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Trazodone and the Risk of Serious Adverse Events

NCT07381101 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 31459

Last updated 2026-03-05

No results posted yet for this study

Summary

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.

Conditions

  • Chronic Kidney Disease (CKD)
  • Older Adults (65 Years and Older)

Interventions

DRUG

Trazodone HCl

The primary exposure of interest will be oral trazodone at a dose \>75-150 mg/day.

Sponsors & Collaborators

  • London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

    lead OTHER

Eligibility

Min Age
66 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-01-01
Primary Completion
2025-03-01
Completion
2025-03-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07381101 on ClinicalTrials.gov