Trazodone and the Risk of Serious Adverse Events

This is a population-based retrospective, new-user, active comparator cohort study assessing whether initiating a new outpatient prescription of trazodone (\>75-150 mg/day), compared to a lower dose (25-75 mg/day) is associated with an increased 30-day risk of serious adverse events among older adults with low kidney function estimated glomerular filtration rate (eGFR) \<45 mL/min/1.73 m², who are not receiving dialysis and have no history of kidney transplantation. The primary outcome is a 30-day composite of all-cause hospitalization, all-cause emergency department visit, or all-cause mortality.

NCT Number	NCT07381101
Lead Sponsor	London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Conditions	Chronic Kidney Disease (CKD), Older Adults (65 Years and Older)
Enrollment	31,459 participants
Start Date	2008-01-01
Primary Completion	2025-03-01 (estimated)
Study Completion	2025-03-31 (estimated)
Updated on ClinicalTrials.gov	2026-03-05