline and the Risk of Serious Adverse Events

Completed
View on ClinicalTrials.gov →
Summary
The goal of this population-based cohort study is to assess the safety of initiating a new outpatient prescription of 50 mg/day of Sertraline, a higher dose, compared to 25 mg/day, a lower dose, in adults aged 65+ with low kidney function. The primary question is whether initiating a new outpatient prescription of a higher dose of Sertraline (50mg/day) compared to a lower dose (25 mg/day) in older adults with low kidney function (an eGFR \<45 mL/min per 1.73 m2, but not receiving dialysis or having a history of kidney transplantation) is associated with a higher 30-day risk. The outcome measured will be a composite of all-cause hospitalization, all-cause emergency department visit, or all-cause mortality.
Trial Details
NCT Number NCT07387120
Lead Sponsor London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Conditions Chronic Kidney Disease (CKD), Elderly, Outpatient
Enrollment 6,893 participants
Start Date 2008-01
Primary Completion 2025-01 (estimated)
Study Completion 2026-01 (estimated)
Updated on ClinicalTrials.gov 2026-02-04