CompletedNot Applicable

Trazodone and the Risk of Serious Adverse Events

Canada31,459 participantsStarted 2008-01-01

Plain-language 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.

Who can participate

Age range66 Years

SexALL

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Exclusion criteria

✕. Individuals with missing administrative database number, missing or invalid age (\<0 or \>105 years), missing or invalid sex, death on or before the index date, non-Ontario resident (for Ontario data), or non-Alberta residents (for Alberta data).
✕. Individuals less than 66 years of age on the index date.
✕. Those with evidence of any study drug prescription 180 days before the index date (to restrict to new users only).
✕. Individuals with more than one study drug prescription on the index date, as this complicates the ability to ascertain the prescribed dose accurately.
✕. Individuals with end-stage renal disease, chronic dialysis, or a kidney transplant prior to the index date.
✕. Evidence with hospital discharge or emergency department visit in the two days prior to or on the index date to ensure a new outpatient prescription.
✕. Individuals with no serum creatinine lab value in the 0-365 days prior to the index date.
✕. Individuals with unstable baseline kidney function:

What they're measuring

Number of participants with a composite outcome of all-cause hospitalization or all-cause emergency department visit, or all-cause mortality.

Timeframe: Older adults exposed to high-dose (>75-150 mg/day) versus low-dose (25-75 mg/day) trazodone will enter the cohort and be followed until the study outcome (first event), death, or 30 days from the cohort entry date.

Trial details

NCT IDNCT07381101

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

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-03-01

View on ClinicalTrials.gov More Chronic Kidney Disease (CKD) trials